Active Ingredient(S)
Tolnaftate 1%
Antifungal Pen Liquid
FDA Label NDC 84558-022
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 Yusong Fine Chemicls Co., Ltd for the product Antifungal Pen (NDC 84558-022). 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 active ingredient(s), purpose, use, warnings, 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
Purpose
Antifungal
Use
For the effective treatment of discoloration, thickening, splitting, crumbling and brittleness.
Cures most athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis).
Helps prevent most athlete's foot with daily use.
Provides effective relief of itching, scaling, cracking, burning, redness, soreness, irritation,
discomfort.
Warnings
For external use only.
Avoid contact with the eyes and mucous membranest.
ln the event of oversensitivity, stop using dermavia+Fungal Nail Treatment liquid.
Consult your doctor if there is no improvement within two weeks.
Consult your doctor before using if you are pregnant or are breastfeeding.
Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Do Not Use
on open wounds or damaged skin
Otc - When Using
avoid contact with eyes
do not apply to irritated or broken skin
use only as directed
Otc - Stop Use
If irritation occurs, stop using it immediately.
Otc - Keep Out Of Reach Of Children
Keep out of the reach of children. If swallowed, get medical help or contact a Poison
Control Center right away.
Directions
Before first use, twist the end of the pen until liquid appears on the applicator tip.
Clean the affected area and dry thoroughly.
Apply a thin layer of the product over affected area twice or three times daily, morning and
night, or as directed by a doctor.
This product is not effective on the scalp or nails.lf the condition persists longer, please
consult a doctor.
Other Information
Storage: Store in a dry and dark place at room temperature(5-25°C).
Inactive Ingredients
Argania Spinosa Kernel Oil, Melaleuca Alternifolia Leaf Oil,
Origanum Vulgare Oil, Prunus Amygdalus Dulcis Oil,Simmondsia Chinensis Seed Oil,
Tocopherol, Vitis Vinifera Seed Oil.
Package Label - Principal Display Panel
Undefined (Label)
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