Otc - Active Ingredient
UNDECYLENIC ACID (25%)
TOLNAFTATE (1%)
Ssprotip X Extra Strength Toenail Renewal Solution Liquid
FDA Label NDC 85966-017
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 Ssprotip X Extra Strength Toenail Renewal Solution (NDC 85966-017). 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 ยท 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 nail 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 solution over affected area twice daily (morning and night). Supervise children in the use of this product.
Wait 2-3 minutes for the solution to be fully absorbed.
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 jock itch, use daily for 4 weeks. If condition persists longer, consult a doctor. This product is not effective on the scalp or nails.
Inactive Ingredient
UREA
ETHOXYDIGLYCOL
DIMETHYL SULFONE
LACTIC ACID
MANUKA OIL
CLOVE BUD OIL
EUCALYPTUS GLOBULUS LEAF OIL
TEA TREE OIL
OREGANO OIL
SALICYLIC ACID
SQUALANE
SIMMONDSIA CHINENSIS
BIOTIN
TOCOPHERYL ACETATE
AQUA
ETHYLHEXYLGLYCERIN
Package Label.Principal Display Panel
Label4 (Label4)
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