Otc - Active Ingredient
Active Ingredient
Tolnaftate 1%
Nail Lab Fungomer Nailelixir Oil
FDA Label NDC 84222-002
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Foshan Miwei Cosmetics Co., Ltd. for the product Nail Lab Fungomer Nailelixir (NDC 84222-002). 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.
Label Section Quick Index
Otc - Purpose
Purpose
Antifungal
Indications & Usage
Uses
- For all caused by nail fungus
- Nail discoloration
- Nail thickening
- Nail splitting
- Nail crumbling
Warnings
Warnings
- External Use Only.
- Avoid contact with eyes and mouth.
- If contact occurs, rinse immediately.
- Test on a small skin area 24 hours before full use.
- Discontinue if irritation occurs. Keep out of reach of children.
- If pregnant or nursing, seek medical advice before use.
- Avoid mixing with other products.
- Check the expiry date.
- Do not apply to broken or inflamed skin.
Otc - Do Not Use
Do not apply to broken or inflamed skin.
Otc - When Using
- Avoid contact with eyes and mouth.
- If contact occurs, rinse immediately.
- Test on a small skin area 24 hours before full use.
Otc - Stop Use
Discontinue if irritation occurs.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Otc - Pregnancy Or Breast Feeding
If pregnant or nursing, seek medical advice before use.
Dosage & Administration
Directions:
- Soak your nails in warm water for 10-15 minutes.
- Gently dry the needed area using a clean paper towel.
- Use the nail file to remove the soft part of the nail.
- Apply a few drops of oil on the needed area using the pipette.
- Spread the liquid over the cuticles and nearby skin using the brush.
- Gently massage the solution into the needed area.
- Allow the solution to absorb for 10-1 5 minutes. Avoid contact with eyes and mouth.
- Repeat 3 times a day. Recommended to leave on overnight.
- Travel Pen: Rotate the top clockwise to dispense the solution. Designed for your convenience, making every trip easier.
Storage And Handling
Store in a cool, dry place, away from direct sunlight.
Other Safety Information
Other information:
- Store in a cool, dry place, away from direct sunlight.
- Ensure nail enhancement equipment is sterilized prior to each application.
- Utilize only uncontaminated and sanitized supplies.
- Maintain nails by keeping them neatly trimmed and devoid of any accumulated debris.
- Should any concerns arise, seek professional medical consultation. promptly.
Inactive Ingredient
Inactive Ingredients:
Vitis Vinifera Seed Oil, Simmondsia Chinensis Seed Oil, Prunus Amygdalus Dulcis Oil, Argania Spinosa Kernel Oil, Melaleuca Alternifolia Leaf Oil, Tocopherol, Origanum Vulgare Oil.
Otc - Questions
Questions?
Email: support @ nail-lab.co
* Please review the disclaimer below.
