Label: UNDECYLENIC ACID- antifungal pen liquid

  • 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 December 1, 2017

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

  • Active ingredient

    Undecylenic acid 25%w/w

  • Purpose


  • 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 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

    maximum strength 

    antifungal nail pen

    25% undecylenic Acid

    eleminates fungus on fingers, toes and around nails

    prefilled applicator pen brush

    dries quickly

    0.10 Fl. OZ (3 mL)

    up&up_Antifungal Nail Pen_Box_0.10FLOZ-01.jpgup&up_Antifungal Nail Pen_0.10FLOZ-01.jpg

    up&up_Antifungal Nail Pen_Box_0.10FLOZ-01.jpgup&up_Antifungal Nail Pen_0.10FLOZ-01.jpg

    antifungal pen liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11673-634
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Undecylenic Acid (UNII: K3D86KJ24N) (UNDECYLENIC ACID - UNII:K3D86KJ24N) Undecylenic Acid25 mg  in 3 mL
    Inactive Ingredients
    Ingredient NameStrength
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11673-634-303 mL in 1 APPLICATOR; Type 0: Not a Combination Product02/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C02/01/2018
    Labeler - Target Corporation (006961700)