FDA Label for Undecylenic Acid Liquid
View Indications, Usage & Precautions
Undecylenic Acid Liquid Product Label
The following document was submitted to the FDA by the labeler of this product Premier Brands Of America Inc.. 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
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 doctor
- this product is not effective on the scalp or nails
Other Information
- store at room temperature 15°-30°C (59° - 86°F)
Inactive Ingredient
isopropyl palmitate
Questions?
Call 1-866-964-0939
Principal Display Panel
Premier Brands
Maximum Strength
Anti-Fungal Liquid
25% Undecylenic acid
Eliminates fungus on fingers, toes and around nails.
Easy to apply applicator brush
Dries quickly
Non-oily, clear formula
No unpleasant odor
Net Contents: 1 FL OZ (30 mL)
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