Otc - Active Ingredient
UNDECYLENIC ACID 25%
TOLNAFTATE 1%
Extra Strength Toenaiil Renewal Solution Liquid
FDA Label NDC 85966-011
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 Toenaiil Renewal Solution (NDC 85966-011). 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
For effective treatment of most athletes foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis)
For effective relief of itching, scaling, cracking, burning, redness, soreness, irritation, discomfort and
chafing associated with jock itch.
Proven effective in the prevention of most athlete's foot (tinea pedis) with daily use.
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
Wash the affected area and dry thoroughly. File the nail surface to remove thickness. Clean the nail file after each use.
Using a disposable cotton swab or dropper to apply.
Apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctor. Supervise children in the use of this product.
For athlete's foot Pay special attention to spaces between the toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once daily.
For athlete's foot and ringworm, use daily for 4 weeks; for jock itch, use daily for 2 weeks. If condition ​persists longer, consult a doctor. This product is not effective on the scalp or nails.
Inactive Ingredient
UREA
DIETHYLENE GLYCOL MONOETHYL ETHER
ALOE VERA LEAF
SALICYLIC ACID
TEA TREE OIL
OREGANO LEAF OIL
MANUKA OIL
ALLSPICE LEAF OIL
THYMUS VULGARIS (THYME) LEAF EXTRACT
BIOTIN
MENTHOL
JEEN VITAMIN E JEEN
LEVOMENOL
Package Label.Principal Display Panel
Label2 (Label2)
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