Label: MICONAZOLE NITRATE ANTIFUNGAL POWDER powder
- NDC Code(s): 10135-720-85
- Packager: Marlex Pharmaceuticals, Inc.
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated November 9, 2023
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- Official Label (Printer Friendly)
- Active ingredient
- Purpose
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Uses
- For the treatment of most athlete's foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis)
- For the treatment of most superficial skin infections caused by yeast (candida albicans)
- Relieves most itching, scaling, cracking, burning, redness, soreness, irritation, discomfort and chafing associated with jock itch
- Warnings
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Do not use
- on children under 2 years of age unless directed by a doctor
- avoid contact with the eyes
- for athlete's foot and ringworm- if irritation occurs, or if there is no improvement within 4 weeks, discontinue use and consult a doctor
- for jock itch - if irritation occurs or if there is no improvement within 2 weeks, discontinue use and consult a doctor
- Keep out of reach of children
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Directions
- Clean the affected area and dry thoroughly
- Apply a layer of power over affected area twice a day (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 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 the scalp or nails.
- Other Information
- Inactive ingredients
- Principal Display Panel
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INGREDIENTS AND APPEARANCE
MICONAZOLE NITRATE ANTIFUNGAL POWDER
miconazole nitrate antifungal powder powderProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10135-720 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 CHLOROXYLENOL (UNII: 0F32U78V2Q) IMIDUREA (UNII: M629807ATL) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) TRICALCIUM PHOSPHATE (UNII: K4C08XP666) ALLANTOIN (UNII: 344S277G0Z) STARCH, CORN (UNII: O8232NY3SJ) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10135-720-85 85 g in 1 BOTTLE; Type 0: Not a Combination Product 05/01/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M005 05/01/2022 Labeler - Marlex Pharmaceuticals, Inc. (782540215)
