Label: NOVANA ANTIFUNGAL BARRIER WITH MICONAZOLE- miconazole nitrate cream

  • Category: HUMAN OTC DRUG LABEL

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

    Active ingredient                       Purpose
    Miconazole Nitrate 2%..............Antifungal

  • PURPOSE

    Indications For effective treatment of athlete's foot (dermatophytosis), jock itch (tinea cruris), and ringworm (tinea corporis). • For the relief of burning, redness, irritation, discomfort, itching, scaling, and cracking.

  • WARNINGS

    Warnings 

    For external use only. 

    Do not use on children under 2 years of age unless directed by a doctor. Avoid contact with the eyes • If irritation occurs or if there is no improvement within 4 weeks, discontinue use and consult a doctor.

    Keep this and all drugs out of the reach of children.  If swallowed, get medical help or contact a Poison Control Center right away.

  • 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.

    Use Daily for 2 weeks.
    If condition persists, consult a doctor. This product is not effective on scalp or nails.

  • INACTIVE INGREDIENT

    Inactive ingredients
    Cetyl Alcohol,Cod Liver Oil, Diazolidinyl Urea, Dimethicone, Glyceryl Stearate, Lanolin Oil, Methylparaben, Petrolatum, Propanediol, Propylene Glycol, Propylparaben, Sodium Laureth Sulfate, Water, Zinc Oxide

  • PRINCIPAL DISPLAY PANEL


    Label of Product

  • INGREDIENTS AND APPEARANCE
    NOVANA ANTIFUNGAL BARRIER WITH MICONAZOLE 
    miconazole nitrate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76077-400
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Miconazole Nitrate (UNII: VW4H1CYW1K) (Miconazole - UNII:7NNO0D7S5M) Miconazole Nitrate.02 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76077-400-04120 mL in 1 TUBE
    2NDC:76077-400-07210 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C04/04/2012
    Labeler - Novana Medical, LLC (964916600)
    Registrant - O.L. PRODUCTS, INC. (961405883)
    Establishment
    NameAddressID/FEIBusiness Operations
    Novana Medical, LLC964916600label, manufacture