Label: BT21 HAND SANITIZER- alcohol 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 September 22, 2020

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  • ACTIVE INGREDIENT

    Alcohol (70%)

  • INACTIVE INGREDIENTS

    Water, Triethanolamine, Glycerin, Carbomer, Polysorbate 20, Tocopheryl Acetate, Perfume

  • PURPOSE

    Antiseptic

  • WARNINGS

    For external use only
    Do not use if you are allergic to any of the ingredients
    When using this product Avoid contact with eyes. in case of contact, rinse eyes thoroughly with water. Avoid contact with broken, irritate. or itching skin.
    Stop use and ask a doctor if irritation or redness develops and condition persists for more than 72 hours.
    Keep out of reach of children. if swallowed, get medical help or contact a Poison Control Center(1-800-222-1222) right away.
    If pregnant or brest-feeding, ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. if swallowed, get medical help or contact a Poison Control Center(1-800-222-1222) right away.

  • Uses

    Hand sanitizer for decreasing bacteria on skin

  • Directions

    Apply the appropriate amount of the product onto your hands and spread it thoroughly.

    Rub hands together until it dries.

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of bottle

  • INGREDIENTS AND APPEARANCE
    BT21 HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78967-020
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL42 mL  in 60 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Glycerin (UNII: PDC6A3C0OX)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    Polysorbate 20 (UNII: 7T1F30V5YH)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78967-020-0160 mL in 1 BOTTLE; Type 0: Not a Combination Product09/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A09/01/2020
    Labeler - BALLON BLANC (089595089)
    Registrant - BALLON BLANC (089595089)
    Establishment
    NameAddressID/FEIBusiness Operations
    MYUNG COSMETIC688222692manufacture(78967-020)
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