Label: NOVANA ANTIFUNGAL BARRIER WITH MICONAZOLE- miconazole nitrate cream
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Contains inactivated NDC Code(s)
NDC Code(s): 76077-400-04, 76077-400-07 - Packager: Novana Medical, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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 April 4, 2012
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- 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