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Fungal Nail Renewal
Fungal Nail Renewal
FDA Label NDC 84019-201
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Shengnan (guangzhou) Cosmetics Co., Ltd for the product Fungal Nail Renewal (NDC 84019-201). 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 other, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
Undecenoic Acid 0.5%
Otc - Purpose
Sterilizing
Indications & Usage
RESTORES AND RENEWS
HYDRATES DAMAGED NAILS
Warnings
Do not use on children under 2 years of age unless directed by a doctor.
For external use only.
Avoid contact with the eyes.
Keep out of reach of children section.
Otc - Do Not Use
Do not use on children under 2 years of age unless directed by a doctor.
Otc - When Using
Avoid contact with eyes or mucous membranes.
Do not apply to wounds or damaged skin.
Do not use with other ointments, creams, sprays or liniments.
Otc - Stop Use
If swelling, blistering or other discomfort occurs,please stop using and consult doctor immediately.
If symptoms have not been relieved after using for more than 7 days, please stop using and consult doctor immediately.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children section.
Dosage & Administration
Apply two drops each time, 2-3 times a day, do not rinse with cold water within 2 hours after use.
Storage And Handling
Store in a cool dry place away from direct sunlight.
Inactive Ingredient
Glycerin
Propylene Glycol
Otassium Iodide
Menthol
Camellia Sinensis Seed Oil
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Label (Label)
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