Label: BARBIE 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 June 23, 2020

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  • Drug Facts

  • Active Ingredients

    Ethyl Alcohol 62% v/v

  • Purpose

    Antiseptic

  • Use:

    To help reduce bacteria and germs on the skin.

  • WARNINGS:

    For external use only: hands.

    Flammable. Keep away from fire or flame.

    When using this product: 

    • Keep out of eyes. • In case of contact with eyes, flush thoroughly with water. • Avoid contact with broken skin. • Do not inhale or ingest.

    • Keep out of reach of children. 

    • In case of accidental digestion, seek professional assistance or contact a Poison Control Center immediately.

  • Directions:

    Put a thumbnail size amount in your palm and rub your hands together briskly until dry. Children under 6 years of age should be supervised when using this product. Not recommended for infants.

  • Other Information:

    • Do not store above 100° F (38°C)

    • May discolor some fabrics.

    • Harmful to wood finishes & plastics.

  • Inactive Ingredients:

    ​​Water (Aqua), Glycerin, Propylene Glycol, Carbomer, Triethanolamine, Aloe Barbadensis Leaf Extract, Fragrance, Tocopheryl Acetate (Vitamin E), FD&C Red No. 2, Acid Red 18

  • QUESTIONS

    QUESTIONS OR COMMENTS?

    1-877-274-8358 Toll Free in USA

    1-909-434-0911 International

  • SPL UNCLASSIFIED SECTION

    KILLS 99% OF MOST COMMON GERMS

    barbie.com

    BARBIE and associated trademarks and trade dress are owned by, and used under license from Mattel.

    ©2020 Mattel. All Rights Reserved.   

    DESIGNED IN U.S.A.

    MADE IN CHINA

    PATENTS, COPYRIGHTS AND TRADEMARKS GRANTED OR PENDING WORLDWIDE

    DISTRIBUTED BY
    ASHTEL STUDIOS INC.
    ONTARIO, CA 91761

    SMARTCAREUS.COM

  • Packaging

    IMAGE

  • INGREDIENTS AND APPEARANCE
    BARBIE HAND SANITIZER 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72285-005
    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 HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    AMARANTH (UNII: 37RBV3X49K)  
    PONCEAU 4R (UNII: Z525CBK9PG)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72285-005-0129 mL in 1 BOTTLE; Type 0: Not a Combination Product06/16/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/16/2020
    Labeler - Yozzi Co.,ltd (560426393)
    Establishment
    NameAddressID/FEIBusiness Operations
    Yozzi Co.,ltd560426393manufacture(72285-005)
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