Otc - Active Ingredient
Undecylenic Acid (25%)
The following Structured Product Label (SPL) was submitted to the FDA by Guangzhou Xinhongda Trading Service Co., Ltd. for the product Lqnzjbau Nail Repair Pen (NDC 87681-006). 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, indications & usage, warnings, otc - 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.
Undecylenic Acid (25%)
Antifungal
For the relief of itching, burning, and irritation associated with these conditions.
Helps in the treatment of antifungal infections on skin around nails.
For external use only.
Do not use on children under 2 years of age unless directed by a doctor.
Avoid contact with eyes. If contact occurs, rinse thoroughly with water.
·Stop use and ask a doctor if irritation occurs or there is no improvement within 4 weeks.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Clean and dry affected area.
Apply a thin layer twice daily (morning and night)
Continue treatment for at least 4 weeks. For nail fungus, treatment may be required for 8-12 weeks.
ALCOHOL
WATER
UREA
PROPYLENE GLYCOL
SALICYLIC ACID
MENTHOL
HYDROXYPROPYLCELLULOSE
ZANTHOXYLUM BUNGEANUM FRUIT EXTRACT
MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL
DISODIUM EDTA
GLYCOLIC ACID
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