Label: ONGO - FIN- tolnaftate liquid

  • NDC Code(s): 58593-800-01, 58593-800-02
  • Packager: Efficient Laboratories Inc.
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated May 20, 2024

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • ACTIVE INGREDIENT

    Active Ingredients:

    Tolnaftate 1% v/v........Antifungal

  • PURPOSE

    Uses:

    For effective treatment of Athlete's Foot (tinea pedis). For the relieve if itching, burning feet.

    Treatment for ringworm (tinea corporis). For the prevention of athlete's foot with daily use.

  • WARNINGS

    Warnings:

    Do not use on children under 2 years of age. Do not use for diaper rash. For external use only. Do not use if safety seal is broken or missing.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Flammable. Keep away from fire and flame.

  • DOSAGE & ADMINISTRATION

    Directions:

    • Clean the affected area with soap and water, dry thoroughly.
    • Apply a thin layer of Ongo Fin over the affected area twice daily (morning and night) or as directed by a physician.
    • For athlete's foot, pay special attention to spaces between the toes; wear well fitting, ventilated shoes, and change shoes and socks at least once daily.
    • For more effective results, continue applying Ongo Fin for 2 more weeks after the symptoms have disappeared.
    • Supervise children in the use if this product.
    • Ongo Fin is not effective on scalp or nails
    • Store between 15 - 30 degrees celcius ( 59 - 86 degrees farhenheit).
  • INDICATIONS & USAGE

    When using this product, avoid contact with eyes. Stop use and consult a doctor if irritation occurs or if there is no improvement within 4 weeks.

  • INACTIVE INGREDIENT

    Inactive Ingredients:

    Acetone, Aloe Vera Gel, Propylene Glycol, Purified Water and Tocopheryl Acetate (Vitamin E).


  • QUESTIONS

    Distributed By:

    Effecient laboratories, Inc.
    Miami FL 33166

    www.efficientlab.com

    (305) 805-3456  Monday to Friday 

    9:00am - 5:00pm EST

  • PRINCIPAL DISPLAY PANEL

    OngoFinLabel

  • INGREDIENTS AND APPEARANCE
    ONGO - FIN 
    tolnaftate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58593-800
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV) TOLNAFTATE1 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ACETONE (UNII: 1364PS73AF)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58593-800-0130 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product02/01/2004
    2NDC:58593-800-0230 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product02/01/200403/29/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00502/01/2004
    Labeler - Efficient Laboratories Inc. (969044932)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dextrum Laboratories Inc.007392322manufacture(58593-800)