Label: 3 HAND SANITIZERS KIT- alcohol kit

  • 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 August 15, 2012

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  • ACTIVE INGREDIENT

    Active ingredient
    Ethyl Alcohol 62%
  • PURPOSE

    Purpose
    Antiseptic
  • INDICATIONS & USAGE

    Uses

    • hand sanitizer to help decrease bacteria on the skin.
    • recommended for repeat use.
  • WARNINGS

    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

    When using this product
    avoid contact with eyes. In case of contact flush eyes with water.
  • STOP USE

    Stop use and ask a doctor if redness or irritation develop and persist for more than 72 hours.
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. Children must be supervised in use of this product.
  • DOSAGE & ADMINISTRATION

    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 INGREDIENT

    Inactive Ingredients
    Aminomethyl propanol, Carbomer 940, FD&C Blue No. 1 (for winter wonderland scented, apple harvest scented & cherry blossom scented), FD&C Red No. 33 (for winter wonderland scented & apple harvest scented), FD&C Red No. 4(for cherry blossom scented), FD&C Yellow No. 5 (for winter wonderland scented, apple harvest scented & cherry blossom scented), Fragrance, Glycerin, Propylene glycol, Water.

  • PRINCIPAL DISPLAY PANEL

    image of kit label
    image of bottle label
  • INGREDIENTS AND APPEARANCE
    3 HAND SANITIZERS KIT 
    alcohol kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:33992-1500
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:33992-1500-31 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
    WINTER WONDERLAND SCENTED HAND SANITIZER 
    alcohol gel
    Product Information
    Item Code (Source)NDC:33992-1501
    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
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (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:33992-1501-129 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A08/15/2012
    Part 2 of 3
    CHERRY BLOOSOM SCENTED HAND SANITIZER 
    alcohol gel
    Product Information
    Item Code (Source)NDC:33992-1502
    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
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:33992-1502-129 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A08/15/2012
    Part 3 of 3
    APPLE HARVEST SCENTED HAND SANITIZER  
    alcohol gel
    Product Information
    Item Code (Source)NDC:33992-1405
    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
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (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:33992-1405-129 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/13/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A08/15/2012
    Labeler - Greenbrier International, Inc. (610322518)
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