Label: TRIPLE AF- miconazole nitrate paste
- NDC Code(s): 11086-040-01, 11086-040-02
- Packager: Summers Laboratories Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated October 9, 2023
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- WHEN USING
- STOP USE
- DO NOT USE
- KEEP OUT OF REACH OF CHILDREN
-
DOSAGE & ADMINISTRATION
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
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
TRIPLE AF
miconazole nitrate pasteProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11086-040 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 PETROLATUM (UNII: 4T6H12BN9U) ZINC OXIDE (UNII: SOI2LOH54Z) STARCH, CORN (UNII: O8232NY3SJ) LANOLIN (UNII: 7EV65EAW6H) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) YELLOW WAX (UNII: 2ZA36H0S2V) CHOLESTEROL (UNII: 97C5T2UQ7J) POLYSORBATE 80 (UNII: 6OZP39ZG8H) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11086-040-01 28.7 g in 1 TUBE; Type 0: Not a Combination Product 10/30/2013 2 NDC:11086-040-02 57 g in 1 TUBE; Type 0: Not a Combination Product 10/30/2013 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M005 10/30/2013 Labeler - Summers Laboratories Inc (002382612)