Label: MICONAZOLE NITRATE cream
- NDC Code(s): 51672-2001-1, 51672-2001-2
- Packager: Taro Pharmaceuticals U.S.A., Inc.
- Category: HUMAN OTC DRUG LABEL
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 30, 2020
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Uses
- Warnings
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Directions
- clean the affected area and 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, 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
- not effective on the scalp or nails
- Other information
- Inactive ingredients
- Questions?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 15 g Tube Carton
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INGREDIENTS AND APPEARANCE
MICONAZOLE NITRATE
miconazole nitrate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51672-2001 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 apricot kernel oil (UNII: 54JB35T06A) benzoic acid (UNII: 8SKN0B0MIM) butylated hydroxytoluene (UNII: 1P9D0Z171K) glycol stearate (UNII: 0324G66D0E) mineral oil (UNII: T5L8T28FGP) polyethylene glycol 300 (UNII: 5655G9Y8AQ) water (UNII: 059QF0KO0R) PEG-6 stearate (UNII: 8LQC57C6B0) PEG-32 stearate (UNII: 33GX5WQC0M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51672-2001-1 1 in 1 CARTON 10/01/1991 1 15 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:51672-2001-2 1 in 1 CARTON 10/01/1991 2 30 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part333C 10/01/1991 Labeler - Taro Pharmaceuticals U.S.A., Inc. (145186370) Establishment Name Address ID/FEI Business Operations Taro Pharmaceuticals Inc. 206263295 MANUFACTURE(51672-2001)