Label: MUPIROCIN cream

  • NDC Code(s): 46708-624-15, 46708-624-30
  • Packager: Alembic Pharmaceuticals Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated March 18, 2025

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  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use MUPIROCIN CREAM safely and effectively. See full prescribing information for MUPIROCIN CREAM. MUPIROCIN cream, for topical ...
  • Table of Contents
    Table of Contents
  • 1 INDICATIONS AND USAGE
    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 ...
  • 2 DOSAGE AND ADMINISTRATION
    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 ...
  • 3 DOSAGE FORMS AND STRENGTHS
    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.
  • 4 CONTRAINDICATIONS
    Mupirocin cream is contraindicated in patients with known hypersensitivity to mupirocin or any of the excipients of mupirocin cream.
  • 5 WARNINGS AND PRECAUTIONS
    5.1 Severe Allergic Reactions - Systemic allergic reactions, including anaphylaxis, urticaria, angioedema, and generalized rash, have been reported in patients treated with formulations of ...
  • 6 ADVERSE REACTIONS
    The following adverse reactions are discussed in more detail in other sections of the labeling: Severe Allergic Reactions [see Warnings and Precautions (5.1)] Eye Irritation [see ...
  • 8 USE IN SPECIFIC POPULATIONS
    8.1 Pregnancy - 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 ...
  • 11 DESCRIPTION
    Mupirocin cream USP, 2% contains the dihydrate crystalline calcium hemi-salt of the RNA synthetase inhibitor antibacterial, mupirocin. Chemically, it is ...
  • 12 CLINICAL PHARMACOLOGY
    12.1 Mechanism of Action - Mupirocin is an RNA synthetase inhibitor antibacterial [see Microbiology (12.4)]. 12.3 Pharmacokinetics - Absorption - Systemic absorption of mupirocin through ...
  • 13 NONCLINICAL TOXICOLOGY
    13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility - Long‑term studies in animals to evaluate carcinogenic potential of mupirocin calcium have not been conducted. Results of the following ...
  • 14 CLINICAL STUDIES
    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 ...
  • 15 REFERENCES
    Clinical and Laboratory Standards Institute (CLSI). Performance Standards for Antimicrobial Susceptibility Testing; Twenty-sixth Informational Supplement. CLSI document M100-S26. Clinical and ...
  • 16 HOW SUPPLIED/STORAGE AND HANDLING
    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. Mupirocin cream USP, 2% is supplied in 15-gram and ...
  • 17 PATIENT COUNSELING INFORMATION
    Advise the patient to read the FDA-approved patient labeling (Patient Information). Advise the patient to administer mupirocin cream as follows: Use mupirocin cream only as directed by the ...
  • PATIENT PACKAGE INSERT
  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
    15 gram Tube label - NDC 46708-624-15 - 15 grams - Mupirocin Cream USP, 2% 15 gram Carton label - NDC 46708-624-15 - 15 grams - Mupirocin Cream USP, 2%
  • INGREDIENTS AND APPEARANCE
    Product Information