Label: MICONAZOLE NITRATE- antifungal miconazorb af powder talc free powder
- NDC Code(s): 55319-144-71
- Packager: Family Dollar Services 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.
Updated July 20, 2021
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- Active Ingredients
For external use only.
Stop use 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 the 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 & 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
- Pincipal Display Panel
INGREDIENTS AND APPEARANCE
antifungal miconazorb af powder talc free powder
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55319-144 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 TRICALCIUM PHOSPHATE (UNII: K4C08XP666) CHLOROXYLENOL (UNII: 0F32U78V2Q) IMIDUREA (UNII: M629807ATL) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) ZEA MAYS SUBSP. MAYS WHOLE (UNII: 1G5HNE09V8) ALLANTOIN (UNII: 344S277G0Z) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55319-144-71 71 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 10/01/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333C 10/01/2019 Labeler - Family Dollar Services Inc. (024472631)