Label: BH HAND SANITIZER- ethanol gel

  • Category: HUMAN OTC DRUG LABEL

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 May 8, 2020

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient

    Alcohol 62% w/w

  • PURPOSE

    Purpose

    Antiseptic

  • INDICATIONS & USAGE

    Uses

    to help reduce bacteria on skin that can potentially cause disease.

  • WARNINGS

    Warnings

    For external use only. Flammable. Keep away from heat or flame.

    When using this product keep away from eyes. In case of eye contact, rinse eyes with water.

    Stop use and ask a doctor if irritation or redness develop or last more than 72 hours.

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

  • DOSAGE & ADMINISTRATION

    Directions

    • apply liberally to hands to cover all surfaces.
    • rub hands together until dry.
    • supervise children under 6 years old.
    • not recommended for infants.
  • STORAGE AND HANDLING

    Other information

    • Store between 15-30°C (59-86°F)
    • Avoid freezing and excessive heat above 40°C (104°F)
  • INACTIVE INGREDIENT

    Inactive ingredients

    Water, Polyquaternium 37, D-Limonene, Aloe vera leaf extract, fragrance, acrylate / alkyl acrylate polymerin C10 to C30, triethanolamine.

  • SPL UNCLASSIFIED SECTION

    Distributed by:

    M.C. Sales inc.

    Montreal Quebec 6636 Jeanne mance

    H2V 4L1 Canada

    1-888-643-2489

    MADE IN CANADA

  • PRINCIPAL DISPLAY PANEL

    BH
    HAND + SANITIZER
    ALCOHOL
    SANITIZER GEL
    8 fl oz (236 ml)

    Mid-City HS Final

  • INGREDIENTS AND APPEARANCE
    BH HAND SANITIZER 
    ethanol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77454-116
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
    POLYQUATERNIUM-37 (25000 MPA.S) (UNII: 31L31U8285)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77454-116-01236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/08/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E05/08/2020
    Labeler - Location Et Ventes de t.v. Mid-Cite (2001) Inc. (200031003)
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