HAND SANITIZER (ALCOHOL) GEL [PERSONAL CARE PRODUCTS]

HAND SANITIZER (ALCOHOL) GEL [PERSONAL CARE PRODUCTS]
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NDC 29500-909-58
Set ID f51e20ac-e45d-42ad-b042-c9997f3af047
Category HUMAN OTC DRUG LABEL
Packager Personal Care Products
Generic Name
Product Class
Product Number
Application Number PART333A
  • ACTIVE INGREDIENT



    Active Ingredient   Ethyl Alcohol 62.0%

  • PURPOSE



    Purpose  Antimicrobial

  • KEEP OUT OF REACH OF CHILDREN



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

  • INDICATIONS & USAGE



    Uses hand sanitizer to help reduce bacteria on the skin.

  • WARNINGS



    Warnings

    For external use only.

    Flammable. Keep away from heat and flame.

    When using this product avoid contact with face, eyes, and broken skin. In case of eye contact, flush with plenty of water and seek medical advice.

  • DOSAGE & ADMINISTRATION



    Directions

    Wet hands thoroughly with product and rub into skin until dry.

    Children under 6 years of age should be supervised by an adult when using this product.

  • INACTIVE INGREDIENT



    Inactive ingredients

    aloe barbadensis leaf juice, carbomer, fragrance, glycerin, propylene glyol, tocopheryl acetate (vitamin E), triethanolamine, water (aqua)

  • PRINCIPAL DISPLAY PANEL

    label


    Personal Care

    Kills 99.9% of germs*

    Hand sanitizer

    Antibacterial

    with Moisturizers and Vitamin E

    8 fl oz (236 ml)

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:29500-909
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    alcohol (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) alcohol146.3 mL  in 236 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:29500-909-58236 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A08/01/2011
    Labeler - Personal Care Products (966155082)
    Registrant - Personal Care Products (966155082)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ningbo United Group Co Ltd528196956manufacture

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