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TOENAIL FUNGUS TREATMENT Liquid
Toenail Fungus Treatment Liquid
FDA Label NDC 85038-002
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Lianjiang Shanlilai E-commerce Co., Ltd. for the product Toenail Fungus Treatment Liquid (NDC 85038-002). 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 other, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
TOLNAFTATE 1%
UNDECYLENIC ACID 25%
Otc - Purpose
Anti-fungal
Indications & Usage
For the effective treatment of nail fungus,discoloration,thickening,splitting,crum
bling and brittleness.
Warnings
For externat use only.
Otc - Do Not Use
chlldren under 2 years of age.
pregnant or if there is any allergic reaction to this produce.
Otc - When Using
When using this product Avoid contact with eyes.
Otc - Stop Use
Stop use and ask a doctor if lrritation occurs or discomfort persists.
Otc - Keep Out Of Reach Of Children
oif product gets Into eyes,flush with water for 15 minutes.
if swallowred,get medical help or contact a Poison Control Center rightaway.
Dosage & Administration
For initlal use, soak the affected part and soften the nalt in warm water.Gently remove dirt from the naiis, being careful not to damage the nail bed.
Apply full layers of nait solution with brush onto affected areas on ,around.and under nails,.A light tingle or burn is normal for the frst 10 minutes untilthe product is absorbed into the skin.
Apply the product twice a day, in the morning and at night.
Visible resuits will be seen in as little as 7 days, carry out regular use toprevent fungal growth.
Storage And Handling
Store betwseen 15° to 30 ° C (59° to 86 ° F)Avoid freezing and excessive heat above 40° C(104° F)
Inactive Ingredient
ALCOHOL
DIMETHICONE
CETOSTEARYL ALCOHOL
TEA TREE OIL
PROPYLENE GLYCOL
TOCOPHEROL
SAFFLOWER OIL
WATER
Package Label.Principal Display Panel
Label2 (Label2)
Label (Label1)
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