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 Target Corporation. 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 (athlete's foot) and tinea corporis (ringworm).
For relief of:
- itching
- burning
- redness
- irritation
- scaling
- soreness
- discomfort which may accompany these conditions
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 warnings and directions. Use only as directed.
- clean the affected area and dry thoroughly
- apply a thin layer of the product over the affecter area twice daily (morning and night) or as directed by a doctor
- supervise children in the use of this product
- for athlete's foot: pay special attention to spaces between 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 conditions persists longer, consult a doctorthis product is not effective on the scalp or nails
Other Information
- store at room temperature 15°-30°C (59° - 86°F)
- protect from freezing. If freezing occurs warm to room temperature
- keep tightly closed when not in use
Inactive Ingredient
isopropyl palmitate
Questions?
Call 1-866-910-6874
Principal Display Panel
ront Panel
Compare to active ingredient in Fungi-Nail® anti-fungal solution*
maximum strength
antifungal pen
undecylenic acid
Eliminates fungus on fingers, toes and around nails
Topical solution with brush applicator
1 FL OZ (30mL)
Side Panel
Eliminates and helps stop the spread of fungal infections on cuticles, around nail edges, and under nail tips where reachable with applicator brush. Topical antifungal treatment will not penetrate hard nail surfaces.
*This product is not manufactured or distributed by Kramer Laboratories, Inc., owner of the registered trademark Fungi-Nail®.
* Please review the disclaimer below.