Label: SELAN ANTIFUNGAL cream

  • NDC Code(s): 0159-2500-04
  • Packager: Trividia Manufacturing Solutions, Inc
  • 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 February 16, 2022

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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 finalpart333C11/05/2003
    Labeler - Trividia Manufacturing Solutions, Inc (018927392)
    Establishment
    NameAddressID/FEIBusiness Operations
    Trividia Manufacturing Solutions, Inc018927392manufacture(0159-2500) , label(0159-2500) , pack(0159-2500)