Label: 3 HAND SANITIZERS- alcohol kit

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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 January 22, 2015

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  • Active Ingredient

    Alcohol 62%

    Purpose

    Antiseptic

  • Uses

    • Hand sanitizer to help decrease bacteria on the skin
    • recommended for repeat use
  • Warnings

    For External use only. Flammable. Keep away from fire or flame

    Do not apply around eyes, do not use in ears and mouth.

    When using this product

    avoid contact with eyes. In case of contact flush eyes with water.

    Stop use and ask a doctor

    if redness or irritation develop and persist for more than 72 hours

    Keep out or reach of children.

    Children must be supervised in use of this product.

  • Directions

    • Pump as needed into your palms and thoroughly spread on both hands.
    • rub into skin until dry.
  • Other information

    store at 20C-25C (68F to 77F)

    May discolor fabrics

  • Inactive Ingredients

    Aloe barbadensis gel, Carbomer, FDandC Blue No. 1 (for blue color fill item), FDandC Red No. 33, FDandC Yellow No. 5 (for brown color fill item), Fragrance, Glycerin, isopropyl myristate, Propylene glycol, tocopheryl acetate, triethanolamine, Water.

  • DESCRIPTION

    3 Hand Sanitizers

    Antibacterial gel - travel size

    1fl oz/29ml  -  Total 3fl oz / 87mL

    121403   1311

    Made in China
    Distributed by
    Greenbrier International, Inc.  500 Volvo Parkway, Chesapeake VA 23320

  • Product Labeling

    Hand Sanitizer

  • INGREDIENTS AND APPEARANCE
    3 HAND SANITIZERS 
    alcohol kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:40104-330
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:40104-330-011 in 1 KIT
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BOTTLE 29 mL
    Part 21 BOTTLE 29 mL
    Part 31 BOTTLE 29 mL
    Part 1 of 3
    OCEAN BREEZE HAND SANITIZER 
    alcohol gel
    Product Information
    Item Code (Source)NDC:40104-331
    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
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:40104-331-0129 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A01/03/2014
    Part 2 of 3
    EUCALYPTUS MINT HAND SANITIZER 
    alcohol gel
    Product Information
    Item Code (Source)NDC:40104-332
    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
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:40104-332-0129 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A01/03/2014
    Part 3 of 3
    CHERRY BLOSSOM HAND SANITIZER 
    alcohol gel
    Product Information
    Item Code (Source)NDC:40104-333
    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
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:40104-333-0129 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A01/03/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A01/03/2014
    Labeler - Ningbo Pulisi Daily Chemical Products Co.,Ltd. (529047265)
    Registrant - Ningbo Pulisi Daily Chemical Products Co.,Ltd. (529047265)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ningbo Pulisi Daily Chemical Products Co.,Ltd.529047265manufacture(40104-330)
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