Label: UNDECYLENIC ACID- antifungal pen liquid

  • NDC Code(s): 41250-087-17
  • Packager: Meijer Distribution 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 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 the cure of most tinea pedis (athlete's foot) and tinea corporis (ringworm)
    For relief of:

    • itching
    • burning
    • redness
    • irritation
    • scaling
    • discomfort 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 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 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 150 - 300C (590 - 860F)
    • 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

    meijer

    anti-fungal pen

    Undecylenic Acid

    Maximum Strength

    Eliminates Fungus on Fingers, Toes & Around Nails

    Pre-filled pen with

    applicator brush

    Convenient & easy-to-use

    Dries quickly

    Non-oily, clear formula

    NET CONTENTS 0.06 FL. OZ (1.7 mL)

    anti fungal pen

  • INGREDIENTS AND APPEARANCE
    UNDECYLENIC ACID 
    antifungal pen liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41250-087
    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:41250-087-171.7 mL in 1 APPLICATOR; Type 0: Not a Combination Product03/19/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C03/19/2014
    Labeler - Meijer Distribution Inc (006959555)