Label: 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 October 8, 2013

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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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