Mupirocin cream is indicated for the treatment of secondarily infected traumatic skin lesions (up to 10 cm in length or 100 cm2in area) due to susceptible isolates of Staphylococcus aureus (S. aureus) and Streptococcus pyogenes (S. pyogenes).

{ "type": "p", "children": [], "text": "\nMupirocin cream is indicated for the treatment of secondarily infected traumatic skin lesions (up to 10 cm in length or 100 cm2in area) due to susceptible isolates of Staphylococcus aureus (S. aureus) and Streptococcus pyogenes (S. pyogenes)." }

{ "type": "ul", "children": [ "  For Topical Use Only.", "  Apply a small amount of mupirocin cream, with a cotton swab or gauze pad, to the affected area 3 times daily for 10 days.", "  Cover the treated area with gauze dressing if desired.", "  Re-evaluate patients not showing a clinical response within 3 to 5 days.", "  Mupirocin cream is not for intranasal, ophthalmic, or other mucosal use [see Warnings and Precautions (5.2, 5.6)].\n", "  Do not apply mupirocin cream concurrently with any other lotions, creams or ointments [see Clinical Pharmacology (12.3)].\n" ], "text": "" }

Mupirocin cream USP, 2% is a white to off white cream that contains 20 mg (2% w/w) of mupirocin per gram in an oil-and water-based emulsion, supplied in 15-gram and 30-gram tubes.

{ "type": "p", "children": [], "text": "\nMupirocin cream USP, 2% is a white to off white cream that contains 20 mg (2% w/w) of mupirocin per gram in an oil-and water-based emulsion, supplied in 15-gram and 30-gram tubes." }

Mupirocin cream is contraindicated in patients with known hypersensitivity to mupirocin or any of the excipients of mupirocin cream.

{ "type": "p", "children": [], "text": "\nMupirocin cream is contraindicated in patients with known hypersensitivity to mupirocin or any of the excipients of mupirocin cream." }

Systemic allergic reactions, including anaphylaxis, urticaria, angioedema, and generalized rash, have been reported in patients treated with formulations of mupirocin, including mupirocin cream [see Adverse Reactions (6.2)].

Avoid contact with the eyes. In case of accidental contact, rinse well with water.

In the event of a sensitization or severe local irritation from mupirocin cream, usage should be discontinued, and appropriate alternative therapy for the infection instituted.

Clostridium difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.

C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin-producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibacterial drug use. Careful medical history is necessary since CDAD has been reported to occur over 2 months after the administration of antibacterial agents.

If CDAD is suspected or confirmed, ongoing antibacterial drug use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibacterial treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.

As with other antibacterial products, prolonged use of mupirocin cream may result in overgrowth of nonsusceptible microorganisms, including fungi [see Dosage and Administration (2)].

Mupirocin cream is not formulated for use on mucosal surfaces. A separate formulation, BACTROBAN (mupirocin calcium) nasal ointment, is available for intranasal use.

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice.

In 2 randomized, double‑blind, double‑dummy trials, 339 subjects were treated with topical mupirocin cream plus oral placebo. Adverse reactions occurred in 28 (8.3%) subjects. The following adverse reactions were reported by at least 1% of subjects in connection with the use of mupirocin cream in clinical trials: headache (1.7%), rash (1.1%), and nausea (1.1%).

Other adverse reactions which occurred in less than 1% of subjects were: abdominal pain, burning at application site, cellulitis, dermatitis, dizziness, pruritus, secondary wound infection, and ulcerative stomatitis.

In a supportive trial in the treatment of secondarily infected eczema, 82 subjects were treated with mupirocin cream. The incidence of adverse reactions was as follows: nausea (4.9%), headache and burning at application site (3.6% each), pruritus (2.4%), and 1 report each of abdominal pain, bleeding secondary to eczema, pain secondary to eczema, hives, dry skin, and rash.

In addition to adverse reactions reported from clinical trials, the following reactions have been identified during postmarketing use of mupirocin cream. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These reactions have been chosen for inclusion due to a combination of their seriousness, frequency of reporting, or potential causal relationship to mupirocin cream.

Immune System Disorders

Systemic allergic reactions, including anaphylaxis, urticaria, angioedema, and generalized rash [see Warnings and Precautions (5.1)].

Risk Summary

There are insufficient human data to establish whether there is a drug-associated risk with mupirocin cream in pregnant women. Systemic absorption of mupirocin through intact human skin is minimal following topical administration of mupirocin cream [see Clinical Pharmacology (12.3)]. No developmental toxicity was observed in rats or rabbits treated with mupirocin subcutaneously during organogenesis at doses of 160 or 40 mg per kg per day, respectively (22 and 11 times the human topical dose based on calculations of dose divided by the entire body surface area).

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. The estimated background risk in the U.S. general population of major birth defects is 2% to 4% and of miscarriage is 15% to 20% of clinically recognized pregnancies.

Data

Animal Data: Developmental toxicity studies have been performed with mupirocin administered subcutaneously to rats and rabbits at doses up to 160 mg per kg per day during organogenesis. This dose is 22 and 43 times, respectively, the human topical dose (approximately 60 mg mupirocin per day) based on calculations of dose divided by the entire body surface area. Maternal toxicity was observed (body weight loss/decreased body weight gain and reduced feeding) in both species with no evidence of developmental toxicity in rats. In rabbits, excessive maternal toxicity at the high dose precluded the evaluation of fetal outcomes. There was no developmental toxicity in rabbits at 40 mg per kg per day, 11 times the human topical dose based on calculations of dose divided by the entire body surface area.

Mupirocin administered subcutaneously to rats in a prenatal and postnatal development study (dosed during late gestation through lactation) was associated with reduced offspring viability in the early postnatal period at a dose of 106.7 mg per kg, in the presence of injection site irritation and/or subcutaneous hemorrhaging. This dose is 14 times the human topical dose based on calculations of dose divided by the entire body surface area. The no-observed adverse effect level in this study was 44.2 mg per kg per day, which is 6 times the human topical dose.

Risk Summary

It is not known whether mupirocin is present in human milk, has effects on the breastfed child, or has effects on milk production. However, breastfeeding is not expected to result in exposure of the child to the drug due to the minimal systemic absorption of mupirocin in humans following topical administration of mupirocin cream [see Clinical Pharmacology (12.3)]. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for mupirocin cream and any potential adverse effects on the breastfed child from mupirocin cream or from the underlying maternal condition.

Clinical Considerations

To minimize oral exposure of the drug to children, a breast and/or nipple being treated with mupirocin cream should be thoroughly washed prior to breastfeeding.

The safety and effectiveness of mupirocin cream have been established in the age-groups 3 months to 16 years. Use of mupirocin cream in these age-groups is supported by evidence from adequate and well‑controlled trials of mupirocin cream in adults with additional data from 93 pediatric subjects studied as part of the pivotal trials in adults [see Clinical Studies (14)].

In 2 adequate and well‑controlled trials, 30 subjects older than 65 years were treated with mupirocin cream. No overall difference in the efficacy or safety of mupirocin cream was observed in this patient population when compared with that observed in younger patients.

Mupirocin cream USP, 2% contains the dihydrate crystalline calcium hemi-salt of the RNA synthetase inhibitor antibacterial, mupirocin. Chemically, it is (αE,2S,3R,4R,5S)-5-[(2S,3S,4S,5S)-2,3-epoxy-5-hydroxy-4-methylhexyl]tetrahydro-3,4-dihydroxy-β-methyl-2H-pyran-2-crotonic acid, ester with 9-hydroxynonanoic acid, calcium salt (2:1), dihydrate.

