NOVANA ANTIFUNGAL BARRIER WITH MICONAZOLE (MICONAZOLE NITRATE) CREAM [NOVANA MEDICAL, LLC]

NOVANA ANTIFUNGAL BARRIER WITH MICONAZOLE (MICONAZOLE NITRATE) CREAM [NOVANA MEDICAL, LLC]
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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

    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