Label: UNDECYLENIC ACID- antifungal pen 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 12, 2021

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

  • Active ingredient

    Undecylenic acid 25%w/w

  • Purpose

    Antifungal

  • Uses

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

    For relief of:

    • itching
    • burning
    • redness
    • irritation
    • scaling
    • discomforts which may accompany these conditions
    • 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 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 warning and directions. Use only as directed.

    • clean the affected area and dry thoroughly
    • twist pen base with 3 clicks to saturate brush
    • apply a thin layer of the product over the affected area twice daily (morning and night) or as directed by the doctor
    • the brush applicator allows for easy application under nails and surrounding cuticle area
    • 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)
    • protect from freezing. if freezing occurs, warm to room temperature.
    • keep tightly closed when not in use
  • Inactive ingredient

    isopropyl palmitate

  • Questions?

    Call 1-888-287-1915

  • Principal Display Panel

    Equate

    Anti-Fungal Pen

    25% UNDECYLENIC ACID

    MAXIMUM STRENGTH

    Eliminates fungus on fingers, toes and around nails

    • Pre-filled pen with applicator brush
    • Convenient and easy to use
    • Dries quickly
    • Non-oily, clear formula

    NET 0.05 FL OZ (1.7mL)

    Anti-Fungal Nail Pen

  • INGREDIENTS AND APPEARANCE
    UNDECYLENIC ACID 
    antifungal pen liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-970
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    UNDECYLENIC ACID (UNII: K3D86KJ24N) (UNDECYLENIC ACID - UNII:K3D86KJ24N) UNDECYLENIC ACID25 mg  in 1.7 mL
    Inactive Ingredients
    Ingredient NameStrength
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49035-970-171.7 mL in 1 APPLICATOR; Type 0: Not a Combination Product05/01/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C05/01/2017
    Labeler - Wal-Mart Stores, Inc. (051957769)