{ "type": "p", "children": [], "text": "\nMupirocin cream USP, 2% contains the dihydrate crystalline calcium hemi-salt of the RNA synthetase inhibitor antibacterial, mupirocin. Chemically, it is (αE,2S,3R,4R,5S)-5-[(2S,3S,4S,5S)-2,3-epoxy-5-hydroxy-4-methylhexyl]tetrahydro-3,4-dihydroxy-β-methyl-2H-pyran-2-crotonic acid, ester with 9-hydroxynonanoic acid, calcium salt (2:1), dihydrate." }

The molecular formula of mupirocin calcium is (C26H43O9)2Ca•2H2O, and the molecular weight is 1075.3. The molecular weight of mupirocin free acid is 500.6. The structural formula of mupirocin calcium is:

{ "type": "p", "children": [], "text": "The molecular formula of mupirocin calcium is (C26H43O9)2Ca•2H2O, and the molecular weight is 1075.3. The molecular weight of mupirocin free acid is 500.6. The structural formula of mupirocin calcium is: " }

Each gram of mupirocin cream USP, 2% contains 20 mg (2% w/w) of mupirocin equivalent to 21.5 mg (2.15% w/w) of mupirocin calcium, USP. The inactive ingredients are benzyl alcohol, glycerol monostearate, mineral oil, phenoxyethanol, polyoxyl 20 cetostearyl ether, purified water, and xanthan gum.

{ "type": "p", "children": [], "text": "\nEach gram of mupirocin cream USP, 2% contains 20 mg (2% w/w) of mupirocin equivalent to 21.5 mg (2.15% w/w) of mupirocin calcium, USP. The inactive ingredients are benzyl alcohol, glycerol monostearate, mineral oil, phenoxyethanol, polyoxyl 20 cetostearyl ether, purified water, and xanthan gum." }

Mupirocin is an RNA synthetase inhibitor antibacterial [see Microbiology (12.4)].

Absorption

Systemic absorption of mupirocin through intact human skin is minimal. The systemic absorption of mupirocin was studied following application of mupirocin cream 3 times daily for 5 days to various skin lesions greater than 10 cm in length or 100 cm2 in area in 16 adults (aged 29 to 60 years) and 10 children (aged 3 to 12 years). Some systemic absorption was observed as evidenced by the detection of the metabolite, monic acid, in urine. Data from this trial indicated more frequent occurrence of percutaneous absorption in children (90% of subjects) compared with adults (44% of subjects); however, the observed urinary concentrations in children (0.07 to 1.3 mcg per mL [1 pediatric subject had no detectable level]) are within the observed range (0.08 to 10.03 mcg per mL [9 adults had no detectable level]) in the adult population. In general, the degree of percutaneous absorption following multiple dosing appears to be minimal in adults and children.

The effect of the concurrent application of mupirocin cream with other topical products has not been studied [see Dosage and Administration (2)].

Elimination

In a trial conducted in 7 healthy adult male subjects, the elimination half-life after intravenous administration of mupirocin was 20 to 40 minutes for mupirocin and 30 to 80 minutes for monic acid.

Metabolism: Following intravenous or oral administration, mupirocin is rapidly metabolized. The principal metabolite, monic acid, demonstrates no antibacterial activity.

Excretion: Monic acid is predominantly eliminated by renal excretion.

Mupirocin is an RNA synthetase inhibitor antibacterial produced by fermentation using the organism Pseudomonas fluorescens.

Mechanism of Action

Mupirocin inhibits bacterial protein synthesis by reversibly and specifically binding to bacterial isoleucyl-transfer RNA (tRNA) synthetase.

Mupirocin is bactericidal at concentrations achieved by topical administration. Mupirocin is highly protein bound (greater than 97%) and the effect of wound secretions on the minimum inhibitory concentrations (MICs) of mupirocin has not been determined.

Resistance

When mupirocin resistance occurs, it results from the production of a modified isoleucyl-tRNA synthetase, or the acquisition of, by genetic transfer, a plasmid mediating a new isoleucyl-tRNA synthetase. High-level plasmid-mediated resistance (MIC ≥512 mcg/mL) has been reported in increasing numbers of isolates of S. aureus and with higher frequency in coagulase-negative staphylococci. Mupirocin resistance occurs with greater frequency in methicillin-resistant than methicillin-susceptible staphylococci.

Cross Resistance

Due to its mode of action, mupirocin does not demonstrate cross resistance with other classes of antimicrobial agents.

Antimicrobial Activity

Mupirocin has been shown to be active against susceptible isolates of S. aureus and S. pyogenes, both in vitro and in clinical trials [see Indications and Usage (1)]. The following in vitro data are available, but their clinical significance is unknown. Mupirocin is active against most isolates of Staphylococcus epidermidis.

Susceptibility Test Methods

High-level mupirocin resistance (≥512 mcg/mL) may be determined using standard disk diffusion or broth microdilution tests.1,2 Because of the occurrence of mupirocin resistance in methicillin-resistant S. aureus (MRSA), it is appropriate to test MRSA populations for mupirocin susceptibility prior to the use of mupirocin using a standardized method.3,4,5

Long‑term studies in animals to evaluate carcinogenic potential of mupirocin calcium have not been conducted.

Results of the following studies performed with mupirocin calcium or mupirocin sodium in vitro and in vivo did not indicate a potential for genotoxicity: rat primary hepatocyte unscheduled DNA synthesis, sediment analysis for DNA strand breaks, Salmonella reversion test (Ames), Escherichia coli mutation assay, metaphase analysis of human lymphocytes, mouse lymphoma assay, and bone marrow micronuclei assay in mice.

In a fertility/reproductive performance study (with dosing through lactation), mupirocin administered subcutaneously to male and female rats at doses up to 100 mg per kg per day which is 14 times the human topical dose (approximately 60 mg mupirocin per day) based on calculations of dose divided by the entire body surface area, did not result in impaired fertility or impaired reproductive performance attributable to mupirocin.

The efficacy of topical mupirocin cream for the treatment of secondarily infected traumatic skin lesions (e.g., lacerations, sutured wounds, and abrasions not more than 10 cm in length or 100 cm2 in total area) was compared with that of oral cephalexin in 2 randomized, double‑blind, double‑dummy clinical trials. Clinical efficacy rates at follow‑up in the per-protocol populations (adults and pediatric subjects included) were 96.1% for mupirocin cream (n = 231) and 93.1% for oral cephalexin (n = 219). Pathogen eradication rates at follow‑up in the per-protocol populations were 100% for both mupirocin cream and oral cephalexin.

{ "type": "p", "children": [], "text": "\nThe efficacy of topical mupirocin cream for the treatment of secondarily infected traumatic skin lesions (e.g., lacerations, sutured wounds, and abrasions not more than 10 cm in length or 100 cm2 in total area) was compared with that of oral cephalexin in 2 randomized, double‑blind, double‑dummy clinical trials. Clinical efficacy rates at follow‑up in the per-protocol populations (adults and pediatric subjects included) were 96.1% for mupirocin cream (n = 231) and 93.1% for oral cephalexin (n = 219). Pathogen eradication rates at follow‑up in the per-protocol populations were 100% for both mupirocin cream and oral cephalexin." }

Pediatrics

{ "type": "p", "children": [], "text": "\nPediatrics\n" }

There were 93 pediatric subjects aged 2 weeks to 16 years enrolled per protocol in the secondarily infected skin lesion trials, although only 3 were younger than 2 years of age in the population treated with mupirocin cream. Subjects were randomized to either 10 days of topical mupirocin cream 3 times daily or 10 days of oral cephalexin (250 mg 4 times daily for subjects greater than 40 kg or 25 mg per kg per day oral suspension in 4 divided doses for subjects less than or equal to 40 kg). Clinical efficacy at follow‑up (7 to 12 days post-therapy) in the per-protocol populations was 97.7% (43 of 44) for mupirocin cream and 93.9% (46 of 49) for cephalexin.

{ "type": "p", "children": [], "text": "There were 93 pediatric subjects aged 2 weeks to 16 years enrolled per protocol in the secondarily infected skin lesion trials, although only 3 were younger than 2 years of age in the population treated with mupirocin cream. Subjects were randomized to either 10 days of topical mupirocin cream 3 times daily or 10 days of oral cephalexin (250 mg 4 times daily for subjects greater than 40 kg or 25 mg per kg per day oral suspension in 4 divided doses for subjects less than or equal to 40 kg). Clinical efficacy at follow‑up (7 to 12 days post-therapy) in the per-protocol populations was 97.7% (43 of 44) for mupirocin cream and 93.9% (46 of 49) for cephalexin." }

{ "type": "", "children": [], "text": "" }

Mupirocin cream USP, 2% is a white to off white cream that contains 20 mg (2% w/w) of mupirocin per gram in an oil-and water-based emulsion.

