Label: UNDECYLENIC ACID- anti-fungal liquid liquid

  • 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 September 16, 2020

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  • ​Active ingredient

    Undecylenic acid 25%w/w

  • ​Purpose

    Antifungal

  • Uses

    For cure of most tinea pedis (athlete's foot) and tinea corporis (ringworm).

    For relief of :

    • itching
    • burning
    • redness
    • irritation
    • scaling
    • soreness
    • discomfort which may accompany these conditions
  • Warnings

    For external use only

    ​If pregnant or breastfeeding

    consult a healthcare professional before use.

    ​Do not use

    on children under 2 years of age unless directed by a doctor

    ​When using this product

    avoid contact with eyes.

    ​Use only as directed

    by a doctor on persons with highly sensitive skin.

    ​Stop use and consult a doctor if

    • there is no improvement within 4 weeks
    • irritation occurs

    ​Keep out of reach of children.

    If accidental ingestion occurs, get medical help or contact a Poison Control Center right away.

  • ​Directions

    Read all warnings and directions. Use only as directed.

    • clean the affected area and dry thoroughly
    • apply a thin layer of the product over the affecter area twice daily (morning and night) or as directed by a doctor
    • supervise children in the use of this product
    • for athlete's foot: pay special attention to spaces between toeswear 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 conditions 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 palmitate

  • Questions?

    Call 1-866-964-0939

  • ​Principal Display Panel

    Walgreens

    Antifungal Liquid

    UNDECYLENIC ACID 25%

    MAXIMUM STRENGTH

    MEDICATED

    ANTIFUNGAL

    • Eliminates fungus on fingers, toes & around nails
    • Non-oily, clear liquid
    • Dries quickly

    NET WT 1 FL OZ (30mL)

    Liquid Solution

  • INGREDIENTS AND APPEARANCE
    UNDECYLENIC ACID 
    anti-fungal liquid liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-7731
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    UNDECYLENIC ACID (UNII: K3D86KJ24N) (UNDECYLENIC ACID - UNII:K3D86KJ24N) UNDECYLENIC ACID0.25 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-7731-3030 g in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product08/16/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C08/16/2012
    Labeler - Walgreen Company (008965063)