Label: UNDECYLENIC ACID- antifungal solution 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 July 19, 2021

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

  • Active ingredient

    Undecylenic acid 25%w/w

  • Purpose

    Antifungal

  • Uses

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

    For relief of:

    • discomforts which may accompany these conditons
    • itching
    • burning
    • redness
    • irritation
    • scaling
    • soreness
  • 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 the doctor.

    When using this product

    avoid contact with eyes.

    use only as directed

    by the 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 affected area twice daily (morning and evening) 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 changes shoes and socks atleast 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 0 - 30 0C (59 0 - 86 0F)
    • protect from freezing. If freezing occurs warm to room temperature
    • keep tightly closed when not in use
  • Inactive ingredient

    isopropyl palmitate

  • Questions?

    Call 1-866-964-0939

  • Principal Display Panel

    Harmon FaceValues

    MAXIMUM STRENGTH

    Anti-Fungal SOLUTION

    Undecylenic Acid

    Eliminates fungus on fingers, toes, and around nails

    • Easy to apply
    • Dries quickly
    • Non-oily, clear formula
    • Lightly scented

    1 FL OZ (30mL)

    Harmon Anti-Fungal nail Solution.jpg

  • INGREDIENTS AND APPEARANCE
    UNDECYLENIC ACID 
    antifungal solution liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63940-027
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    UNDECYLENIC ACID (UNII: K3D86KJ24N) (UNDECYLENIC ACID - UNII:K3D86KJ24N) UNDECYLENIC ACID7.5 g  in 30 g
    Inactive Ingredients
    Ingredient NameStrength
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63940-027-1030 g in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product11/20/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C11/20/2013
    Labeler - Harmon Store Inc. (804085293)