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 November 15, 2014

If you are a consumer or patient please visit this version.

  • Drug Facts

    Active Ingredients

    Ethyl Alcohol 62%

  • Purpose

    Antimicrobial

  • Uses

    • helps reduce bacteria on the skin that could cause disease
    • Recommended for repeated use
  • Warnings

    For external use only.

    Flammable. Keep away from fire or flame.

  • WHEN USING

    When using this product do not use in or near the eyes. In case of eye contact, rinse eyes thoroughly with water.

  • STOP USE

    Stop use and ask a doctor if: irritation and redness develops and lasts more than 72 hours.

  • KEEP OUT OF REACH OF CHILDREN

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

  • Directions

    • Place enough product in your palm to thoroughly cover your hands
    • Rub hands together briskly until dry
    • Children under 6 years of age should be supervised when using this product.
  • Other information

    • Store below 110°F (43°C)
    • May discolor certain fabrics or surfaces.
  • cucumber melon

    Inactive ingredients Water, Aloe Barbadensis Gel, Carbomer, Glycerin, Triethanolamine, Tocopheryl Acetate, FD&C Yellow No. 5, FD&C Blue No.1

  • sweet pea

    Inactive ingredients Water, Aloe Barbadensis Gel, Carbomer, Glycerin, Triethanolamine, Tocopheryl Acetate, D&C Red No. 33, FD&C Blue No.1

  • peach

    Inactive ingredients Water, Aloe Barbadensis Gel, Carbomer, Glycerin, Triethanolamine, Tocopheryl Acetate, FD&C Red No. 40, FD&C Yellow No. 5

  • SPL UNCLASSIFIED SECTION

    MADE IN CHINA.

    DISTRIBUTED BY:
    homesmartTM
    PRODUCTS
    SOUTHFIELD, MI 48075
    WWW.HOMESMARTPRODUCTS.COM

    NOT FOR INDIVIDUAL SALE

  • PRINCIPAL DISPLAY PANEL

    HEALTH SMARTTM
    3 HAND SANITIZERS
    • with aloe vera & vitamin e •travel size
    1 fl oz/29 ml • Total 3 fl oz/ 87 mL

    image of bottle labelimage of kit label

  • INGREDIENTS AND APPEARANCE
    3 HAND SANITIZERS 
    alcohol kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52862-412
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52862-412-871 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
    HEALTH SMART INSTANT HAND SANITIZER WITH ALOE VERA AND VITAMIN E CUCUMBER MELON 
    alcohol solution
    Product Information
    Item Code (Source)NDC:52862-401
    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)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52862-401-0129 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A11/15/2014
    Part 2 of 3
    HEALTH SMART INSTANT HAND SANITIZER WITH ALOE VERA AND VITAMIN E SWEET PEA 
    alcohol solution
    Product Information
    Item Code (Source)NDC:52862-402
    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)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52862-402-0129 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A11/15/2014
    Part 3 of 3
    HEALTH SMART INSTANT HAND SANITIZER WITH ALOE VERA AND VITAMIN E PEACH 
    alcohol solution
    Product Information
    Item Code (Source)NDC:52862-404
    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)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52862-404-0129 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A11/15/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A11/15/2014
    Labeler - International Wholesale, Inc. (161872676)