Otc - Active Ingredient
UNDECYLENIC ACID 25%
TOLNAFTATE 1%
Extra Strength Toenaiil Renewal Pen Liquid
FDA Label NDC 85966-010
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 Pen (NDC 85966-010). 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 athlete's 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
Clean and dry the affected nail and surrounding area.
Twist the pen base until the brush tip is saturated with essence.
Apply a thin layer to the entire nail, including the nail edges and underneath the nail crevices. Let it dy for 2-3 minutes.
Apply twice daily (morning and night) until a healthy nail has fully grown out.
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
DIMETHYL ISOSORBIDE
UREA
SALICYLIC ACID
MANUKA OIL
OREGANO LEAF OIL
TEA TREE OIL
CLOVE OIL
THYME OIL
ROSMARINUS OFFICINALIS (ROSEMARY) EXTRACT
CINNAMON OIL
KERATIN, TYPE I CYTOSKELETAL 18
BIOTIN
LEVOMENOL
CENTELLA ASIATICA WHOLE
TOCOPHEROL
MENTHOL
PROPANEDIOL
Package Label.Principal Display Panel
Label1 (Label1)
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