FDA Label for Undecylenic Acid
View Indications, Usage & Precautions
Undecylenic Acid Product Label
The following document was submitted to the FDA by the labeler of this product Dolgencorp, Inc. (dollar General & Rexall). The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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
DG Health
Maximum Strength
Anti-Fungal Nail Solution
Undecylenic Acid 25%
- Eliminates fungus on fingers, toes and around nails
- Easy to apply appliator brush
- Dries quickly
- Non-oily, clear formula
- No unpleasant odor
Net Contents 1 FL OZ (30 mL)
* Please review the disclaimer below.