Active Ingredient
Undecylenic Acid 25%
The following Structured Product Label (SPL) was submitted to the FDA by Jiangxi Yudexi Pharmaceutical Co., Ltd for the product Kakalsa Toenail Fungus Treatment (NDC 85248-204). 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 active ingredient, purpose, use, warnings, do not use, when using, stop use, ask doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Undecylenic Acid 25%
Antifungal
Cures most Athlete's Foot (Tinea Pedis) and Ringworm (Tinea Corporis). Relieves itching, scaling, cracking, burning, redness, soreness, and irritation and discomfort. Helps prevent most athlete's foot (dermatophytosis) with daily use.
For external use only.
·On children under 2 years of age unless directed by a doctor.
·If you're pregnant, breastfeeding, or any allergic reaction occurs.
·Avoid contact with eyes.
·If contact occurs, immediately rinse thoroughly with water or seek medical advice if necessary.
·Irritation occurs.
·No improvement if you have persisted in using it for 4 weeks.
·Irritation occurs.
·No improvement if you have persisted in using it for 4 weeks.
·If swallowed, get medical help or contact a Poison Control Center right away.
For athlete's foot and ringworm:
use daily for 4 weeks. Clean the affected area and dry thoroughly. Apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctor. Supervise children in the use of this product. This product is not effective for the treatment of ring worm of the scalp or nails.
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. To prevent athlete's foot, apply once or twice daily (morning and/or night). Apply to skin around the nail and cuticle.
Store at 15°–30° (59°–86°F) and out of direct sunlight.
Purified Water, Aloe Vera Extract, Tea Tree Oil, Clove Bud Oil, Lavender Oil, Jojoba Oil, Manuka Oil, Peppermint Oil, Oregano Leaf Oil, Propolis, Almond Oil, Alpha-Tocopherol, Acetate (Vitamin E).
* Please review the disclaimer below.