Label: HEALTH SMART INSTANT HAND SANITIZER WITH ALOE VERA AND VITAMIN E LAVENDER- alcohol solution

  • 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 December 24, 2013

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  • Drug Facts

    Active Ingredients

    Ethyl Alcohol 65%

  • 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.
  • Inactive ingredients

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

  • SPL UNCLASSIFIED SECTION

    MADE IN CHINA.

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

    * This product is not manufactured or distributed by Gojo Industries, Inc, distributor of the registered trademark Purell®

  • Package Label

    HEALTH SMARTTM
    Kills 99.99% of Germs
    INSTANT
    HAND
    SANITIZER
    with aloe vera & vitamin e
    Lavender
    *Same Active ingredient as Purell® Hand Sanitizer
    8 fl oz [237 mL]

    Label

  • INGREDIENTS AND APPEARANCE
    HEALTH SMART INSTANT HAND SANITIZER WITH ALOE VERA AND VITAMIN E LAVENDER 
    alcohol solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52862-303
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL65 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:52862-303-0260 mL in 1 BOTTLE
    2NDC:52862-303-08237 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E12/24/2013
    Labeler - International Wholesale, Inc. (161872676)
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