Label: SELAN ANTIFUNGAL cream

  • NDC Code(s): 0159-2500-04
  • Packager: Trividia Manufacturing Solutions, Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 16, 2024

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  • Active Ingredients

    Miconazole nitrate 2%

  • Purpose

    Antifungal

  • Uses

     - Cures most jock itch (tinea cruris), ringworm (tinea corporis), athlete's foot (tinea pedis) and superficial yeast infections

     - Relieves itching, cracking, burning, redness, irritation and discomfort associated with these conditions

  • Warnings

    For external use only

  • DO NOT USE

    Do not use on children under 2 years old unless directed by a doctor

  • WHEN USING

    When using this product avoid contact with the eyes

  • STOP USE

    Stop use and ask a doctor if irritation occurs or if there is no improvement

  • KEEP OUT OF REACH OF CHILDREN

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

  • Directions

     - Clean affected area and dry thoroughly

     - Apply a thin layer over the affected area twice daily (morning and night) for 2 weeks (jock itch) or 4 weeks (athlete's foot & ringworm)

     - Supervise children in the use of this product

    For athlete's foot  *pay special attention to the space between the toes  *wear well fitting, ventilated shoes  *change shoes and socks at least once daily

    If condition persists longer, or if irritiation occurs, consult a doctor. This product is not effective on the scalp or nails.

  • Other information

    store at room temperature

  • Inactive ingredients:

    Dimethicone, emulsifying wax, fragrance, germaben II, lanolin, propylene glycol, water, zinc oxide

  • Image of 4oz tube

    Selan Antifungal 4oz label

  • INGREDIENTS AND APPEARANCE
    SELAN ANTIFUNGAL 
    selan antifungal cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0159-2500
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    LANOLIN (UNII: 7EV65EAW6H)  
    DIMETHICONE 1000 (UNII: MCU2324216)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    POLAWAX POLYSORBATE (UNII: Q504PL8E0V)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0159-2500-04117 g in 1 TUBE; Type 0: Not a Combination Product11/05/2003
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00511/05/2003
    Labeler - Trividia Manufacturing Solutions, Inc (018927392)
    Establishment
    NameAddressID/FEIBusiness Operations
    Trividia Manufacturing Solutions, Inc018927392manufacture(0159-2500) , label(0159-2500) , pack(0159-2500)
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