{ "type": "p", "children": [], "text": "\nMupirocin cream USP, 2% is a white to off white cream that contains 20 mg (2% w/w) of mupirocin per gram in an oil-and water-based emulsion." }

Mupirocin cream USP, 2% is supplied in 15-gram and 30-gram tubes.

{ "type": "p", "children": [], "text": "Mupirocin cream USP, 2% is supplied in 15-gram and 30-gram tubes." }

NDC 46708-624-15 (15-gram tube)

{ "type": "p", "children": [], "text": "NDC 46708-624-15 (15-gram tube)" }

NDC 46708-624-30 (30-gram tube)

{ "type": "p", "children": [], "text": "NDC 46708-624-30 (30-gram tube)" }

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Do not freeze.

{ "type": "p", "children": [], "text": "Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Do not freeze. " }

Advise the patient to read the FDA-approved patient labeling (Patient Information).

{ "type": "p", "children": [], "text": "\nAdvise the patient to read the FDA-approved patient labeling (Patient Information).\n" }

Advise the patient to administer mupirocin cream as follows:

{ "type": "p", "children": [], "text": "Advise the patient to administer mupirocin cream as follows:" }

{ "type": "ul", "children": [ "Use mupirocin cream only as directed by the healthcare provider. It is for external use only. Avoid contact of mupirocin cream with the eyes. If mupirocin cream gets in the eyes, rinse thoroughly with water.", "Do not use mupirocin cream in the nose.", "Wash your hands before and after applying mupirocin cream.", "Use a gauze pad or cotton swab to apply a small amount of mupirocin cream to the affected area. The treated area may be covered by gauze dressing if desired.", "Report to the healthcare provider any signs of local adverse reactions. mupirocin cream should be stopped and the healthcare provider contacted if irritation, severe itching, or rash occurs.", "Report to the healthcare provider or go to the nearest emergency room if severe allergic reactions, such as swelling of the lips, face, or tongue, or wheezing occur [see Warnings and Precautions (5.1)] .", "If no improvement is seen in 3 to 5 days, contact the healthcare provider." ], "text": "" }

Manufactured by:

{ "type": "p", "children": [], "text": "\nManufactured by:" }

Alembic Pharmaceuticals Limited

{ "type": "p", "children": [], "text": "\nAlembic Pharmaceuticals Limited\n" }

(Derma Division),

{ "type": "p", "children": [], "text": "(Derma Division)," }

Karakhadi, Vadodara 391450, India.

{ "type": "p", "children": [], "text": "Karakhadi, Vadodara 391450, India." }

Mfg. License No.: G/25/2216

{ "type": "p", "children": [], "text": "Mfg. License No.: G/25/2216" }

PHARMACIST-DETACH HERE AND GIVE INSTRUCTIONS TO PATIENT

{ "type": "p", "children": [], "text": "PHARMACIST-DETACH HERE AND GIVE INSTRUCTIONS TO PATIENT" }

--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

{ "type": "p", "children": [], "text": "--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------" }

