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
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Updated November 3, 2021
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- Drug Facts
- Active ingredient
- 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.
- Do not use
- When using this product
- Stop use and ask a doctor if
- Keep out of reach of children
- 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
- 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)
INGREDIENTS AND APPEARANCE
Product 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) POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY) SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE (UNII: 5QWK665956) 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 final part333C 12/01/2020 Labeler - BluePoint Laboratories (985523874) Establishment Name Address ID/FEI Business Operations Gopaldas Visram & Co., Ltd 858030888 manufacture(68001-481)