Label: BENGAMA - MICONAZOLE- miconazole nitrate 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 16, 2018

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

  • ´╗┐Drug Facts
  • ´╗┐Active ingredient

    MICONAZOLE 2%

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  • Purpose

    Antifungal

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  • 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.

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  • 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 and fatal. Help stop inhalant abuse, for more information, visit www.inhalant.org

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  • 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.

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  • 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.

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  • INGREDIENTS:

    Propellant, Ethanol, Talc, Fragrance.

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  • SPL UNCLASSIFIED SECTION

    MAXIMUM STRENGTH

    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

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  • Packaging
  • INGREDIENTS AND APPEARANCE
    BENGAMA -  MICONAZOLE
    miconazole nitrate aerosol, spray
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:69666-832
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE 20 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    PROPANE (UNII: T75W9911L6)  
    ISOBUTANE (UNII: BXR49TP611)  
    ALCOHOL (UNII: 3K9958V90M)  
    TALC (UNII: 7SEV7J4R1U)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:69666-832-04 1 in 1 BOX 11/01/2018
    1 128 g in 1 CAN; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part333C 11/01/2018
    Labeler - Genuine Drugs (079610378)
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