<div class="scrollingtable"><table class="Noautorules" width="794"> <col width="369"/> <col width="425"/> <tbody class="Headless"> <tr> <td align="center" class="Botrule Lrule Rrule Toprule" colspan="2" valign="top"><span class="Bold"> PATIENT INFORMATION</span> <br/> <span class="Bold"> Mupirocin (mue-PIR-oh-sin)</span> <br/> <span class="Bold"> cream, for topical use</span> <br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" colspan="2" valign="top"><span class="Bold"> What is mupirocin cream?</span> <br/> Mupirocin cream is a prescription medicine used on the skin (topical use) to treat certain skin infections caused by bacteria called <span class="Italics">Staphylococcus aureus</span> and <span class="Italics">Streptococcus pyogenes</span> .<br/> It is not known if mupirocin cream is safe and effective in children under 3 months of age.<br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" colspan="2" valign="top"><span class="Bold"> Who should not use mupirocin cream?</span> <br/> <span class="Bold"> Do not use mupirocin cream if:</span> <br/> <ul class="Disc"> <li>you are allergic to mupirocin or any of the ingredients in mupirocin cream. See the end of this Patient Information leaflet for a complete list of the ingredients in mupirocin cream</li> </ul> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" colspan="2" valign="top"><span class="Bold"> What should I tell my healthcare provider before using mupirocin cream?</span> <br/> <span class="Bold"> Before using mupirocin cream, tell your healthcare provider about all of your medical conditions including if you:</span> <br/> <ul class="Disc"> <li>are pregnant or plan to become pregnant. It is not known if mupirocin cream will harm your unborn baby.</li> <li>are breastfeeding or plan to breastfeed. It is not known if mupirocin cream passes into your breast milk. You and your healthcare provider should decide if you can use mupirocin cream while breastfeeding.</li> </ul> <span class="Bold"> Tell your healthcare provider about all of the medicines you take,</span> including prescription and over-the-counter medicines, vitamins, and herbal supplements. Do not mix mupirocin cream with other lotions, creams, or ointments.<br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" colspan="2" valign="top"><span class="Bold"> How should I use mupirocin cream?</span> <br/> <ul class="Disc"> <li>Mupirocin cream is for use on the skin (topical). Do not get mupirocin cream in your eyes, nose, mouth, or vagina (mucosal surfaces).</li> <li>Use mupirocin cream exactly as your healthcare provider tells you to use it. </li> <li>Apply a small amount of mupirocin cream, with a cotton swab or gauze pad, to the affected area 3 times each day. Apply mupirocin cream for 10 days.</li> <li>It is important that you take the full course of mupirocin cream not stop early because your symptoms may disappear before the infection is fully cleared.</li> <li>Wash your hands before and after applying mupirocin cream.</li> <li>After applying mupirocin cream, you may cover the treated area with a clean gauze pad, unless your healthcare provider has told you to leave it uncovered.</li> <li>Talk to your healthcare provider if your skin does not improve after 3 to 5 days of treatment with mupirocin cream.</li> <li>If you are breastfeeding and use mupirocin cream on your breast or nipple, wash the area well before breastfeeding your child.</li> </ul> </td> </tr> <tr> <td align="left" class="Lrule Rrule" colspan="2" valign="top"><span class="Bold"> What are the possible side effects of mupirocin cream?</span> <br/> <span class="Bold"> Mupirocin cream may cause serious side effects, including: </span> <br/> <ul class="Disc"> <li> <span class="Bold"> severe allergic reactions</span> . Stop using mupirocin cream and call your healthcare provider or go to the nearest emergency room right away if you have any of the following signs or symptoms of a severe allergic reaction:</li> </ul> </td> </tr> <tr> <td align="left" class="Lrule" valign="top">               ○  hives<br/> </td><td align="left" class="Rrule" valign="top">    ○  trouble breathing or wheezing<br/> </td> </tr> <tr> <td align="left" class="Lrule" valign="top">               ○  swelling of your face, lips, mouth, or tongue  <br/> </td><td align="left" class="Rrule" valign="top">    ○  dizziness, fast heartbeat, or pounding in your chest<br/> </td> </tr> <tr> <td align="left" class="Lrule" valign="top">               ○  a rash over your whole body   <br/> </td><td class="Rrule" valign="top"></td> </tr> <tr> <td class="Lrule Rrule" colspan="2" valign="top"> <ul class="Disc"> <li> <span class="Bold"> eye irritation</span> . Do not get mupirocin cream in your eyes. If mupirocin cream gets in your eyes, rinse your eyes well with water.</li> <li> <span class="Bold"> irritation in the area mupirocin cream is used</span> . A rash may occur after using mupirocin cream and can be severe. Stop using mupirocin cream and call your healthcare provider if you develop an irritation, severe itching, or a rash while using mupirocin cream.</li> <li> <span class="Bold"> a type of diarrhea called <span class="Italics">clostridium difficile</span> -associated diarrhea (CDAD).</span> CDAD may happen in people who use or have used medicine to treat bacterial infections. The severity of CDAD can range from mild diarrhea to severe diarrhea that may cause death (fatal colitis). Call your healthcare provider or go to the nearest emergency room right away if you have diarrhea while using or after you stop using mupirocin cream.</li> </ul> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" colspan="2" valign="top"> The most common side effects of mupirocin cream include:<br/> <ul class="Disc"> <li>headache</li> <li>rash</li> <li>nausea</li> </ul> These are not all the possible side effects of mupirocin cream. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.<br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" colspan="2" valign="top"><span class="Bold"> How should I store mupirocin cream?</span> <br/> <ul class="Disc"> <li>Store mupirocin cream at room temperature between 68°F to 77°F (20°C to 25°C). </li> <li>Do not freeze mupirocin cream.</li> <li> <span class="Bold"> Keep mupirocin cream and all medicines out of the reach of children.</span> </li> </ul> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" colspan="2" valign="top"><span class="Bold"> General information about the safe and effective use of mupirocin cream.</span> <br/> Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use mupirocin cream for a condition for which it was not prescribed. Do not give mupirocin cream to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about mupirocin cream that is written for health professionals.<br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" colspan="2" valign="top"><span class="Bold"> What are the ingredients in mupirocin cream?</span> <br/> <span class="Bold"> Active Ingredient:</span> mupirocin calcium<br/> <span class="Bold"> Inactive Ingredients:</span> benzyl alcohol, glycerol monostearate, mineral oil, phenoxyethanol, polyoxyl 20 cetostearyl ether, purified water, and xanthan gum.<br/> Manufactured by:<br/> <span class="Bold"> Alembic Pharmaceuticals Limited</span> <br/> (Derma Division),<br/> Karakhadi, Vadodara 391450, India.<br/> Mfg. License No.: G/25/2216<br/> For more information, call 1-866-210-9797<br/> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table class=\"Noautorules\" width=\"794\">\n<col width=\"369\"/>\n<col width=\"425\"/>\n<tbody class=\"Headless\">\n<tr>\n<td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" colspan=\"2\" valign=\"top\"><span class=\"Bold\"> PATIENT INFORMATION</span>\n<br/>\n<span class=\"Bold\"> Mupirocin (mue-PIR-oh-sin)</span>\n<br/>\n<span class=\"Bold\"> cream, for topical use</span>\n<br/>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\"><span class=\"Bold\"> What is mupirocin cream?</span>\n<br/> Mupirocin cream is a prescription medicine used on the skin (topical use) to treat certain skin infections caused by bacteria called <span class=\"Italics\">Staphylococcus aureus</span> and <span class=\"Italics\">Streptococcus pyogenes</span> .<br/> It is not known if mupirocin cream is safe and effective in children under 3 months of age.<br/>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\"><span class=\"Bold\"> Who should not use mupirocin cream?</span>\n<br/>\n<span class=\"Bold\"> Do not use mupirocin cream if:</span>\n<br/>\n<ul class=\"Disc\">\n<li>you are allergic to mupirocin or any of the ingredients in mupirocin cream. See the end of this Patient Information leaflet for a complete list of the ingredients in mupirocin cream</li>\n</ul>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\"><span class=\"Bold\"> What should I tell my healthcare provider before using mupirocin cream?</span>\n<br/>\n<span class=\"Bold\"> Before using mupirocin cream, tell your healthcare provider about all of your medical conditions including if you:</span>\n<br/>\n<ul class=\"Disc\">\n<li>are pregnant or plan to become pregnant. It is not known if mupirocin cream will harm your unborn baby.</li>\n<li>are breastfeeding or plan to breastfeed. It is not known if mupirocin cream passes into your breast milk. You and your healthcare provider should decide if you can use mupirocin cream while breastfeeding.</li>\n</ul>\n<span class=\"Bold\"> Tell your healthcare provider about all of the medicines you take,</span> including prescription and over-the-counter medicines, vitamins, and herbal supplements. Do not mix mupirocin cream with other lotions, creams, or ointments.<br/>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\"><span class=\"Bold\"> How should I use mupirocin cream?</span>\n<br/>\n<ul class=\"Disc\">\n<li>Mupirocin cream is for use on the skin (topical). Do not get mupirocin cream in your eyes, nose, mouth, or vagina (mucosal surfaces).</li>\n<li>Use mupirocin cream exactly as your healthcare provider tells you to use it. </li>\n<li>Apply a small amount of mupirocin cream, with a cotton swab or gauze pad, to the affected area 3 times each day. Apply mupirocin cream for 10 days.</li>\n<li>It is important that you take the full course of mupirocin cream not stop early because your symptoms may disappear before the infection is fully cleared.</li>\n<li>Wash your hands before and after applying mupirocin cream.</li>\n<li>After applying mupirocin cream, you may cover the treated area with a clean gauze pad, unless your healthcare provider has told you to leave it uncovered.</li>\n<li>Talk to your healthcare provider if your skin does not improve after 3 to 5 days of treatment with mupirocin cream.</li>\n<li>If you are breastfeeding and use mupirocin cream on your breast or nipple, wash the area well before breastfeeding your child.</li>\n</ul>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Lrule Rrule\" colspan=\"2\" valign=\"top\"><span class=\"Bold\"> What are the possible side effects of mupirocin cream?</span>\n<br/>\n<span class=\"Bold\"> Mupirocin cream may cause serious side effects, including: </span>\n<br/>\n<ul class=\"Disc\">\n<li>\n<span class=\"Bold\"> severe allergic reactions</span> . Stop using mupirocin cream and call your healthcare provider or go to the nearest emergency room right away if you have any of the following signs or symptoms of a severe allergic reaction:</li>\n</ul>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Lrule\" valign=\"top\">               ○  hives<br/>\n</td><td align=\"left\" class=\"Rrule\" valign=\"top\">    ○  trouble breathing or wheezing<br/>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Lrule\" valign=\"top\">               ○  swelling of your face, lips, mouth, or tongue  <br/>\n</td><td align=\"left\" class=\"Rrule\" valign=\"top\">    ○  dizziness, fast heartbeat, or pounding in your chest<br/>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Lrule\" valign=\"top\">               ○  a rash over your whole body   <br/>\n</td><td class=\"Rrule\" valign=\"top\"></td>\n</tr>\n<tr>\n<td class=\"Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<ul class=\"Disc\">\n<li>\n<span class=\"Bold\"> eye irritation</span> . Do not get mupirocin cream in your eyes. If mupirocin cream gets in your eyes, rinse your eyes well with water.</li>\n<li>\n<span class=\"Bold\"> irritation in the area mupirocin cream is used</span> . A rash may occur after using mupirocin cream and can be severe. Stop using mupirocin cream and call your healthcare provider if you develop an irritation, severe itching, or a rash while using mupirocin cream.</li>\n<li>\n<span class=\"Bold\"> a type of diarrhea called <span class=\"Italics\">clostridium difficile</span> -associated diarrhea (CDAD).</span> CDAD may happen in people who use or have used medicine to treat bacterial infections. The severity of CDAD can range from mild diarrhea to severe diarrhea that may cause death (fatal colitis). Call your healthcare provider or go to the nearest emergency room right away if you have diarrhea while using or after you stop using mupirocin cream.</li>\n</ul>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\"> The most common side effects of mupirocin cream include:<br/>\n<ul class=\"Disc\">\n<li>headache</li>\n<li>rash</li>\n<li>nausea</li>\n</ul>\n These are not all the possible side effects of mupirocin cream. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.<br/>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\"><span class=\"Bold\"> How should I store mupirocin cream?</span>\n<br/>\n<ul class=\"Disc\">\n<li>Store mupirocin cream at room temperature between 68°F to 77°F (20°C to 25°C). </li>\n<li>Do not freeze mupirocin cream.</li>\n<li>\n<span class=\"Bold\"> Keep mupirocin cream and all medicines out of the reach of children.</span>\n</li>\n</ul>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\"><span class=\"Bold\"> General information about the safe and effective use of mupirocin cream.</span>\n<br/> Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use mupirocin cream for a condition for which it was not prescribed. Do not give mupirocin cream to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about mupirocin cream that is written for health professionals.<br/>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\"><span class=\"Bold\"> What are the ingredients in mupirocin cream?</span>\n<br/>\n<span class=\"Bold\"> Active Ingredient:</span> mupirocin calcium<br/>\n<span class=\"Bold\"> Inactive Ingredients:</span> benzyl alcohol, glycerol monostearate, mineral oil, phenoxyethanol, polyoxyl 20 cetostearyl ether, purified water, and xanthan gum.<br/> Manufactured by:<br/>\n<span class=\"Bold\"> Alembic Pharmaceuticals Limited</span>\n<br/> (Derma Division),<br/> Karakhadi, Vadodara 391450, India.<br/> Mfg. License No.: G/25/2216<br/> For more information, call 1-866-210-9797<br/>\n</td>\n</tr>\n</tbody>\n</table></div>" }

