Label: UNDECYLENIC ACID liquid

  • NDC Code(s): 70947-025-15
  • Packager: Worldwide Cosmetics, 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 June 28, 2022

If you are a consumer or patient please visit this version.

  • DOSAGE & ADMINISTRATION

    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.

  • INACTIVE INGREDIENT

    Isopropyl Alcohol, Aqua, Tocopheryl Acetate, Melaleuca Alternifolia Leaf Oil.

  • INDICATIONS & USAGE

    Shake well before using. 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.

    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.

  • KEEP OUT OF REACH OF CHILDREN

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

  • PURPOSE

    Antifungal

  • ACTIVE INGREDIENT

    Undecylenic Acid 25%

  • WARNINGS

    Use only as directed.

    For external use only.

  • PRINCIPAL DISPLAY PANEL

    Main Label

  • INGREDIENTS AND APPEARANCE
    UNDECYLENIC ACID 
    undecylenic acid liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70947-025
    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
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70947-025-1515 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product10/01/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM00510/01/2016
    Labeler - Worldwide Cosmetics, Inc (013176366)
    Establishment
    NameAddressID/FEIBusiness Operations
    Chemco Corporation032495954manufacture(70947-025)