Label: TRIPLE ANTIFUNGAL- miconazole nitrate ointment
- NDC Code(s): 16864-040-02
- Packager: Advantice Health, LLC
- 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.
Drug Label Information
Updated September 14, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Uses
- Warnings
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Directions
- Clean 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
- 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
- Questions?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 56.7 g Tube Carton
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INGREDIENTS AND APPEARANCE
TRIPLE ANTIFUNGAL
miconazole nitrate ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:16864-040 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 WHITE PETROLATUM (UNII: B6E5W8RQJ4) STARCH, CORN (UNII: O8232NY3SJ) LANOLIN (UNII: 7EV65EAW6H) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) YELLOW WAX (UNII: 2ZA36H0S2V) LEVOMENOL (UNII: 24WE03BX2T) CHOLESTEROL (UNII: 97C5T2UQ7J) WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) OAT (UNII: Z6J799EAJK) Product Characteristics Color WHITE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:16864-040-02 1 in 1 CARTON 09/01/2021 1 56.7 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 09/01/2021 Labeler - Advantice Health, LLC (192527062)