This Patient Information has been approved by the U.S. Food and Drug Administration    Revised: 03/2025

{ "type": "p", "children": [], "text": "\nThis Patient Information has been approved by the U.S. Food and Drug Administration    Revised: 03/2025" }

15 gram Tube label

{ "type": "p", "children": [], "text": "\n15 gram Tube label\n" }

NDC 46708-624-15

{ "type": "p", "children": [], "text": "\nNDC 46708-624-15 \n" }

15 grams

{ "type": "p", "children": [], "text": "\n15 grams\n" }

Mupirocin Cream USP, 2%

{ "type": "p", "children": [], "text": "\nMupirocin Cream USP, 2%\n" }

15 gram Carton label

{ "type": "p", "children": [], "text": "\n15 gram Carton label\n" }

NDC 46708-624-15

{ "type": "p", "children": [], "text": "\nNDC 46708-624-15 \n" }

15 grams

{ "type": "p", "children": [], "text": "\n15 grams\n" }

Mupirocin Cream USP, 2%

{ "type": "p", "children": [], "text": "\nMupirocin Cream USP, 2%\n" }

Mupirocin ointment is indicated for the topical treatment of impetigo due to susceptible isolates of Staphylococcus aureus (S. aureus) and Streptococcus pyogenes (S. pyogenes).

{ "type": "p", "children": [], "text": "Mupirocin ointment is indicated for the topical treatment of impetigo due to susceptible isolates of \n Staphylococcus aureus (S. aureus) and \n Streptococcus pyogenes (S. pyogenes).\n" }

{ "type": "ul", "children": [ "For Topical Use Only.", "Apply a small amount of mupirocin ointment, with a cotton swab or gauze pad, to the affected area 3 times daily for up to 10 days.", "Cover the treated area with gauze dressing if desired.", "Re-evaluate patients not showing a clinical response within 3 to 5 days.", "Mupirocin ointment is not for intranasal, ophthalmic, or other mucosal use \n [see Warnings and Precautions (5.2, 5.6)] .\n ", "Do not apply mupirocin ointment concurrently with any other lotions, creams, or ointments \n [see Clinical Pharmacology (12.3)]. \n" ], "text": "" }

Each gram of Mupirocin Ointment, USP 2% contains 20 mg mupirocin in a water-miscible ointment base supplied in 1-gram tubes.

{ "type": "p", "children": [], "text": "Each gram of Mupirocin Ointment, USP 2% contains 20 mg mupirocin in a water-miscible ointment base supplied in 1-gram tubes." }

Mupirocin ointment is contraindicated in patients with known hypersensitivity to mupirocin or any of the excipients of mupirocin ointment.

{ "type": "p", "children": [], "text": "Mupirocin ointment is contraindicated in patients with known hypersensitivity to mupirocin or any of the excipients of mupirocin ointment." }

Avoid contact with the eyes. In case of accidental contact, rinse well with water.

In the event of a sensitization or severe local irritation from mupirocin ointment, usage should be discontinued, and appropriate alternative therapy for the infection instituted.

Clostridium difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.

C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin-producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibacterial drug use. Careful medical history is necessary since CDAD has been reported to occur over 2 months after the administration of antibacterial agents.

If CDAD is suspected or confirmed, ongoing antibacterial drug use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibacterial treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.

As with other antibacterial products, prolonged use of mupirocin ointment may result in overgrowth of nonsusceptible microorganisms, including fungi [see Dosage and Administration (2)].

Mupirocin ointment is not formulated for use on mucosal surfaces. Intranasal use has been associated with isolated reports of stinging and drying. A separate formulation, mupirocin nasal ointment, is available for intranasal use.

Polyethylene glycol can be absorbed from open wounds and damaged skin and is excreted by the kidneys. In common with other polyethylene glycol-based ointments, mupirocin ointment should not be used in conditions where absorption of large quantities of polyethylene glycol is possible, especially if there is evidence of moderate or severe renal impairment.

Mupirocin ointment should not be used with intravenous cannulae or at central intravenous sites because of the potential to promote fungal infections and antimicrobial resistance.

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The following local adverse reactions were reported by at least 1% of subjects in connection with the use of mupirocin ointment in clinical trials: burning, stinging, or pain in 1.5% of subjects; itching in 1% of subjects. Rash, nausea, erythema, dry skin, tenderness, swelling, contact dermatitis, and increased exudate were reported in less than 1% of subjects.

In addition to adverse reactions reported from clinical trials, the following reactions have been identified during postmarketing use of mupirocin ointment. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These reactions have been chosen for inclusion due to a combination of their seriousness, frequency of reporting, or potential causal relationship to mupirocin ointment.

Immune System Disorders

Systemic allergic reactions, including anaphylaxis, urticaria, angioedema, and generalized rash [see Warnings and Precautions ( 5.1)] .

Risk Summary

There are insufficient human data to establish whether there is a drug-associated risk with mupirocin ointment in pregnant women. Systemic absorption of mupirocin through intact human skin is minimal following topical administration of mupirocin ointment [see Clinical Pharmacology ( 12.3)] . No developmental toxicity was observed in rats or rabbits treated with mupirocin subcutaneously during organogenesis at doses of 160 mg per kg per day or 40 mg per kg per day, respectively (22 and 11 times the human topical dose based on calculations of dose divided by the entire body surface area).

The estimated background risk of major birth defects and miscarriages for the indicated population is unknown. The estimated background risk in the U.S. general population of major birth defects is 2% to 4% and of miscarriage is 15% to 20% of clinically recognized pregnancies.

Data

Animal Data:Developmental toxicity studies have been performed with mupirocin administered subcutaneously to rats and rabbits at doses up to 160 mg per kg per day during organogenesis. This dose is 22 and 43 times, respectively, the human topical dose (approximately 60 mg mupirocin per day) based on calculations of dose divided by the entire body surface area. Maternal toxicity was observed (body weight loss/decreased body weight gain and reduced feeding) in both species with no evidence of developmental toxicity in rats. In rabbits, excessive maternal toxicity at the high dose precluded the evaluation of fetal outcomes. There was no developmental toxicity in rabbits at 40 mg per kg per day, 11 times the human topical dose based on calculations of dose divided by the entire body surface area.

Mupirocin administered subcutaneously to rats in a pre-and postnatal development study (dosed during late gestation through lactation) was associated with reduced offspring viability in the early postnatal period at a dose of 106.7 mg per kg, in the presence of injection site irritation and/or subcutaneous hemorrhaging. This dose is 14 times the human topical dose based on calculations of dose divided by the entire body surface area. The no-observed adverse effect level in this study was 44.2 mg per kg per day, which is 6 times the human topical dose.

Risk Summary

It is not known whether mupirocin is present in human milk, has effects on the breastfed child, or has effects on milk production. However, breastfeeding is not expected to result in exposure of the child to the drug due to the minimal systemic absorption of mupirocin in humans following topical administration of mupirocin ointment [see Clinical Pharmacology ( 12.3)] . The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for mupirocin ointment and any potential adverse effects on the breastfed child from mupirocin ointment or from the underlying maternal condition.

Clinical Considerations

To minimize oral exposure of the drug to children, a breast and/or nipple being treated with mupirocin ointment should be thoroughly washed prior to breastfeeding.

The safety and effectiveness of mupirocin ointment have been established in the age range of 2 months to 16 years. Use of mupirocin ointment in these age-groups is supported by evidence from adequate and well-controlled trials of mupirocin ointment in impetigo in pediatric subjects studied as a part of the pivotal clinical trials [see Clinical Studies ( 14)] .

Mupirocin Ointment USP, 2% contains the RNA synthetase inhibitor antibacterial, mupirocin. The chemical name is ( E)-(2 S,3 R,4 R,5 S)-5-[(2 S,3 S,4 S,5 S)-2,3-epoxy-5-hydroxy-4-methylhexyl]tetrahydro-3,4dihydroxy-β-methyl-2 H-pyran-2-crotonic acid, ester with 9-hydroxynonanoic acid. The molecular formula of mupirocin, USP is C 26H 44O 9, and the molecular weight is 500.6.

