Otc - Active Ingredient
Undecylenic Acid 25%
Undecylenic Acid Liquid
FDA Label NDC 49283-025
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Chemco Corporation for the product Undecylenic Acid (NDC 49283-025). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, uses:, warnings, extremely flammable:, otc - when using, stop use and ask a doctor if, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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.
* Please review the disclaimer below.
