Label: UNDECYLENIC ACID- maximum strength antifungal liquid solution liquid

  • Category: HUMAN OTC DRUG LABEL

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 July 19, 2021

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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 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 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 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 conditions persists longer, consult a doctorthis product is not effective on the scalp or nails
  • Other information

    • store at room temperature 15°-30°C (59° - 86°F)
    • protect from freezing. If freezing occurs warm to room temperature
    • keep tightly closed when not in use
  • ​Inactive ingredient

    isopropyl palmitate

  • Questions?

    Call 1-866-910-6874

  • Principal Display Panel

    Front Panel

    Compare to active ingredient in Fungi-Nail ® anti-fungal solution *

    maximum strength

    antifungal

    nail liquid

    25% undecylenic acid

    eliminates fungus on fingers, toes and around nails

    topical solution with brush applicator

    NET 1 FL OZ (30mL)

    Side Panel

    Eliminates and helps stop the spread of fungal infections on cuticles, around nail edges, and under nail tips where reachable with applicator brush. Topical antifungal treatment will not penetrate hard nail surfaces.

    *This product is not manufactured or distributed by Kramer Laboratories, Inc., owner of the registered trademark Fungi-Nail®.

    antifungal nail liquid solution 1

    Antifungal nail liquid solution 2

  • INGREDIENTS AND APPEARANCE
    UNDECYLENIC ACID 
    maximum strength antifungal liquid solution liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11673-259
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    UNDECYLENIC ACID (UNII: K3D86KJ24N) (UNDECYLENIC ACID - UNII:K3D86KJ24N) UNDECYLENIC ACID25 mg  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11673-259-3030 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product06/01/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C06/01/2014
    Labeler - Target Corporation (006961700)