Label: ANTIFUNGAL- miconazole nitrate powder
- NDC Code(s): 80513-771-03
- Packager: Advanced Rx LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated July 28, 2025
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- Active Ingredient
- Purpose
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Uses
- for the treatment of most athlete’s foot (tinea pedis), jock itch (tinea cruris), and 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
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Warnings
For external use only.
Do not use on children under 2 years of age unless directed by a doctor.
When using this product avoid contact with the eyes.
Stop and ask a doctor if
- for athlete’s foot and ringworm - if irritation occurs, or if there is no improvement within 4 weeks
- for jock itch - if irritation occurs, or if there is no improvement within 2 weeks
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Directions
- clean the affected area and dry thoroughly
- apply a thin layer of powder 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
- Questions?
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INGREDIENTS AND APPEARANCE
ANTIFUNGAL
miconazole nitrate powderProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:80513-771 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 ALLANTOIN (UNII: 344S277G0Z) CHLOROXYLENOL (UNII: 0F32U78V2Q) STARCH, CORN (UNII: O8232NY3SJ) IMIDUREA (UNII: M629807ATL) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) TRICALCIUM PHOSPHATE (UNII: K4C08XP666) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:80513-771-03 85 g in 1 BOTTLE; Type 0: Not a Combination Product 01/01/2025 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M005 01/01/2025 Labeler - Advanced Rx LLC (042795108) Registrant - Advanced Rx LLC (042795108) Establishment Name Address ID/FEI Business Operations Davion, Inc 079536689 manufacture(80513-771)
