HAND SANITIZER GEL (ETHYL ALCOHOL) GEL [BB17, LLC]

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HAND SANITIZER GEL (ETHYL ALCOHOL) GEL [BB17, LLC]
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NDC 53603-1051-1
Set ID 70ed0eab-558c-93dc-e053-2a95a90ae36e
Category HUMAN OTC DRUG LABEL
Packager BB17, LLC
Generic Name
Product Class
Product Number
Application Number PART333E
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  • ACTIVE INGREDIENT

    Active Ingredient:
    Ethyl Alcohol 62%

  • PURPOSE

    Purpose:
    Antimicrobial

  • WARNINGS

    WARNING:
    FLAMMABLE. KEEP AWAY FROM FIRE OR FLAME.     FOR EXTERNAL USE ONLY.DO NOT USE IN THE EYES.

  • STOP USE

    DISCONTINUE USE IF IRRITATION AND REDNESS DEVELOP.
    IF CONDITION PERSISTS FOR MORE THAN 72 HOURS, CONSULT A DOCTOR OR PHYSICIAN.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN.

  • DOSAGE & ADMINISTRATION

    Directions:
    Rub into hands until dry.

  • INACTIVE INGREDIENT

    Water, Aloe barbadenis Leaf Juice, Glycerin,Propylene Glycol, Olive Oil, Fragrance, Carbomer, Triethanolamine, FD&C Blue No.1, D&C Red No.33.

  • STORAGE AND HANDLING

    Other Information:
    Store below 110 F.

  • INDICATIONS & USAGE

    KILLS MORE THAN 99.99% OF COMMON GERMS

  • PRINCIPAL DISPLAY PANEL

    image of bottle label

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER GEL 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53603-1051
    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
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53603-1051-129.5 mL in 1 BOTTLE; Type 0: Not a Combination Product07/14/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E07/14/2018
    Labeler - BB17, LLC (828378294)
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