Label: UNDECYLENIC ACID liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 5, 2023

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  • ACTIVE INGREDIENT

    ​Undecylenic Acid 25%

  • PURPOSE

    Antifungal

  • USES:

    Cures most athlete’s foot (tinea pedis) and ringworm (tinea corporis).

    Relieves itching, scaling, cracking, burning, and redness.

  • WARNINGS

    For external use only.

    Do not use on children under 2 years of age unless directed by a doctor.

    Avoid contact with eyes. If contact occurs, rinse thoroughly with water

  • EXTREMELY FLAMMABLE:

    Keep away from fire or flame.

  • STOP USE AND ASK A DOCTOR IF

    Irritation occurs or if there is no improvement within 4 weeks.

  • KEEP OUT OF REACH OF CHILDREN

    If swallowed, get medical help or contact a Poison Control Center right away.

  • DIRECTIONS:

    Wash affected area and dry thoroughly. Apply a thin layer of the product over the affected area (around the nails and underneath nail tips) twice daily 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. If condition persists longer, consult a doctor. This product is not effective on the scalp or nails.

  • OTHER INFORMATION:

    Store at room temperature 15° - 30°C (59° - 86°F)

  • INACTIVE INGREDIENT

    Isopropyl Alcohol, Water (Aqua), Tocopheryl Acetate, DMDM Hydantoin, Melaleuca Alternifolia Leaf Oil.

  • PRONAIL FUNGUS KILLER

    FUNGUS KILLER

  • INGREDIENTS AND APPEARANCE
    UNDECYLENIC ACID 
    undecylenic acid liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49283-025
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    UNDECYLENIC ACID (UNII: K3D86KJ24N) (UNDECYLENIC ACID - UNII:K3D86KJ24N) UNDECYLENIC ACID25 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    WATER (UNII: 059QF0KO0R)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49283-025-0515 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product08/16/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00508/16/2018
    Labeler - Chemco Corporation (032495954)
    Registrant - Chemco Corporation (032495954)
    Establishment
    NameAddressID/FEIBusiness Operations
    Chemco Corporation032495954manufacture(49283-025)
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