Label: PRIVATE LABEL ANTIFUNGAL BARRIER CREAM- 2% miconazole nitrate cream cream
- NDC Code(s): 60232-0009-2, 60232-0009-4, 60232-0009-5
- Packager: Swiss-American CDMO, LLC
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated November 7, 2023
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Warnings
For external use only. Not intended for ingestion. Do not use on children under 2 years of age unless directed by a doctor. Avoid contact with the eyes. For the treatment of athlete’s foot and ringworm: if irritation occurs or if there is no improvement within 4 weeks, discontinue use and consult a doctor. For the treatment of jock itch: if irritation occurs or there is no improvement within 2 weeks discontinue use and consult a doctor. Do not use for diaper rash. Keep out of the reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away
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Use and Directions
Proven clinically effective in the treatment of most athlete’s foot (tinea pedis), jock itch (tinea cruris) and ringworm (tinea sorporis). For the treatment of superficial skin infections caused by yeast (candida albicans). For effective relief of redness, irritation, scaling, itching, discomfort and burning.
Clean the affected area and dry thoroughly. Apply a thin layer of the product over affected area twice daily as directed by a doctor or health care professional. For athlete’s foot: pay special attention to spaces between the toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once daily. For athlete’s foot and ringworm, use daily for 4 weeks. For jock itch, use daily for 2 weeks. If condition persists longer, consult a doctor. This product is not effective on the scalp or nails.
- Keep out of reach of children
- DOSAGE & ADMINISTRATION
- Active Ingredient
- PURPOSE
- Inactive Ingredient
- Labeling
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INGREDIENTS AND APPEARANCE
PRIVATE LABEL ANTIFUNGAL BARRIER CREAM
2% miconazole nitrate cream creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:60232-0009 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE 20 g in 1000 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALLANTOIN (UNII: 344S277G0Z) EDETATE DISODIUM (UNII: 7FLD91C86K) SODIUM CHLORIDE (UNII: 451W47IQ8X) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PETROLATUM (UNII: 4T6H12BN9U) DIMETHICONE 1000 (UNII: MCU2324216) CETYL DIMETHICONE 25 (UNII: U4AS1BW4ZB) CETYL PEG/PPG-10/1 DIMETHICONE (HLB 1.5) (UNII: V2W71V8T0X) PROPYLPARABEN (UNII: Z8IX2SC1OH) HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY) YELLOW WAX (UNII: 2ZA36H0S2V) ZINC OXIDE (UNII: SOI2LOH54Z) ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M) CUCUMBER (UNII: YY7C30VXJT) Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:60232-0009-2 60 g in 1 TUBE; Type 0: Not a Combination Product 11/22/2010 2 NDC:60232-0009-4 120 g in 1 TUBE; Type 0: Not a Combination Product 11/22/2010 3 NDC:60232-0009-5 150 g in 1 TUBE; Type 0: Not a Combination Product 11/22/2010 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M017 11/22/2010 Labeler - Swiss-American CDMO, LLC (080170933) Registrant - Swiss-American CDMO, LLC (080170933) Establishment Name Address ID/FEI Business Operations Swiss-American CDMO, LLC 080170933 manufacture(60232-0009)