Otc - Active Ingredient
Undecylenic Acid 25%
Tolnaftate 1%
Extra Strength Toenail Renewal Solution
FDA Label NDC 85966-013
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 Saweilan Import & Export Trading Co., Ltd for the product Extra Strength Toenail Renewal Solution (NDC 85966-013). 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
Antifungal
Indications & Usage
Helps improve the appearance of nails and supports the renewal of discolored or rough nal surfaces through mechanical and chemical exfoliating action.
Proven clinically effective in the treatment of most athletes foot (tinea pedis). jockich (tinea cruris), and ringworm (tinea corporis)
Relieves itching. scaling. cracking. burning, and discomfort associated with these conditions
Warnings
For external use only. Store in a cool place and avoid sunshine and heat.
Otc - Do Not Use
Do not use on children under 2 years of age unless directed by a doctor.
Otc - When Using
When using this product · avoid contact with the eyes or damaged skin.
Otc - Stop Use
Stop use and ask a doctor if · irritation occurs or if there is no improvement within 4 weeks.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away
Dosage & Administration
Clean the affected nal and dy thoroughly Fie the nallsurface to remove thickness After each use, wrap the nail file in a tissue and discard it (for single use only)
Use a dropper to apply and a cotton swab to spread evenly. If using a brush, replace it regularly
Apply a thin layer of the product over affected area twice daly morning and night Wait 2-3 minutes for the treamentto be fully absorbed.
Allow to dny.then wrap the afected toe with the antfungal bandage.For best resuts use overnight or before wearing shoestokeep the medication in place The bandage is self-adhesive.
TIPS:
For athlete's foot Pay special attention to spaces between the toes wear well-ftting ventilated shoes and change shoes and socks at least once daily
For athlete's foot and jock ich. use daily for a full4-week course Ifsymptoms persist. consut a doctor Not intended for use on the scalp or nails
This product is not effective on the scalp or nails.
Inactive Ingredient
Urea
Ethoxydiglycol
Lactic Acid
Melaleuca Ericifolia Leaf Oil
Eucalyptus Globulus Leaf Oil
Leptospermum Scoparium Branch/Leaf Oil
Origanum Vulgare Leaf Oil
Eugenia Caryophyllus (Clove) Bud Oil
Salicylic Acid
Simmondsia Chinensis Seed Oil
Tocopheryl Acetate
Biotin
Glycerin
Aqua
Package Label.Principal Display Panel
Label4 (Label4)
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