Label: MICONAZOLE NITRATE powder
- NDC Code(s): 69367-399-85
- Packager: Westminster Pharmaceuticals, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated May 21, 2024
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
- for the treatment of most athlete's foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis)
- for the treatment of most superficial skin infections caused by yeast (candida albicans)
- relieves most itching, scaling, cracking, burning, redness, soreness, irritation, discomfort and chafing associated with jock itch
-
Warnings
- for external use only
Do not use
- on children under 2 years of age unless by a doctor
- avoid contact with the eyes
- for athlete's foot and ringworm - if irritation occurs, or if there is no improvement within 4 weeks, discontinue use and consult a doctor
- for jock itch - if irritation occurs, or if there is no improvement within 2 weeks, dicontinue use and consult a doctor
-
Directions
- clean the affected area and dry thoroughly
- apply a thin layer of powder 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 toes; wear well - fitting, ventilated shoes, and change shoes and socks at least once daily
- for athletes foot and 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
- PRINCIPAL DISPLAY PANEL - 85 g Bottle Label
-
INGREDIENTS AND APPEARANCE
MICONAZOLE NITRATE
miconazole nitrate powderProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69367-399 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 ALLANTOIN (UNII: 344S277G0Z) CHLOROXYLENOL (UNII: 0F32U78V2Q) IMIDUREA (UNII: M629807ATL) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) TRICALCIUM PHOSPHATE (UNII: K4C08XP666) STARCH, CORN (UNII: O8232NY3SJ) Product Characteristics Color WHITE (White to off-white) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69367-399-85 85 g in 1 BOTTLE; Type 0: Not a Combination Product 05/16/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH DRUG M005 05/16/2024 Labeler - Westminster Pharmaceuticals, LLC (079516651) Establishment Name Address ID/FEI Business Operations Davion, Inc 079536689 ANALYSIS(69367-399) , MANUFACTURE(69367-399) , PACK(69367-399) , LABEL(69367-399)
