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Undecylenic Acid by Harmon Store Inc.

Medically reviewed on December 21, 2017

Dosage form: liquid
Ingredients: Undecylenic Acid 7.5g in 30g
Labeler: Harmon Store Inc.
NDC Code: 63940-027

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.

Antifungal Liquid

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 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

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)

UNDECYLENIC ACID 
antifungal solution liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63940-027
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Undecylenic Acid (UNDECYLENIC ACID) Undecylenic Acid7.5 g  in 30 g
Inactive Ingredients
Ingredient NameStrength
ISOPROPYL PALMITATE 
Packaging
#Item CodePackage Description
1NDC:63940-027-1030 g in 1 BOTTLE, WITH APPLICATOR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C11/20/2013
Labeler - Harmon Store Inc. (804085293)

 
Harmon Store Inc.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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