{ "type": "p", "children": [], "text": "Mupirocin Ointment USP, 2% contains the RNA synthetase inhibitor antibacterial, mupirocin. The chemical name is ( \n E)-(2 \n S,3 \n R,4 \n R,5 \n S)-5-[(2 \n S,3 \n S,4 \n S,5 \n S)-2,3-epoxy-5-hydroxy-4-methylhexyl]tetrahydro-3,4dihydroxy-β-methyl-2 \n H-pyran-2-crotonic acid, ester with 9-hydroxynonanoic acid. The molecular formula of mupirocin, USP is C\n 26H\n 44O\n 9, and the molecular weight is 500.6.\n " }

The structural formula of mupirocin is:

{ "type": "p", "children": [], "text": "The structural formula of mupirocin is:" }

Each gram of Mupirocin Ointment USP, 2% contains 20 mg mupirocin in a water-miscible ointment base (polyethylene glycol ointment, NF) consisting of polyethylene glycol 400 and polyethylene glycol 3350.

{ "type": "p", "children": [], "text": "Each gram of Mupirocin Ointment USP, 2% contains 20 mg mupirocin in a water-miscible ointment base (polyethylene glycol ointment, NF) consisting of polyethylene glycol 400 and polyethylene glycol 3350." }

Mupirocin is an RNA synthetase inhibitor antibacterial [see Microbiology ( 12.4)].

Absorption

Application of 14C-labeled mupirocin ointment to the lower arm of normal male subjects followed by occlusion for 24 hours showed no measurable systemic absorption (less than 1.1 nanogram mupirocin per milliliter of whole blood). Measurable radioactivity was present in the stratum corneum of these subjects 72 hours after application. The effect of the concurrent application of mupirocin ointment with other topical products has not been studied [see Dosage and Administration ( 2)] .

Elimination

In a trial conducted in 7 healthy adult male subjects, the elimination half-life after intravenous administration of mupirocin was 20 to 40 minutes for mupirocin and 30 to 80 minutes for monic acid.

Metabolism: Following intravenous or oral administration, mupirocin is rapidly metabolized. The principal metabolite, monic acid, demonstrates no antibacterial activity.

Excretion: Monic acid is predominantly eliminated by renal excretion.

Mupirocin is an RNA synthetase inhibitor antibacterial produced by fermentation using the organism Pseudomonas fluorescens.

Mechanism of Action

Mupirocin inhibits bacterial protein synthesis by reversibly and specifically binding to bacterial isoleucyl-transfer RNA (tRNA) synthetase.

Mupirocin is bactericidal at concentrations achieved by topical administration. Mupirocin is highly protein bound (greater than 97%) and the effect of wound secretions on the minimum inhibitory concentrations (MICs) of mupirocin has not been determined.

Resistance

When mupirocin resistance occurs, it results from the production of a modified isoleucyl-tRNA synthetase, or the acquisition of, by genetic transfer, a plasmid mediating a new isoleucyl-tRNA synthetase. High-level plasmid-mediated resistance (MIC ≥512 mcg/mL) has been reported in increasing numbers of isolates of S. aureus and with higher frequency in coagulase-negative staphylococci. Mupirocin resistance occurs with greater frequency in methicillin-resistant than methicillin-susceptible staphylococci.

Cross Resistance

Due to its mode of action, mupirocin does not demonstrate cross resistance with other classes of antimicrobial agents.

Antimicrobial Activity

Mupirocin has been shown to be active against susceptible isolates of S. aureus and S. pyogenes, both in vitro and in clinical trials [see Indications and Usage ( 1)]. The following in vitro data are available, but their clinical significance is unknown. Mupirocin is active against most isolates of Staphylococcus epidermidis.

Susceptibility Test Methods

High-level mupirocin resistance (≥512 mcg/mL) may be determined using standard disk diffusion or broth microdilution tests. 1,2 Because of the occurrence of mupirocin resistance in methicillin-resistant S. aureus (MRSA), it is appropriate to test MRSA populations for mupirocin susceptibility prior to the use of mupirocin using a standardized method. 3,4,5

Long-term studies in animals to evaluate carcinogenic potential of mupirocin have not been conducted.

Results of the following studies performed with mupirocin calcium or mupirocin sodium in vitro and in vivo did not indicate a potential for genotoxicity: rat primary hepatocyte unscheduled DNA synthesis, sediment analysis for DNA strand breaks, Salmonella reversion test (Ames), Escherichia coli mutation assay, metaphase analysis of human lymphocytes, mouse lymphoma assay, and bone marrow micronuclei assay in mice.

In a fertility/reproductive performance study (with dosing through lactation), mupirocin administered subcutaneously to male and female rats at doses up to 100 mg per kg per day which is 14 times the human topical dose (approximately 60 mg mupirocin per day) based on calculations of dose divided by the entire body surface area, did not result in impaired fertility or impaired reproductive performance attributable to mupirocin.

The efficacy of topical mupirocin ointment in impetigo was tested in 2 trials. In the first, subjects with impetigo were randomized to receive either mupirocin ointment or vehicle placebo 3 times daily for 8 to 12 days. Clinical efficacy rates at end of therapy in the evaluable populations (adults and pediatric subjects included) were 71% for mupirocin ointment (n = 49) and 35% for vehicle placebo (n = 51). Pathogen eradication rates in the evaluable populations were 94% for mupirocin ointment and 62% for vehicle placebo.

{ "type": "p", "children": [], "text": "The efficacy of topical mupirocin ointment in impetigo was tested in 2 trials. In the first, subjects with impetigo were randomized to receive either mupirocin ointment or vehicle placebo 3 times daily for 8 to 12 days. Clinical efficacy rates at end of therapy in the evaluable populations (adults and pediatric subjects included) were 71% for mupirocin ointment (n = 49) and 35% for vehicle placebo (n = 51). Pathogen eradication rates in the evaluable populations were 94% for mupirocin ointment and 62% for vehicle placebo." }

In the second trial, subjects with impetigo were randomized to receive either mupirocin ointment 3 times daily or 30 mg per kg to 40 mg per kg oral erythromycin ethylsuccinate per day (this was an unblinded trial) for 8 days. There was a follow-up visit 1 week after treatment ended. Clinical efficacy rates at the follow-up visit in the evaluable populations (adults and pediatric subjects included) were 93% for mupirocin ointment (n = 29) and 78.5% for erythromycin (n = 28). Pathogen eradication rates in the evaluable populations were 100% for both test groups.

{ "type": "p", "children": [], "text": "In the second trial, subjects with impetigo were randomized to receive either mupirocin ointment 3 times daily or 30 mg per kg to 40 mg per kg oral erythromycin ethylsuccinate per day (this was an unblinded trial) for 8 days. There was a follow-up visit 1 week after treatment ended. Clinical efficacy rates at the follow-up visit in the evaluable populations (adults and pediatric subjects included) were 93% for mupirocin ointment (n = 29) and 78.5% for erythromycin (n = 28). Pathogen eradication rates in the evaluable populations were 100% for both test groups." }

Pediatrics

{ "type": "p", "children": [], "text": "\nPediatrics\n" }

There were 91 pediatric subjects aged 2 months to 15 years in the first trial described above. Clinical efficacy rates at end of therapy in the evaluable populations were 78% for mupirocin ointment (n = 42) and 36% for vehicle placebo (n = 49). In the second trial described above, all subjects were pediatric except 2 adults in the group receiving mupirocin ointment. The age range of the pediatric subjects was 7 months to 13 years. The clinical efficacy rate for mupirocin ointment (n = 27) was 96%, and for erythromycin it was unchanged (78.5%).

{ "type": "p", "children": [], "text": "There were 91 pediatric subjects aged 2 months to 15 years in the first trial described above. Clinical efficacy rates at end of therapy in the evaluable populations were 78% for mupirocin ointment (n = 42) and 36% for vehicle placebo (n = 49). In the second trial described above, all subjects were pediatric except 2 adults in the group receiving mupirocin ointment. The age range of the pediatric subjects was 7 months to 13 years. The clinical efficacy rate for mupirocin ointment (n = 27) was 96%, and for erythromycin it was unchanged (78.5%)." }

{ "type": "", "children": [], "text": "" }

Each gram of Mupirocin Ointment USP 2% contains 20 mg mupirocin in a water-miscible ointment base.

