Label: ANTIFUNGAL CREAM- antifungal cream
- NDC Code(s): 68788-8645-2
- Packager: Preferred Pharmaceuticals Inc.
- This is a repackaged label.
- Source NDC Code(s): 68001-481
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated May 1, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active ingredient
- Purpose
-
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
-
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)
-
INGREDIENTS AND APPEARANCE
ANTIFUNGAL CREAM
antifungal creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68788-8645(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:68788-8645-2 1 in 1 CARTON 05/01/2024 1 28.4 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 05/01/2024 Labeler - Preferred Pharmaceuticals Inc. (791119022) Registrant - Preferred Pharmaceuticals Inc. (791119022) Establishment Name Address ID/FEI Business Operations Preferred Pharmaceuticals Inc. 791119022 RELABEL(68788-8645)
