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Undecylenic Acid by Harmon Store Inc.

Dosage form: liquid
Ingredients: UNDECYLENIC ACID 25mg in 1.7mL
Labeler: Harmon Store Inc.
NDC Code: 63940-003

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.

Harmon Antifungal Nail Pen

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 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 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 Facevalue

Maximum strength

Toe & Foot Anti-fungal Solution

Undecylenic acid

Pen applicator

Eliminates fungus on the fingers, toes and around nails

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

0.05 FL.OZ (1.7mL)

UNDECYLENIC ACID 
antifungal pen liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63940-003
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
UNDECYLENIC ACID (UNDECYLENIC ACID) UNDECYLENIC ACID25 mg  in 1.7 mL
Inactive Ingredients
Ingredient NameStrength
ISOPROPYL PALMITATE 
Packaging
#Item CodePackage Description
1NDC:63940-003-171.7 mL in 1 APPLICATOR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C02/18/2014
Labeler - Harmon Store Inc. (804085293)

 
Harmon Store Inc.

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Medically reviewed on Nov 28, 2017

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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