Drug Catalog - Product Detail
Mupirocin Cream 2% 30GM
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 69150-0225-03 | BIOMES PHARMACEUTICALS | 30 | 2% | NA |
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Description
11 DESCRIPTION Mupirocin cream USP, 2% contains the dihydrate crystalline calcium hemi-salt of the RNA synthetase inhibitor antibacterial, mupirocin. Chemically, it is (α 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-3,4-dihydroxy-β-methyl-2 H -pyran-2-crotonic acid, ester with 9-hydroxynonanoic acid, calcium salt (2:1), dihydrate. The molecular formula of mupirocin calcium USP is (C 26 H 43 O 9 ) 2 Ca•2H2O, and the molecular weight is 1075.3. The molecular weight of mupirocin free acid is 500.6. The structural formula of mupirocin calcium USP is: Mupirocin cream USP is a white cream that contains 2.15% w/w mupirocin calcium USP (equivalent to 2% mupirocin free acid) in an oil- and water-based emulsion. The inactive ingredients are benzyl alcohol, glycerol monostearate, mineral oil, phenoxyethanol, polyoxyl 20 cetostearyl ether, purified water and xanthan gum. structure
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING Mupirocin cream USP, 2% is supplied in 15-gram and 30-gram tubes. Mupirocin cream USP is a white cream that contains 2.15% w/w mupirocin calcium USP (equivalent to 2% mupirocin free acid) in an oil- and water-based emulsion. NDC 69150-225-01 15-gram tube (1 tube per carton) NDC 69150-225-03 30-gram tube (1 tube per carton) Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Do not freeze.
Indications & Usage
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 cm 2 in area) due to susceptible isolates of Staphylococcus aureus (S. aureus) and Streptococcus pyogenes (S. pyogenes) . Mupirocin cream is an RNA synthetase inhibitor antibacterial indicated for the treatment of secondarily infected traumatic skin lesions (up to 10 cm in length or 100 cm2 in area) due to susceptible isolates of Staphylococcus aureus and Streptococcus pyogenes . ( 1 )
Dosage and Administration
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 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 )]. • Do not apply mupirocin cream concurrently with any other lotions, creams or ointments [see Clinical Pharmacology ( 12.3 )]. • For Topical Use Only. ( 2 ) • Apply a small amount of mupirocin cream, with a cotton swab or gauze pad, to the affected area 3 times daily for 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 )