Label: MICONAZOLE NITRATE- anti-fungal powder miconazole nitrate talc free powder
- NDC Code(s): 36800-385-25
- Packager: Topco Associates LLC
- Category: HUMAN OTC DRUG LABEL
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Drug Label Information
Updated January 31, 2023
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- Official Label (Printer Friendly)
- 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 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, 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 ingredients
- Principal Display Panel
INGREDIENTS AND APPEARANCE
anti-fungal powder miconazole nitrate talc free powder
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:36800-385 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:36800-385-25 71 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 12/07/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333C 12/07/2017 Labeler - Topco Associates LLC (006935977)