Label: BLUEBERRY CREAM ANTI-BACTERIAL HAND SANITIZER- alcohol 68% 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 May 20, 2016

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  • PURPOSE

    Antibacterial

    To decrease bacteria on skin

  • ACTIVE INGREDIENT

    Alcohol ....68%

  • DOSAGE AND ADMINISTRATION

    Rub a dime sized drop into hands

  • WARNINGS

    For external use only - hands.

    Keep out of eyes.

    Stop use and contact a doctor if irritation or redness develops.

    Flamable - keep away from flame or high heat.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

    If swallowed get medical help or poison control right away.

  • INDICATIONS AND USAGE

    To decrease bacteria on skin that could cause disease.

  • INACTIVE INGREDIENTS

    WATER (AQUA/EAU)
    GLYCERIN
    CARBOMER
    FRAGRANCE (PARFUM)
    SODIUM HYDROXIDE

  • PACKAGE LABEL

    label1

  • INGREDIENTS AND APPEARANCE
    BLUEBERRY CREAM ANTI-BACTERIAL HAND SANITIZER 
    alcohol 68% gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54860-030
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL68 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER 1342 (UNII: 809Y72KV36)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Colorblue (BLUE 299C) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54860-030-0229 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/20/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E05/03/2016
    Labeler - SHENZHEN LANTERN SCIENCE CO., LTD (421222423)
    Establishment
    NameAddressID/FEIBusiness Operations
    SHENZHEN LANTERN SCIENCE CO., LTD421222423manufacture(54860-030)
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