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 July 9, 2020

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

  • Drug Facts

  • Active Ingredient

    Ethyl Alcohol 62%

  • Purpose

    Antiseptic

  • Use

    To help reduce bacteria and germs on the skin.

  • WARNING

    Flammable. Keep away from fire or flame. For external use only • Stop use and ask a doctor if irritation or redness develops and persists.

    Keep out of reach of children. • In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

  • Directions

    • Place enough product in palm to cover hands and rub hands together briskly until dry. • Children under 6, use only under adult supervision. • Not recommended for infants.

  • Other Information

    • Do not store above 100°F (38°C). • May discolor some fabrics. • Harmful to wood finishes and plastics.

  • Inactive Ingredients

    • Deionized Water, Glycerine, Carbomer, Vitamin E, Fragrance, Aloe Barbadensis Gel, Triethanolamine, Propylene Glycol.

  • SPL UNCLASSIFIED SECTION

    KILLS UP TO 99% OF MOST COMMON GERMS

    Smart Care®

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  • Packaging

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  • INGREDIENTS AND APPEARANCE
    BARBIE HAND SANITIZER 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72922-005
    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)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72922-005-0153 mL in 1 BOTTLE; Type 0: Not a Combination Product06/29/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/29/2020
    Labeler - ShangRao chunyu Technology CO.,LTD. (541569308)
    Establishment
    NameAddressID/FEIBusiness Operations
    ShangRao chunyu Technology CO.,LTD.541569308manufacture(72922-005)