NDC | 50066-277-03 |
Set ID | 828026cc-ea65-7b3d-e053-2a91aa0a7588 |
Category | HUMAN OTC DRUG LABEL |
Packager | Genomma Lab |
Generic Name | |
Product Class | Azole Antifungal |
Product Number | |
Application Number | PART333C |
- Active Ingredient
- Purpose
- Uses
- Warnings
- Keep Out of Reach of Children.
-
Directions
- Clean the affected area and dry thoroughly.
- Apply a thin layer of the product over the affected area twice daily (morning and night) or as directed by a doctor.
- Supervise children in the use of this product.
- Pay special attention to space between the toes; wear well-fitting, ventilated shoes and change socks at least once daily.
- Use daily for 4 weeks.
- If condition persists longer, consult a doctor.
- This product is not effective on scalp and nails.
- Inactive Ingredients
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
SILKA ANTIFUNGAL FOOT
miconazole nitrate powderProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50066-277 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 ALPHA CELLULOSE (UNII: I355QGZ19A) CHLOROXYLENOL (UNII: 0F32U78V2Q) IMIDUREA (UNII: M629807ATL) TALC (UNII: 7SEV7J4R1U) ALDIOXA (UNII: 8T66I31YNK) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50066-277-03 85 g in 1 BOTTLE; Type 0: Not a Combination Product 08/09/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333C 08/09/2018 Labeler - Genomma Lab (832323534) Registrant - Derma Care Research Labs (116817470) Establishment Name Address ID/FEI Business Operations Derma Care Research labs 116817470 manufacture(50066-277)