Active Ingredient(S)
Undecylenic Acid 25% w/w
Klipp Extra Strength Toenail Fungus Treatment Liquid
FDA Label NDC 84558-018
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Guangzhou Yusong Fine Chemicls Co., Ltd for the product Klipp Extra Strength Toenail Fungus Treatment (NDC 84558-018). 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(s), purpose, use, warnings, do not use, otc - when using, otc - stop use, 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
Purpose
Antifungal
Use
1. For the treatment of most athlete's foot (tinea pedis) and ringworm (tinea corporis)
2. Helps relieve symptoms associated with fungal nail infections, including itching, burning, and scaling
Warnings
For external use only
Do Not Use
- on children under 2 years of age
- on open wounds, irritated skin, or if you are allergic to any of the ingredients
- near the eyes, nose, or mouth
Otc - When Using
- avoid contactwith eyes. If contact occurs, rinse eyes thoroughly with water.
- do not use for more than 4 weeks unless directed by a doctor
Otc - Stop Use
- irritation or allergic reaction occurs
- condition worsens or does not improve after 4 weeks of use
- symptoms clear up and then return within a few days
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get
medical help or contact a Poison Control Center
immediately.
Directions
Clean and dry the affected area thoroughly before use.
Apply 2-3 drops (thin layer) to the affected nail(s) twice daily.
For best results, use consistently for the full treatment period.
Wash hands after application unless treating the hands.
Other Information
Store at 20°-25°C(68°-77°F)
Keep the cap tightly closed.
Do not use if the seal is broken or missing.
Inactive Ingredients
Aloe Vera Extract, Canola Oil, Clove Bud Oil,
Lavender Oil, Jojoba Oil, Manuka Oil, Oregano
Oil,Peppermint Oil, Propolis Extract, Sweet Almond
Oil, Tea Tree Oil, Tocophery| Acetate
Package Label - Principal Display Panel
Undefined (Label)
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