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 Chemco 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.
Otc - Active Ingredient
Undecylenic Acid 25%
Otc - Purpose
Antifungal
Uses:
Cures most athlete’s foot (tinea pedis) and ringworm (tinea corporis).
Relieves itching, scaling, cracking, burning, and redness.
Warnings
For external use only.
Do not use on children under 2 years of age unless directed by a doctor.
Extremely Flammable:
Keep away from fire or flame.
Otc - When Using
Avoid contact with eyes.
If contact occurs, rinse thoroughly with water.
Stop Use And Ask A Doctor If
Irritation occurs or if there is no improvement within 4 weeks.
Otc - Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away.
Directions:
Wash affected area and dry thoroughly. Apply a thin layer of the product over the affected area (around the nails and underneath nail tips) twice daily 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 change shoes and socks at least 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 15° - 30°C (59° - 86°F)
Inactive Ingredient
Isopropyl Alcohol, Aqua, Tocopheryl Acetate, DMDM Hydantoin, Melaleuca Alternifolia Leaf Oil.
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