Otc - Active Ingredient
ARTEMISIA ARGYI LEAF, GINGER, TEA TREE OIL
Nail- Pflaster Patch
FDA Label NDC 84989-023
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Shantou Ximonth Biotechnology Co., Ltd. for the product Nail- Pflaster (NDC 84989-023). 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, otc - when using, warnings, otc - do not use, otc - stop use, otc - keep out of reach of children, storage and handling, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Quickly remove discolored nails; effectively soften thick nails; strengthen nails, restore normal thickness and enhance smoothness.
Otc - When Using
1. Clean and thoroughly dry the affected area before application. 2. Peel off the protective film, remove the release paper and then apply it to the affected area. 3. Wrap sides snugly and fold remaining adhesive. 4. Leave the patch on for at least 8 hours.
Warnings
Please keep out of reach of children. Do not swallow. Please clean your hands before use to ensure the best results from the product. Discontinue use if signs of irritation or rash occur. Store in a cool and dry place.
Otc - Do Not Use
Discontinue use if signs of irritation or rash occur.
Otc - Stop Use
Discontinue use if signs of irritation or rash occur.
Otc - Keep Out Of Reach Of Children
Please keep out of reach of children.
Storage And Handling
Store in a cool and dry place.
Inactive Ingredient
MINERAL OIL, MICROCRYSTALLINE WAX, 1,2-HEXANEDIOL, GLYCERIN
Indications & Usage
1. Clean and thoroughly dry the affected area before application. 2. Peel off the protective film, remove the release paper and then apply it to the affected area. 3. Wrap sides snugly and fold remaining adhesive. 4. Leave the patch on for at least 8 hours.
Dosage & Administration
1. Clean and thoroughly dry the affected area before application. 2. Peel off the protective film, remove the release paper and then apply it to the affected area. 3. Wrap sides snugly and fold remaining adhesive. 4. Leave the patch on for at least 8 hours.
Package Label.Principal Display Panel
Label (1)
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