mupirocin

Product Type: HUMAN PRESCRIPTION DRUG

Route: TOPICAL

Dosage Form:

NDC: 45802-112

Application: ANDA065123

Effective: 20231231

1 INDICATIONS AND USAGE Mupirocin Ointment USP, 2% is indicated for the topical treatment of impetigo due to susceptible isolates of Staphylococcus aureus (S. aureus) and Streptococcus pyogenes (S. pyogenes) . Mupirocin Ointment USP, 2% is an RNA synthetase inhibitor antibacterial indicated for the topical treatment of impetigo due to susceptible isolates of Staphylococcus aureus and Streptococcus pyogenes. ( 1 )

2 DOSAGE AND ADMINISTRATION • For Topical Use Only. • Apply a small amount of Mupirocin Ointment USP, 2%, 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 USP, 2% is not for intranasal, ophthalmic, or other mucosal use [ see Warnings and Precautions (5.2, 5.6) ]. • Do not apply Mupirocin Ointment USP, 2% concurrently with any other lotions, creams, or ointments [ see Clinical Pharmacology (12.3) ]. • For Topical Use Only. ( 2 ) • Apply a small amount of Mupirocin Ointment USP, 2%, with a cotton swab or gauze pad, to the affected area 3 times daily for up to 10 days. ( 2 ) • Re-evaluate patients not showing a clinical response within 3 to 5 days. ( 2 ) • Not for intranasal, ophthalmic, or other mucosal use. ( 2 )

4 CONTRAINDICATIONS Mupirocin Ointment USP, 2% is contraindicated in patients with known hypersensitivity to mupirocin or any of the excipients of Mupirocin Ointment USP, 2%. • Known hypersensitivity to mupirocin or any of the excipients of Mupirocin Ointment USP, 2%. ( 4 )

Not available.

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 Warnings and Precautions (5.2) ] • Local Irritation [ see Warnings and Precautions (5.3) ] • Clostridium difficile -Associated Diarrhea [ see Warnings and Precautions (5.4) ] • The most frequent adverse reactions (at least 1%) were burning, stinging or pain, and itching. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Padagis at 1-866-634-9120 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience 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. 6.2 Postmarketing Experience 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) ].