HAND SANITIZER (ALCOHOL) GEL [KAREWAY PRODUCT, INC.]

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HAND SANITIZER (ALCOHOL) GEL [KAREWAY PRODUCT, INC.]
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NDC 67510-0487-2, 67510-0487-8
Set ID a1c9c574-2dbb-438c-a8de-569d15f51460
Category HUMAN OTC DRUG LABEL
Packager Kareway Product, Inc.
Generic Name
Product Class
Product Number
Application Number PART333E
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  • Active Ingredient

    Ethyl Alcohol  62%    

  • Purpose

    Antiseptic

  • Keep out of reach of children

    In case of a accidental ingestion, seek professional assistance or contact a Poison control Center immediately.

  • Uses

    • To decrease bacteria on the skin.
    • Recommended for repeated use.
  • Warnings

    For external use only-hands.
    Flammable. Keep away from hear or flame.

    When using this product

    • Keep out of eyes. In case of contact with eyes, flush throughly with water.
    • Avoid contact with broken skin.

    Stop use and ask a doctor if

    skin irritation developes

  • Directions

    • Wet hands throughly with product and allow to dry without wiping.
    • For children under 6, use only under adult supervision
    • Not recommended for infants.
  • Other information

    • Store at 20° to 25°C (68° to 77°F)
  • Inactive Ingredients

    Water, Glycerin, Propylene Glycol, Carbomer, Fragrance, Isopropyl Alcohol, Sodium Hydroxide, Isopropyl Myristate, Tocopheryl Acetate, Aloe Vera Extract

  • PRINCIPAL DISPLAY PANEL

    image of bottle label

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67510-0487
    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
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67510-0487-22 in 1 BLISTER PACK
    159.2 mL in 1 BOTTLE
    2NDC:67510-0487-81 in 1 BLISTER PACK
    2236 mL in 1 BOTTLE, PUMP
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E10/07/2013
    Labeler - Kareway Product, Inc. (121840057)
    Registrant - Ningbo Pulisi Daily Chemical Products Co., Ltd. (529047265)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ningbo Pulisi Daily Chemical Products Co., Ltd.529047265manufacture(67510-0487)
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