Label: SIMPLY CLEAN INSTANT HAND SANITIZER- ethyl alcohol gel

  • 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 25, 2014

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  • ACTIVE INGREDIENT

    Active Ingredients
    Ethyl Alcohol 62%
  • PURPOSE

    Purpose
    Antimicrobial

  • INDICATIONS & USAGE

    KILLS MORE THAN 99.99% OF COMMON GERMS

  • WARNINGS

    WARNING:
    Flammable. Keep away from fire or flame.  FOR EXTERNAL USE ONLY. DO NOT USE IN THE EYES.

  • STOP USE

    DISCONTINUE USE IF IRRITATION AND REDNESS DEVELOP.
    IF CONDITION PERSISTS FOR MORE THAN 72 HOURS, CONSULT A DOCTOR.
  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN.

  • DOSAGE & ADMINISTRATION

    DIRECTIONS:
    Rub into skin until dry. 
    Other Information:
    Store below 110 F.

  • INACTIVE INGREDIENT

    INACTIVE INGREDIENTS:

    Inactive Ingredients: Water, Aloe barbadenis Leaf Juice, Glycerin,Propylene Glycol, Carbomer, Triethanolamine, Fragrance, Tocopheryl Acetate

  • PRINCIPAL DISPLAY PANEL

    image of bottle label
  • INGREDIENTS AND APPEARANCE
    SIMPLY CLEAN INSTANT HAND SANITIZER  
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53603-1009
    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)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53603-1009-244.3 mL in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E11/25/2014
    Labeler - BB17, LLC (828378294)
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