{ "type": "p", "children": [], "text": "Each gram of Mupirocin Ointment USP 2% contains 20 mg mupirocin in a water-miscible ointment base." }

Mupirocin Ointment USP, 2% is supplied as follows:

{ "type": "p", "children": [], "text": "Mupirocin Ointment USP, 2% is supplied as follows:" }

NDC 81033-032-01: 1-gram tube

{ "type": "p", "children": [], "text": "NDC 81033-032-01: 1-gram tube" }

NDC 81033-032-50: Box of 50 (1-gram tubes)

{ "type": "p", "children": [], "text": "NDC 81033-032-50: Box of 50 (1-gram tubes)" }

NDC 81033-032-99: Box of 100 (1-gram tubes)

{ "type": "p", "children": [], "text": "NDC 81033-032-99: Box of 100 (1-gram tubes)" }

Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature].

{ "type": "p", "children": [], "text": "Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]." }

Advise the patient to read the FDA-approved patient labeling (Patient Information). Advise the patient to administer mupirocin ointment as follows:

{ "type": "p", "children": [], "text": "\nAdvise the patient to read the FDA-approved patient labeling (Patient Information).\n\n\nAdvise the patient to administer mupirocin ointment as follows:\n " }

{ "type": "ul", "children": [ "Use mupirocin ointment only as directed by the healthcare provider. It is for external use only. Avoid contact of mupirocin ointment with the eyes. If mupirocin ointment gets in the eyes, rinse thoroughly with water.", "Do not use mupirocin ointment in the nose.", "Wash your hands before and after applying mupirocin ointment.", "Use a gauze pad or cotton swab to apply a small amount of mupirocin ointment to the affected area. The treated area may be covered by gauze dressing if desired.", "Report to the healthcare provider any signs of local adverse reactions. Mupirocin ointment should be stopped and the healthcare provider contacted if irritation, severe itching, or rash occurs.", "Report to the healthcare provider or go to the nearest emergency room if severe allergic reactions, such as swelling of the lips, face, or tongue, or wheezing occur \n [see Warnings and Precautions (5.1)].\n ", "If impetigo has not improved in 3 to 5 days, contact the healthcare provider." ], "text": "" }

Distributed by: Kesin Pharma Oldsmar, FL 34677 Revised : June 2025 V01

{ "type": "p", "children": [], "text": "Distributed by:\n \nKesin Pharma\n\nOldsmar, FL 34677\n \nRevised : June 2025\n \nV01\n " }

