Undecylenic Acid by Harmon Store Inc.
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.
Undecylenic acid 25%w/w
For cure of most tinea pedis (athete's foot) and tinea corporis (ringworm)
For relief of:
- discomforts which may accompany these conditons
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.
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
- 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
Principal Display Panel
Anti- Fungal Solution
Eliminates fungus on fingers, toes, and around nails
- Easy to apply
- Dries quickly
- Non-oily,clear formula
- Lightly scented
1 FL OZ (30mL)
antifungal solution liquid
|Product Type||HUMAN OTC DRUG||Item Code (Source)||NDC:63940-027
|Route of Administration||TOPICAL||DEA Schedule||
|Active Ingredient/Active Moiety
|Ingredient Name||Basis of Strength||Strength
|Undecylenic Acid (UNDECYLENIC ACID) ||Undecylenic Acid||7.5 g in 30 g
|#||Item Code||Package Description
|1||NDC:63940-027-10||30 g in 1 BOTTLE, WITH APPLICATOR
|Marketing Category||Application Number or Monograph Citation||Marketing Start Date||Marketing End Date
|OTC monograph final||part333C||11/20/2013||
|Labeler - Harmon Store Inc.
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.