Label: INSTANT HAND SANITIZER BUBBLE GUM- 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 December 6, 2012

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  • ACTIVE INGREDIENT

    Active ingredients
    Ethyl Alcohol 62% v/v
  • 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:Water, Aloe barbadenis, Leaf Juice, Glycerin,

    Propylene Glycol, Carbomer, Triethanolamine, Fragrance, Tocopheryl Acetate, FD&C Red NO.33

  • PRINCIPAL DISPLAY PANEL

    image of bottle hangtag
  • INGREDIENTS AND APPEARANCE
    INSTANT HAND SANITIZER BUBBLE GUM  
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53603-2002
    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 (UNII: V5VD430YW9)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53603-2002-8236.6 mL in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E12/06/2012
    Labeler - BB17, LLC (828378294)
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