Label: BENGAMA - TOLNAFTATE- tolnaftate aerosol, spray

  • 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 October 17, 2018

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  • Drug Facts

  • Active ingredient

    Tolnaftate 1 %

  • Purpose

    Antifungal

  • INDICATIONS & USAGE

    Foot Powder Spray instantly helps soothe, cool and comfort feet. Helps to absorb excess moisture a cause of athlete's foot. Use daily to help neutralize offensive foot odor.

  • CAUTION:

    CONTENTS UNDER PRESSURE. Do not expose to heat or open flame, or store at temperatures above 120°F (50°C). Do not spray near naked flame or incandescent material. Do not spray toward face. If eye contact occurs, rinse eyes well with water. If irritation persists, contact a physician. Do not intentionally inhale vapor or spray mist. Avoid contamination of food. Store in a cool dry space. Protect from direct sunlight. Dispose of container properly. Do not puncture or incinerate even when empty.

    USE ONLY AS DIRECTED: Intentional misuse by deliberately concentrating and inhaling the contents can be harmful fatal. Help stop inhalant abuse. for more information, visit www.inhalant.org

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN THE USER OF THIS PRODUCT ASSUMES ALL RISKS OD USE STORAGE. AND HANDLING NOT IN ACCORDANCE WITH ITS DIRECTIONS AND CAUTIONS.

  • DIRECTIONS:

    SHAKE CAN WELL BEFORE EACH USE.

    Hold about 6 inches away from feet. Spray generously on clean, dry feet and between toes. Use every day after bathing for results.

  • INGREDIENTS:

    Propellant, Ethanol, Talc, Fragrance.

  • SPL UNCLASSIFIED SECTION

    ATHLETE'S FOOT SPRAY

    COOL RELIEF

    ANTIFUNGAL SPRAY LIQUID

    Cools And Soothes Athletes Foot

    Fights Odor

    Manufactured for

    Genuine Drugs

    P.O.Box: 362111 San Juan PR 00936

    SEIN MENDEZ

    Quality you can trust

    MADE IN CHINA

  • Packaging

    image description

  • INGREDIENTS AND APPEARANCE
    BENGAMA -  TOLNAFTATE
    tolnaftate aerosol, spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69666-833
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV) TOLNAFTATE10 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PROPANE (UNII: T75W9911L6)  
    ISOBUTANE (UNII: BXR49TP611)  
    ALCOHOL (UNII: 3K9958V90M)  
    TALC (UNII: 7SEV7J4R1U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69666-833-041 in 1 BOX11/01/2018
    1128 g in 1 CAN; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C11/01/2018
    Labeler - Genuine Drugs (079610378)
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