NDC | 68599-0207-3 |
Set ID | 31096041-28c9-4b16-bbd1-dbadefd37505 |
Category | HUMAN OTC DRUG LABEL |
Packager | McKesson Medical-Surgical Inc. |
Generic Name | |
Product Class | Azole Antifungal |
Product Number | |
Application Number | PART333C |
- Active ingredient
- Purpose
- Keep out of reach of children.
- 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
- If condition persists longer, consult a doctor. This product is not effective on the scalp or nails
- Other information
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Inactive ingredients
Aleurites Moluccana Seed Oil, Aloe Barbadensis Juice, Bisabolol, Calcium Pantothenate (Vitamin B5), Carthamus Tinctorius (Safflower) Oleosomes, Cellulose, Fragrance, Glycerin, Hydrated Silica, Maltodextrin, Niacinamide (Vitamin B3), Pyridoxine HCL (Vitamin B6), Sodium Ascorbyl Phosphate (Vitamin C), Sodium Bicarbonate, Sodium Hyaluronate, Sodium Starch Octenylsuccinate, Tocopheryl Acetate (Vitamin E), Zea Mays (Corn) Starch, Zingiber Officinale (Ginger) Root Extract
- Principal Display Panel
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INGREDIENTS AND APPEARANCE
THERA ANTIFUNGAL BODY
miconazole nitrate powderProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68599-0207 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 CARTHAMUS TINCTORIUS SEED OLEOSOMES (UNII: 9S60Q72309) CELLULOSE ACETATE (UNII: 3J2P07GVB6) GLYCERIN (UNII: PDC6A3C0OX) HYDRATED SILICA (UNII: Y6O7T4G8P9) SODIUM BICARBONATE (UNII: 8MDF5V39QO) KUKUI NUT OIL (UNII: TP11QR7B8R) ALOE VERA LEAF (UNII: ZY81Z83H0X) MALTODEXTRIN (UNII: 7CVR7L4A2D) NIACINAMIDE (UNII: 25X51I8RD4) PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR) .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) LEVOMENOL (UNII: 24WE03BX2T) HYALURONATE SODIUM (UNII: YSE9PPT4TH) STARCH, CORN (UNII: O8232NY3SJ) GINGER OIL (UNII: SAS9Z1SVUK) CALCIUM PANTOTHENATE (UNII: 568ET80C3D) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68599-0207-3 85 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 08/20/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333C 09/01/2011 Labeler - McKesson Medical-Surgical Inc. (023904428) Establishment Name Address ID/FEI Business Operations Central Solutions 007118524 manufacture(68599-0207)