NDC | 76077-400-04, 76077-400-07 |
Set ID | 164afeb1-d8b1-4b2c-8e07-c1a27550c5ad |
Category | HUMAN OTC DRUG LABEL |
Packager | Novana Medical, LLC |
Generic Name | |
Product Class | Azole Antifungal |
Product Number | |
Application Number | PART333C |
- ACTIVE INGREDIENT
- PURPOSE
- WARNINGS
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INDICATIONS & USAGE
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.
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
NOVANA ANTIFUNGAL BARRIER WITH MICONAZOLE
miconazole nitrate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76077-400 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Miconazole Nitrate (UNII: VW4H1CYW1K) (Miconazole - UNII:7NNO0D7S5M) Miconazole Nitrate .02 mL in 1 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Cetyl Alcohol (UNII: 936JST6JCN) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) Petrolatum (UNII: 4T6H12BN9U) Lanolin (UNII: 7EV65EAW6H) Cod Liver Oil (UNII: BBL281NWFG) Propanediol (UNII: 5965N8W85T) Sodium Laureth Sulfate (UNII: BPV390UAP0) Propylene Glycol (UNII: 6DC9Q167V3) Diazolidinyl Urea (UNII: H5RIZ3MPW4) Methylparaben (UNII: A2I8C7HI9T) Propylparaben (UNII: Z8IX2SC1OH) Zinc Oxide (UNII: SOI2LOH54Z) Dimethicone (UNII: 92RU3N3Y1O) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76077-400-04 120 mL in 1 TUBE 2 NDC:76077-400-07 210 mL in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333C 04/04/2012 Labeler - Novana Medical, LLC (964916600) Registrant - O.L. PRODUCTS, INC. (961405883) Establishment Name Address ID/FEI Business Operations Novana Medical, LLC 964916600 label, manufacture