DERMAFUNGAL (ANTIMICROBIAL DRUG PRODUCTS) CREAM [DERMARITE INDUSTRIES, LLC]

DERMAFUNGAL (ANTIMICROBIAL DRUG PRODUCTS) CREAM [DERMARITE INDUSTRIES, LLC]
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NDC 61924-234-04, 61924-234-05
Set ID 4e7739a1-cff0-4b76-94f0-d9f9af158df5
Category HUMAN OTC DRUG LABEL
Packager DermaRite industries, LLC
Generic Name
Product Class Azole Antifungal
Product Number
Application Number PART333C
  • Active Ingredient:

    Miconazole Nitrate 2%

  • Purpose:

    Antifungal

  • Uses:

    • For the treatment and prevention of most: athlete's foot, jock itch, ringworm
    • relieves itching, scaling,cracking, and discomfort associated with these conditions.
  • Warnings:

    • For external use only.
    • Avoid contact with eyes. In case of contact, flush thoroughly with water.
    • Stop use and ask doctor if irritation occurs , condition worsens or does not improve in 2 weeks for jock itch, or within 4 weeks for athlete's foot and ringworm.
  • Warnings

    • Keep out of reach of children. In case of accidental ingestion contact physician or Poison Control Center right away.
  • Directions

    Cleanse affected area and dry thoroughly. Apply a thin layer to affected area twice daily or as directed by physician.

    • For jockitch use daily for two weeks.
    • For athelete's foot use daily for four weeks.
  • Other Information:

    • This product is not effective on the scalp and nails.
    • Store at room temperature (59°-86°F)
  • Inactive Ingredients:

    Caprylic/Capric Triglyceride, Ceteareth-20, Disodium EDTA, Glyceryl Stearate, Methylparaben, PEG-40 Castor Oil, PEG-100 Stearate, Petrolatum, Propylene Glycol, Propylparaben, Stearic Acid, Water, Xantham Gum

  • Durmafungal Principal Display Panel and Drug Facts

    DermaFungal

  • INGREDIENTS AND APPEARANCE
    DERMAFUNGAL 
    antimicrobial drug products cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61924-234
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE0.02 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    IMIDUREA (UNII: M629807ATL)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PEG-40 CASTOR OIL (UNII: 4ERD2076EF)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    WATER (UNII: 059QF0KO0R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61924-234-055 g in 1 PACKET; Type 0: Not a Combination Product12/12/2005
    2NDC:61924-234-04106 g in 1 TUBE; Type 0: Not a Combination Product12/12/2005
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C12/12/2005
    Labeler - DermaRite industries, LLC (883925562)
    Registrant - Mark Friedman (883925562)
    Establishment
    NameAddressID/FEIBusiness Operations
    DermaRite industries, LLC883925562manufacture(61924-234)