Label: BAK-OFF HAND SANITIZER 70 PERCENT- ethyl alcohol gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 March 29, 2022

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  • ACTIVE INGREDIENT

    ETHYL ALCOHOL 70%

  • PURPOSE

    ANTISEPTIC

  • USES

    TO DECREASE BACTERIA ON THE SKIN

    RECOMMENDED FOR REPEATED USE

  • WARNINGS

    FOR EXTERNAL USE ONLY (HANDS).

    FLAMMABLE, KEEP AWAY FROM FIRE OR FLAME.

    WHEN USING THIS PRODUCT

    • KEEP OUT OF EYES. IN CASE OF CONTACT WITH EYES, FLUSH THOROUGHLY WITH WATER.
    • AVOID CONTACT WITH BROKEN SKIN
    • DO NOT INHALE OR INHEST

    STOP USE AND ASK A DOCTOR IF

    • IRRITATION AND REDNESS DEVELOP
    • CONDITION PERSISTS FOR MORE THAN 72 HOURS
  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN.

    IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

  • DIRECTIONS

    WET HANDS THOROUGHLY WITH PRODUCT AND ALLOW TO DRY WITHOUT WIPING

    • FOR CHILDREN UNDER 6, USE ONLY UNDER ADULT SUPERVISION
    • NOT RECOMMENDED FOR INFANTS
  • OTHER INFORMATION

    DO NOT STORE ABOVE 105°F

    • MAY DISCOLOR SOME FABRICS
    • HARMFUL TO WOOD FINISHES AND PLASTICS
  • INACTIVE INGREDIENTS

    WATER, ALOE BARBADENSIS LEAF JUICE, GLYCERIN, ISOPROPYL MYRISTATE, LAVANDULA ANGUSTIFOLIA (LAVENDER) OIL, ROSMARINUS OFFICINALIS (ROSEMARY) LEAF OIL, PELARGONIUM GRAVEOLENS (GERANIUM) FLOWER OIL, CARBOMER, TOCOPHERYL ACETATE, AMINOMETHYL PROPANOL

  • PRINCIPAL DISPLAY PANEL

    01b LBL_Bak Off_100mL

  • INGREDIENTS AND APPEARANCE
    BAK-OFF HAND SANITIZER   70 PERCENT
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50518-305
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    ROSEMARY OIL (UNII: 8LGU7VM393)  
    GERANIUM OIL, ALGERIAN TYPE (UNII: 5Q1I94P4WG)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50518-305-11100 mL in 1 BOTTLE; Type 0: Not a Combination Product05/25/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/25/2020
    Labeler - CUSTOM RESEARCH LABS INC (028611598)
    Registrant - CUSTOM RESEARCH LABS INC (028611598)
    Establishment
    NameAddressID/FEIBusiness Operations
    CUSTOM RESEARCH LABS INC028611598manufacture(50518-305)
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