Label: ANTI-FUNGAL POWDER MICONAZOLE NITRATE- miconazole nitrate powder
- NDC Code(s): 56104-500-00
- Packager: Premier Brands of America Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated October 14, 2024
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- Active ingredient
- Purpose
- Uses
- Warnings
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Directions
- clean the affected area and dry thoroughly
- apply a thin layer of 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, & change shoes & 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 conditions persist longer, consult a doctor
- this product is not effective on the scalp or nails
- Other information
- Inactive ingredients
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INGREDIENTS AND APPEARANCE
ANTI-FUNGAL POWDER MICONAZOLE NITRATE
miconazole nitrate powderProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:56104-500 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE 20 mg in 1 g Inactive Ingredients Ingredient Name Strength ALDIOXA (UNII: 8T66I31YNK) CHLOROXYLENOL (UNII: 0F32U78V2Q) IMIDUREA (UNII: M629807ATL) POWDERED CELLULOSE (UNII: SMD1X3XO9M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:56104-500-00 71 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 09/12/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M005 09/12/2023 Labeler - Premier Brands of America Inc. (063849780)