Label: ANTIFUNGAL CREAM- antifungal cream
- NDC Code(s): 68001-481-45, 68001-481-47, 68001-481-48
- Packager: BluePoint Laboratories
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated November 17, 2023
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active ingredient
- Purpose
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Uses
- For the treatment of most athlete's foot (tinea pedis), jock itch (tinea cruris), Ringworm (tinea corporis).
- For the treatment of superficial skin infections caused by yeast (Candida Albicans)
- Relieves itching, scaling, burning, discomfort and chafing associated with jock itch or itching, burning feet.
- Warnings
- Do not use
- When using this product
- Stop use and ask a doctor if
- Keep out of reach of children
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Directions
- Clean the affected area and dry thoroughly.
- Apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctor.
- Supervise children in the use of this product.
- 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 scalp or nails.
- Other information
- Inactive ingredients
- Questions?
- 2% Miconazole Nitrate Cream, USP Carton 1oz (28.4g)
- 2% Miconazole Nitrate Cream, USP Tube 1oz (28.4g)
- 2% Miconazole Nitrate Cream, USP Carton 0.5oz (14.2g)
- 2% Miconazole Nitrate Cream, USP Tube 0.5oz (14.2g)
- 2% Miconazole Nitrate Cream, USP Carton 1.5oz (42.5g)
- 2% Miconazole Nitrate Cream, USP Tube 1.5oz (42.5g)
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INGREDIENTS AND APPEARANCE
ANTIFUNGAL CREAM
antifungal creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68001-481 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE 2 g in 100 g Inactive Ingredients Ingredient Name Strength EDETATE DISODIUM (UNII: 7FLD91C86K) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) LIGHT MINERAL OIL (UNII: N6K5787QVP) CHLOROCRESOL (UNII: 36W53O7109) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) WHITE PETROLATUM (UNII: B6E5W8RQJ4) SODIUM PHOSPHATE DIBASIC DIHYDRATE (UNII: 94255I6E2T) SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE (UNII: 5QWK665956) POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68001-481-45 1 in 1 CARTON 12/01/2020 1 28.4 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:68001-481-47 1 in 1 CARTON 12/01/2020 2 42.5 g in 1 TUBE; Type 0: Not a Combination Product 3 NDC:68001-481-48 1 in 1 CARTON 12/01/2020 3 14.2 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M005 12/01/2020 Labeler - BluePoint Laboratories (985523874) Establishment Name Address ID/FEI Business Operations Gopaldas Visram & Co., Ltd 858030888 manufacture(68001-481)