Active Ingredient(S)
Undecylenic Acid 25%
Klipp Fungal Nail Treatment Liquid
FDA Label NDC 84558-019
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 Fungal Nail Treatment (NDC 84558-019). 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. Treats most athlete's foot (tinea pedis) and ringworm (tinea corporis)
2. Helps relieve itching, burning, scaling and discomfort associated with fungal skin infections
around the nail area
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
1. Clean and dry the affected area thoroughly before use.
2. Apply a thin layer to the affected nail(s) twice daily, morning and night.
3. For best results, use consistently for the full treatment period.
4. 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
Glycerin, Melaleuca Alternifolia (Tea Tree) Leaf Oil,
Phellodendron Amurense Bark Extract, Scutellaria
Baicalensis Root Extract, Sophora Flavescens Root Extract
Package Label - Principal Display Panel
Undefined (Label)
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