Label: AZOLEN- miconazole nitrate tincture
- NDC Code(s): 58980-818-10
- Packager: Stratus Pharmaceuticals, 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 October 19, 2017
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredient
- Purpose
- Uses
- WARNINGS
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Directions
- Clean and dry the affected area.
- Cover the affected area with a thin layer twice a day (a.m. and p.m.) on skin, under nails and surrounding cuticle areas.
- Supervise children in the use of this product.
- For athlete's foot and ringworm use daily for four (4) weeks.
- This product is not effective on scalp or nails.
- Other Information
- Inactive Ingredients
- SPL UNCLASSIFIED SECTION
- Questions?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 29.57 mL Bottle Carton
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INGREDIENTS AND APPEARANCE
AZOLEN
miconazole nitrate tinctureProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58980-818 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 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Benzyl Alcohol (UNII: LKG8494WBH) Acetic Acid (UNII: Q40Q9N063P) Isopropyl Alcohol (UNII: ND2M416302) Laureth-4 (UNII: 6HQ855798J) Sodium Hydroxide (UNII: 55X04QC32I) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58980-818-10 1 in 1 BOX 09/15/2017 1 29.57 mL in 1 BOTTLE, WITH APPLICATOR; 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 09/15/2017 Labeler - Stratus Pharmaceuticals, Inc. (789001641) Establishment Name Address ID/FEI Business Operations TARMAC PRODUCTS INC 059890491 MANUFACTURE(58980-818) , LABEL(58980-818) , PACK(58980-818)