Label: BENGAMA ANTIFUNGAL- tolnaftate solution

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated February 17, 2023

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  • Active ingredient (in each gram)

    Tolnaftate 1%

  • Purpose

    Antifungal

  • Uses

    • clinically proven to cure most athlete's foot (tinea pedis) and ringworm (tinea corporis)
    • helps prevnet most athlete's foot from recurring when used daily
    • effectively soothes and relieves symptoms of athlete's foot, including itching, burning and cracking
  • Warnings

    For external use only

    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

    Do not use

    on children under 2 years of age except under the advice and supervision of a doctor.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • shake well before using
    • apply generously to affected areas and massage gently until liquid is absorbed into the skin
    • for adults and children over 12, rub well on the afffected area. repeat 3-4 times daily
    • for children 12 years of age or younger, consult a doctor before use
  • Inactive ingredients

    dehydrated ethyl alcohol, butylated hydroxytoluene, polyethylene glycol

  • Other information

    • store at controlled room temperature
  • Package label

    Bengama antifungal

    carton

  • INGREDIENTS AND APPEARANCE
    BENGAMA ANTIFUNGAL 
    tolnaftate solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69666-831
    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
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69666-831-041 in 1 BOX04/20/2015
    1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C04/20/2015
    Labeler - Genuine Drugs (079610378)
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