<div class="scrollingtable"><table border="0" width="100%"> <tbody class="Headless"> <tr class="First"> <td><span class="Bold">Mupirocin (mue-PIR-oh-sin) Ointment</span></td> </tr> <tr> <td><span class="Bold">What is mupirocin ointment? </span> <br/> Mupirocin ointment is a prescription medicine used on the skin (topical use) to treat a skin infection called impetigo that is caused by bacteria called <span class="Bold">Staphylococcus aureus</span> and <span class="Bold">Streptococcus pyogenes</span>. <br/> It is not known if mupirocin ointment is safe and effective in children under 2 months of age. </td> </tr> <tr> <td><span class="Bold">Who should not use mupirocin ointment? <br/> Do not use mupirocin ointment if: </span> <br/> • you are allergic to mupirocin or any of the ingredients in mupirocin ointment. See the end of this Patient Information leaflet for a complete list of the ingredients in mupirocin ointment. </td> </tr> <tr> <td><span class="Bold">What should I tell my healthcare provider before using mupirocin ointment? <br/> Before using mupirocin ointment, tell your healthcare provider about all of your medical conditions including if you: </span> <br/> • have kidney problems <br/> • are pregnant or plan to become pregnant. It is not known if mupirocin ointment will harm your unborn baby. <br/> • are breastfeeding or plan to breastfeed. It is not known if mupirocin ointment passes into your breast milk. You and your healthcare provider should decide if you can use mupirocin ointment while breastfeeding. </td> </tr> <tr> <td><span class="Bold">Tell your healthcare provider about all of the medicines you take, </span>including prescription and over-the-counter medicines, vitamins, and herbal supplements. <br/> Do not mix mupirocin ointment with other lotions, creams, or ointments. </td> </tr> <tr> <td><span class="Bold">How should I use mupirocin ointment? <br/> • Mupirocin ointment is for use on the skin (topical).  </span>Do not get mupirocin ointment in your eyes, nose, mouth, or vagina (mucosal surfaces). <br/> • Use mupirocin ointment exactly as your healthcare provider tells you to use it. <br/> • Apply a small amount of mupirocin ointment, with a cotton swab or gauze pad, to the affected area 3 times each day. <br/> • It is important that you take the full course of mupirocin ointment. Do not stop early because your symptoms may disappear before the infection is fully cleared. <br/> • Wash your hands  <span class="Bold">before and after</span> applying mupirocin ointment. <br/> • After applying mupirocin ointment, you may cover the treated area with a clean gauze pad, unless your healthcare provider has told you to leave it uncovered. <br/> • Talk to your healthcare provider if your skin does not improve after 3 to 5 days of treatment with mupirocin ointment. <br/> • If you are breastfeeding and use mupirocin ointment on your breast or nipple, wash the area well before breastfeeding your child. </td> </tr> <tr> <td><span class="Bold">What are the possible side effects of mupirocin ointment? </span> <br/> Mupirocin ointment may cause serious side effects, including: <br/> <span class="Bold">• severe allergic reactions.</span> Stop using mupirocin ointment and call your healthcare provider or go to the nearest emergency room right away if you have any of the following signs or symptoms of a severe allergic reaction: <br/> • hives • trouble breathing or wheezing <br/> • swelling of your face, lips, mouth, or tongue • dizziness, fast heartbeat or pounding in your chest <br/> • a rash over your whole body <br/> <span class="Bold">• eye irritation.</span> Do not get mupirocin ointment in your eyes. If mupirocin ointment gets in your eyes, rinse your eyes well with water. <br/> <span class="Bold">• irritation in the area mupirocin ointment is used.</span> Stop using mupirocin ointment and call your healthcare provider if you develop an irritation, severe itching, or a rash while using mupirocin ointment. <br/> <span class="Bold">• a type of diarrhea called clostridium difficile-associated diarrhea (CDAD).</span> CDAD may happen in people who use or have used medicine to treat bacterial infections. The severity of CDAD can range from mild diarrhea to severe diarrhea that may cause death (fatal colitis). Call your healthcare provider or go to the nearest emergency room right away if you have diarrhea while using or after you stop using mupirocin ointment. <br/> <span class="Bold">• risk of absorption of polyethylene glycol through the skin. </span>Mupirocin ointment contains polyethylene glycol, which in large amounts can cause kidney damage. You should not apply mupirocin ointment to open skin wounds or damaged skin, especially if you have kidney problems. <br/> <span class="Bold">• increased risk of infection at IV (intravenous) sites.</span> Mupirocin ointment should not be used on skin that is near an IV (intravenous) site. <br/> The most common side effects of mupirocin ointment include: <br/> • burning <br/> • stinging or pain <br/> • itching <br/> These are not all the possible side effects of mupirocin ointment. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. </td> </tr> <tr> <td><span class="Bold">How should I store mupirocin ointment? </span> <br/> Store mupirocin ointment at room temperature between 68°F to 77°F (20°C to 25°C). <br/> <span class="Bold">Keep mupirocin ointment and all medicines out of the reach of children.</span></td> </tr> <tr> <td><span class="Bold">General information about the safe and effective use of mupirocin ointment </span> <br/> Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use mupirocin ointment for a condition for which it was not prescribed. Do not give mupirocin ointment to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about mupirocin ointment that is written for health professionals. </td> </tr> <tr class="Last"> <td><span class="Bold">What are the ingredients in mupirocin ointment? </span> <br/> <span class="Bold">Active Ingredient:</span> mupirocin <br/> <span class="Bold">Inactive Ingredients:</span> polyethylene glycol 400 and polyethylene glycol 3350 <br/> For more information, call 1-833-537-4679 </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table border=\"0\" width=\"100%\">\n<tbody class=\"Headless\">\n<tr class=\"First\">\n<td><span class=\"Bold\">Mupirocin (mue-PIR-oh-sin) Ointment</span></td>\n</tr>\n<tr>\n<td><span class=\"Bold\">What is mupirocin ointment? </span>\n<br/>\n\t\t\tMupirocin ointment is a prescription medicine used on the skin (topical use) to treat a skin infection called impetigo that is caused by bacteria called \n <span class=\"Bold\">Staphylococcus aureus</span> and \n <span class=\"Bold\">Streptococcus pyogenes</span>.\n <br/>\n\t\t\tIt is not known if mupirocin ointment is safe and effective in children under 2 months of age.\n </td>\n</tr>\n<tr>\n<td><span class=\"Bold\">Who should not use mupirocin ointment?\n <br/>\n\t\t\tDo not use mupirocin ointment if: \n </span>\n<br/>\n\t\t\t• you are allergic to mupirocin or any of the ingredients in mupirocin ointment. See the end of this Patient Information leaflet for a complete list of the ingredients in mupirocin ointment.\n </td>\n</tr>\n<tr>\n<td><span class=\"Bold\">What should I tell my healthcare provider before using mupirocin ointment?\n <br/>\n\t\t\tBefore using mupirocin ointment, tell your healthcare provider about all of your medical conditions including if you: \n </span>\n<br/>\n\t\t\t• have kidney problems\n <br/>\n\t\t\t• are pregnant or plan to become pregnant. It is not known if mupirocin ointment will harm your unborn baby.\n <br/>\n\t\t\t• are breastfeeding or plan to breastfeed. It is not known if mupirocin ointment passes into your breast milk. You and your healthcare provider should decide if you can use mupirocin ointment while breastfeeding.\n </td>\n</tr>\n<tr>\n<td><span class=\"Bold\">Tell your healthcare provider about all of the medicines you take, </span>including prescription and over-the-counter medicines, vitamins, and herbal supplements.\n <br/>\n\t\t\tDo not mix mupirocin ointment with other lotions, creams, or ointments.\n </td>\n</tr>\n<tr>\n<td><span class=\"Bold\">How should I use mupirocin ointment?\n <br/>\n\t\t\t• Mupirocin ointment is for use on the skin (topical). \n </span>Do not get mupirocin ointment in your eyes, nose, mouth, or vagina (mucosal surfaces).\n <br/>\n\t\t\t• Use mupirocin ointment exactly as your healthcare provider tells you to use it.\n <br/>\n\t\t\t• Apply a small amount of mupirocin ointment, with a cotton swab or gauze pad, to the affected area 3 times each day.\n <br/>\n\t\t\t• It is important that you take the full course of mupirocin ointment. Do not stop early because your symptoms may disappear before the infection is fully cleared.\n <br/>\n\t\t\t• Wash your hands \n <span class=\"Bold\">before and after</span> applying mupirocin ointment.\n <br/>\n\t\t\t• After applying mupirocin ointment, you may cover the treated area with a clean gauze pad, unless your healthcare provider has told you to leave it uncovered.\n <br/>\n\t\t\t• Talk to your healthcare provider if your skin does not improve after 3 to 5 days of treatment with mupirocin ointment.\n <br/>\n\t\t\t• If you are breastfeeding and use mupirocin ointment on your breast or nipple, wash the area well before breastfeeding your child.\n </td>\n</tr>\n<tr>\n<td><span class=\"Bold\">What are the possible side effects of mupirocin ointment? </span>\n<br/>\n\t\t\tMupirocin ointment may cause serious side effects, including:\n <br/>\n<span class=\"Bold\">• severe allergic reactions.</span> Stop using mupirocin ointment and call your healthcare provider or go to the nearest emergency room right away if you have any of the following signs or symptoms of a severe allergic reaction:\n <br/>\n\t\t\t• hives • trouble breathing or wheezing\n <br/>\n\t\t\t• swelling of your face, lips, mouth, or tongue • dizziness, fast heartbeat or pounding in your chest\n <br/>\n\t\t\t• a rash over your whole body\n <br/>\n<span class=\"Bold\">• eye irritation.</span> Do not get mupirocin ointment in your eyes. If mupirocin ointment gets in your eyes, rinse your eyes well with water.\n <br/>\n<span class=\"Bold\">• irritation in the area mupirocin ointment is used.</span> Stop using mupirocin ointment and call your healthcare provider if you develop an irritation, severe itching, or a rash while using mupirocin ointment.\n <br/>\n<span class=\"Bold\">• a type of diarrhea called clostridium difficile-associated diarrhea (CDAD).</span> CDAD may happen in people who use or have used medicine to treat bacterial infections. The severity of CDAD can range from mild diarrhea to severe diarrhea that may cause death (fatal colitis). Call your healthcare provider or go to the nearest emergency room right away if you have diarrhea while using or after you stop using mupirocin ointment.\n <br/>\n<span class=\"Bold\">• risk of absorption of polyethylene glycol through the skin. </span>Mupirocin ointment contains polyethylene glycol, which in large amounts can cause kidney damage. You should not apply mupirocin ointment to open skin wounds or damaged skin, especially if you have kidney problems.\n <br/>\n<span class=\"Bold\">• increased risk of infection at IV (intravenous) sites.</span> Mupirocin ointment should not be used on skin that is near an IV (intravenous) site.\n <br/>\n\t\t\tThe most common side effects of mupirocin ointment include:\n <br/>\n\t\t\t• burning\n <br/>\n\t\t\t• stinging or pain\n <br/>\n\t\t\t• itching\n <br/>\n\t\t\tThese are not all the possible side effects of mupirocin ointment. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.\n </td>\n</tr>\n<tr>\n<td><span class=\"Bold\">How should I store mupirocin ointment? </span>\n<br/>\n\t\t\tStore mupirocin ointment at room temperature between 68°F to 77°F (20°C to 25°C).\n <br/>\n<span class=\"Bold\">Keep mupirocin ointment and all medicines out of the reach of children.</span></td>\n</tr>\n<tr>\n<td><span class=\"Bold\">General information about the safe and effective use of mupirocin ointment </span>\n<br/>\n\t\t\tMedicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use mupirocin ointment for a condition for which it was not prescribed. Do not give mupirocin ointment to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about mupirocin ointment that is written for health professionals.\n </td>\n</tr>\n<tr class=\"Last\">\n<td><span class=\"Bold\">What are the ingredients in mupirocin ointment? </span>\n<br/>\n<span class=\"Bold\">Active Ingredient:</span> mupirocin\n <br/>\n<span class=\"Bold\">Inactive Ingredients:</span> polyethylene glycol 400 and polyethylene glycol 3350\n <br/>\n\t\t\tFor more information, call 1-833-537-4679\n </td>\n</tr>\n</tbody>\n</table></div>" }

This Patient Information has been approved by the U.S. Food and Drug Administration.

{ "type": "p", "children": [], "text": "This Patient Information has been approved by the U.S. Food and Drug Administration." }

Distributed by: Kesin Pharma Oldsmar, FL 34677 Revised : June 2025 V01

{ "type": "p", "children": [], "text": "Distributed by:\n \nKesin Pharma\n \nOldsmar, FL 34677\n \nRevised : June 2025\n \nV01\n " }

NDC 8133-032-50

{ "type": "p", "children": [], "text": "NDC 8133-032-50" }

Mupirocin Ointment, USP 2%

{ "type": "p", "children": [], "text": "\nMupirocin Ointment, USP 2%\n" }

Delivers 1 gram

{ "type": "p", "children": [], "text": "Delivers 1 gram" }

Rx Only

{ "type": "p", "children": [], "text": "\nRx Only\n" }

FOR INSTITUTIONAL USE ONLY

{ "type": "p", "children": [], "text": "\nFOR INSTITUTIONAL USE ONLY\n" }

NDC 8133-032-99

{ "type": "p", "children": [], "text": "NDC 8133-032-99" }

Mupirocin Ointment, USP 2%

{ "type": "p", "children": [], "text": "\nMupirocin Ointment, USP 2%\n" }

Delivers 1 gram

{ "type": "p", "children": [], "text": "Delivers 1 gram" }

Rx Only

{ "type": "p", "children": [], "text": "\nRx Only\n" }

FOR INSTITUTIONAL USE ONLY

{ "type": "p", "children": [], "text": "\nFOR INSTITUTIONAL USE ONLY\n" }