Label: BAMA-BIO TECH HAND SANITIZER 80 ETHANOL UNSCENTED- alcohol liquid

  • 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 January 5, 2022

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  • DRUG FACTS

  • ACTIVE INGREDIENT[S]

    ALCOHOL 80% v/v

    PURPOSE

    ANTISEPTIC

  • USE[S]

    HEALTHCARE PERSONNEL HAND SANITIZER TO HELP REDUCE BACTERIA AND VIRUSES THAT POTENTIALLY CAN CAUSE DISEASE.

  • WARNINGS

    FOR EXTERNAL USE ONLY. FLAMMABLE. KEEP AWAY FROM HEAT OR FLAME. HARMFUL OR FATAL IF SWALLOWED.

    DO NOT USE

    • ON CHILDREN UNDER 2 MONTHS OF AGE
    • ON OPEN SKIN WOUNDS

    WHEN USING THIS PRODUCT

    KEEP OUT OF EYES, EARS, AND MOUTH. IN CASE OF CONTACT WITH EYES, RINSE EYES THOROUGHLY WITH WATER.

    STOP USE AND CONTACT A PHYSICIAN

    IF IRRITATION OR RASH OCCUR.

    KEEP OUT OF REACH OF CHILDREN

    IF SWALLOWED, CALL POISON CONTROL IMMEDIATELY.

  • DIRECTIONS

    PLACE PRODUCT ON HANDS TO COVER ALL SURFACES. THOROUGHLY RUB HANDS TOGETHER UNTIL DRY. SUPERVISE USE WITH CHILDREN UNDER 6 YEARS OF AGE.

  • OTHER INFORMATION

    STORE BETWEEN 15-30°C (59-86°F)

  • INACTIVE INGREDIENTS

    GLYCERIN, HYDROGEN PEROXIDE, PURIFIED WATER USP

  • Package Labeling:128oz/3.78L

    Label

  • Package Labeling:16oz/473.2mL

    Label2

  • Package Labeling:8oz/236.6mL

    Label3

  • Package Labeling:4oz/118.3mL

    Label4

  • INGREDIENTS AND APPEARANCE
    BAMA-BIO TECH HAND SANITIZER 80 ETHANOL UNSCENTED 
    alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:90085-000
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.8 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:90085-000-013780 mL in 1 BOTTLE; Type 0: Not a Combination Product07/31/2020
    2NDC:90085-000-02473.2 mL in 1 BOTTLE; Type 0: Not a Combination Product07/31/2020
    3NDC:90085-000-03236.6 mL in 1 BOTTLE; Type 0: Not a Combination Product07/31/2020
    4NDC:90085-000-04118.3 mL in 1 BOTTLE; Type 0: Not a Combination Product07/31/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E07/31/2020
    Labeler - Bama-Bio Tech Corporation (117525750)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bama-Bio Tech Corporation117525750manufacture(90085-000)
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