Label: HI VETIC- tolnaftate solution

  • NDC Code(s): 49873-050-02
  • Packager: Sato Pharmaceutical Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 1, 2023

If you are a consumer or patient please visit this version.

  • PURPOSE

    Purpose    Antifungal

  • INDICATIONS & USAGE

    Uses
    ■ for effective treatment of most athlete’s foot, jock itch, and ringworm ■prevents the recurrence of most athlete’s foot with daily use

    Do not use

    ■on children under 2 years of age unless directed by a doctor


  • WARNINGS

    Warnings
    For external use only
    Extremely flammable. Keep away from fire or flame

    When using this product

    ■avoid contact with the eyes


    Keep our of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

    Stop use and ask a doctor if

    ■irritation occurs

    ■there is no improvement within 4 weeks for athlete’s foot and ringworm, and within 2 weeks for jock itch

  • DOSAGE & ADMINISTRATION

    Directions
    ■for the tratment of athlete’s foot, jock itch, and ringworm
    ■cleanse the affected area with soap and water and dry throughly
    ■apply a thin layer of the product over affected area twice daily (morning and night), or as directed by a doctor
    ■to prevent athlete’s foot
    ■cleanse the feet with soap and water and dry throughly
    ■apply a thin layer of the product to the feet once or twice daily (morning and/or night)
    ■supervise children in the use of this product
    ■for athlete’s foot
    ■pay special attention to spaces between the toes
    ■wear well-fitting, ventilated shoes
    ■change shoes and socks at least once daily
    ■for athlete’s foot and ringworm, use daily for 4 weeks.
    ■for jock itch, use daily for 2 weeks.
    ■if condition persists longer, consult a doctor
    ■this product is not effective on the scalp or nails

  • OTHER SAFETY INFORMATION

    Other information   
    ■keep tightly closed
    ■cap bottle tightly and store at room temperature away from heat

  • INACTIVE INGREDIENT

    Inactive ingredients  acetone, citric acid, diethyl sebacate, fragrance, isopropyl alcohol, lauromacrogol 400, propyl gallate, water

  • ACTIVE INGREDIENT

    Active ingredient
    Tolnaftate 1%

  • PRINCIPAL DISPLAY PANEL

    hiveticsolncart.jpg Carton

  • INGREDIENTS AND APPEARANCE
    HI VETIC 
    tolnaftate solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49873-050
    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
    ACETONE (UNII: 1364PS73AF)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    DIETHYL SEBACATE (UNII: I41B9FJK6V)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    POLIDOCANOL (UNII: 0AWH8BFG9A)  
    PROPYL GALLATE (UNII: 8D4SNN7V92)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49873-050-021 in 1 CARTON08/14/1990
    120 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00508/14/1990
    Labeler - Sato Pharmaceutical Co., Ltd. (690575642)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sato Pharmaceutical Co., Ltd.715699133manufacture(49873-050) , label(49873-050) , pack(49873-050)