Label: NEKVNRO FUNGAL NAIL- tolnaftate 1% fungal nail ointment

  • NDC Code(s): 84010-029-01, 84010-029-02, 84010-029-03, 84010-029-04
  • Packager: Jiangxi Hemei Pharmaceutical Co., Ltd
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated September 11, 2024

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  • Active Ingredient

    Tolnaftate 1%

  • Purpose

    Anti-fungal

  • Use

    ●Proven effective in the treatment of most athlete's foot (tinea pedis)and ringworm(tinea corporis)..

    ● Helps prevent most athlete's foot with daily use.

    ● For effective relief of itching, burning and cracking.

  • Warnings

    Forexternal use only

  • Do not use

    Do not use on children under 2 years of age unless directed by a doctor

  • When Using

    When using this product avoid contact with eyes.

  • Stop Use

    ●lrritation occurs

  • Ask Doctor

    ● There is no improvement within 4 weeks.

  • Keep Oot Of Reach Of Children

    In case of accidental ingestion, contact a physician, emergency medical carefacility or Poison Control Centerimmediately for advice.

  • Directions

    ●Clean affected areas with soap and warm water and dry thoroughly.● Apply a thin layer of Anti-Fungal Ointment over affected area twice daily(morning and night) or as directed by a doctor.●Wear well-fitting, ventilated shoes, and change shoes and socks at least once daily.

    ●For athlete's foot pay special attention to spaces between the toe.

    ●For athlete's foot and ringworm.use daily for 4 weeks.

    ●To prevent athlete's foot, apply once or twice daily(morning and/or night).

    ●For toe fungus, apply under nail and around cuticl earea. lf condition persists longer, consult a doctor. ●This product is not effectiveon the scalp or nails.

    ●Supervise children in the use of this product.

  • Other information

    Store at controlled room temperature 15°-30℃( 59°-86°F) Protect from freezing If freezing occurs warm to room temperature.

  • Inactive ingredients

    Cetyl alcohol,Glycerin, Monoolein, Salicylic acid,Stearyl alcohol, Urea, Aceticacid,mineral oil, etc.

  • PRINCIPAL DISPLAY PANEL

    123

  • INGREDIENTS AND APPEARANCE
    NEKVNRO FUNGAL NAIL 
    tolnaftate 1% fungal nail ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84010-029
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV) TOLNAFTATE1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    SALICYLIC ACID (UNII: O414PZ4LPZ)  
    GLYCERYL MONOOLEATE (UNII: C4YAD5F5G6)  
    UREA (UNII: 8W8T17847W)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    ACETIC ACID (UNII: Q40Q9N063P)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84010-029-0120 g in 1 TUBE; Type 0: Not a Combination Product09/11/2024
    2NDC:84010-029-0230 g in 1 TUBE; Type 0: Not a Combination Product09/11/2024
    3NDC:84010-029-0342.5 g in 1 TUBE; Type 0: Not a Combination Product09/11/2024
    4NDC:84010-029-0450 g in 1 TUBE; Type 0: Not a Combination Product09/11/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00509/11/2024
    Labeler - Jiangxi Hemei Pharmaceutical Co., Ltd (724892056)
    Establishment
    NameAddressID/FEIBusiness Operations
    Jiangxi Hemei Pharmaceutical Co., Ltd724892056manufacture(84010-029)
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