Label: SKAPEMED SKIN REPAIR- tolnaftate 1% skin repair liquid

  • NDC Code(s): 84010-035-01
  • Packager: Jiangxi Hemei Pharmaceutical Co., Ltd
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated October 8, 2024

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  • 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

    1

  • INGREDIENTS AND APPEARANCE
    SKAPEMED SKIN REPAIR 
    tolnaftate 1% skin repair liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84010-035
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV) TOLNAFTATE1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84010-035-0150 mL in 1 BOTTLE; Type 0: Not a Combination Product10/09/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00510/09/2024
    Labeler - Jiangxi Hemei Pharmaceutical Co., Ltd (724892056)
    Establishment
    NameAddressID/FEIBusiness Operations
    Jiangxi Hemei Pharmaceutical Co., Ltd724892056manufacture(84010-035)