Label: ANTI- FUNGAL MICONAZOLE NITRATE- miconazole nitrate powder
- NDC Code(s): 56104-253-01
- Packager: Premier Brands of America Inc.
- 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.
Drug Label Information
Updated January 25, 2023
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- Active ingredient
For external use only.
Stop and ask a doctor if
irritation occurs or there is no improvement within 4 weeks for athlete's foot and ringworm, or 2 weeks for jock itch.
- clean the affected area & 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, 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 conditions persist longer, consult a doctor
- this product is not effective on the scalp or nails
- Other information
- Inactive ingredient
- Principal Display Panel
INGREDIENTS AND APPEARANCE
ANTI- FUNGAL MICONAZOLE NITRATE
miconazole nitrate powder
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:56104-253 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE 1.42 g in 71 g Inactive Ingredients Ingredient Name Strength ALLANTOIN (UNII: 344S277G0Z) CHLOROXYLENOL (UNII: 0F32U78V2Q) IMIDUREA (UNII: M629807ATL) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) TRICALCIUM PHOSPHATE (UNII: K4C08XP666) ZEA MAYS SUBSP. MAYS WHOLE (UNII: 1G5HNE09V8) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:56104-253-01 71 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 01/05/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333C 04/11/2022 Labeler - Premier Brands of America Inc. (117557458)