Label: HI VETIC- tolnaftate ointment

  • NDC Code(s): 49873-056-01
  • Packager: Sato Pharmaceutical Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 6, 2023

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  • ACTIVE INGREDIENT

    Active ingredient    Tolnaftate 1%

  • 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

  • WARNINGS

    Warnings
    For external use only

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

    When using this product ■ avoid contact with the eyes

    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

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

  • DOSAGE & ADMINISTRATION

    Directions
    ■for the treatment 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

  • INACTIVE INGREDIENT

    Inactive ingredients  Carboxymethylcellulose sodium, diethyl sebacate, fragrance, glyceryl monostearate, lauromacrogol 400, light mineral oil, polyoxyethylene cetylether, potassium stearate, propylene glycol, simethicone, sodium lauryl sulfate, stearyl alcohol, urea, water, white wax, zinc oxide.

  • PRINCIPAL DISPLAY PANEL

    hiveticointcart.jpg Carton

  • INGREDIENTS AND APPEARANCE
    HI VETIC 
    tolnaftate ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49873-056
    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
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    DIETHYL SEBACATE (UNII: I41B9FJK6V)  
    POTASSIUM STEARATE (UNII: 17V812XK50)  
    CETETH-20 (UNII: I835H2IHHX)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    UREA (UNII: 8W8T17847W)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    POLIDOCANOL (UNII: 0AWH8BFG9A)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SILICON (UNII: Z4152N8IUI)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49873-056-011 in 1 CARTON10/25/1996
    115 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00510/25/1996
    Labeler - Sato Pharmaceutical Co., Ltd. (690575642)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sato Pharmaceutical Co., Ltd.715699133manufacture(49873-056) , label(49873-056) , pack(49873-056)