Active Ingredient
Tolnaftate 1%
Skapemed Skin Repair Liquid
FDA Label NDC 85248-054
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Jiangxi Yudexi Pharmaceutical Co., Ltd for the product Skapemed Skin Repair (NDC 85248-054). 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, purpose, use, warnings, do not use, when using, stop use, ask doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antifungal
Use
·Proven clinically effective in the treatment of most athlete's foot (tinea pedis) ·Helps prevent most athlete's foot with daily use ·For effective relief of itching, cracking, burning, scaling and discomfort
·Repair for skin eczema
·Relief acne and itching.
·Reduce tinea and herpes
Warnings
For external use only
Extremely Flammable do not use while smoking or near heat or flame. Do not use on children under 2 years of age unless directed by a doctor.When using this product avoid contact with the eyes ·Use only as directed.Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal .Do not puncture or incinerate. Contents under pressure. Do not store attemperatures above 120°F
Do Not Use
on children under 2 years of age unless directed by a doctor.
When Using
When using this product avoid contact with the eyes
Stop Use
·Irritation occurs
·There is no improvement within 4 weeks.
Ask Doctor
do not use while smoking or near heat or flame.Do not use on children under 2 years of age unless directed by a doctor.When using this product avoid contact with the eyes
Keep Oot Of Reach Of Children
If swallowed, get medical help or contact a poison control center right away.
Directions
·Wash the affected area and dry thoroughly ·Shake the can well. Apply a thin layer on the affected area twice a day (in the morning and at night). ·Supervise children in the use of this product ·Use daily for 4 weeks; if condition persists longer, ask a doctor ·This product is not effective on the scalp or nails.
Other Information
Store between 20-25°C(68-77°F)
Inactive Ingredients
Nicotinamide, lactic acid, vitamin A.alcohol, benzoic acid, euphorbia hirta whole,phellodendron amurense bark,phenylephrine hydrochloride, pseudol arix amabilis bark,salicylic acid,sophora flavescens root
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