SKAPEMED SKIN REPAIR- tolnaftate 1% skin repair liquid

SKAPEMED SKIN REPAIR by

Drug Labeling and Warnings

SKAPEMED SKIN REPAIR by is a Otc medication manufactured, distributed, or labeled by Jiangxi Hemei Pharmaceutical Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Tolnaftate 1%

Purpose

Antifungal

Use

·Proven clinically effective in the treatment of most athlete's foot (tinea pedis)

·Helps prevent most athlete's foot with daily useFor effective reliefofitching, cracking, burning, scaling and discomfortRepairforskin eczemaRelief 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 orincinerate. 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

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

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, pseudolarix amabilis bark,salicylic acid,sophora flavescens root

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SKAPEMED SKIN REPAIR 
tolnaftate 1% skin repair liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84010-035
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV)	TOLNAFTATE	1 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
BENZOIC ACID (UNII: 8SKN0B0MIM)
PHELLODENDRON AMURENSE BARK (UNII: PBG27B754G)
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ)
PSEUDOLARIX AMABILIS BARK (UNII: 49G13A93VE)
SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K)
EUPHORBIA HIRTA WHOLE (UNII: L13YF113GN)
NIACINAMIDE (UNII: 25X51I8RD4)
VITAMIN A (UNII: 81G40H8B0T)
SALICYLIC ACID (UNII: O414PZ4LPZ)
LACTIC ACID (UNII: 33X04XA5AT)
ALCOHOL (UNII: 3K9958V90M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84010-035-01	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/09/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M005	10/09/2024

Labeler - Jiangxi Hemei Pharmaceutical Co., Ltd (724892056)

Establishment
Name	Address	ID/FEI	Business Operations
Jiangxi Hemei Pharmaceutical Co., Ltd		724892056	manufacture(84010-035)