Label: B.CLEAN HAND SANITIZER- alcohol gel

  • NDC Code(s): 73978-001-01, 73978-001-02, 73978-001-03, 73978-001-04
  • Packager: Marque of Brands Americas, LLC
  • 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 March 30, 2020

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  • INDICATIONS & USAGE

    Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

  • ACTIVE INGREDIENT

    Ethyl Alcohol 60% v/v

  • Purpose

    Antiseptic

  • DOSAGE & ADMINISTRATION

    • Place enough product on hands to cover all surfaces. Rub hands together until dry
    • Supervise children under 6 years of age when using this product to avoid swallowing.

  • INACTIVE INGREDIENT

    Water (Aqua), Aloe Barbadensis Leaf Juice, Carbomer, Fragrance, Glycerin, Propylene Glycol,Tocopheryl Acetate, Squalane

  • Warning

    • Flammable, keep away from flame.
    • For External Use Only.
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • WHEN USING

    Keep out of eyes, ears, and mouth. In case of contact with eyes, rinse throughly with water.

  • DO NOT USE

    • in children less than 2 months of age
    • on open skin wounds
  • STOP USE

    a doctor if irritation or rash occurs. These may be signs of a serious condition.

  • OTHER SAFETY INFORMATION

    • Store between 15-30C (59-86F)
    • Avoid freezing and excessive heat above 40C (104F)
  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    B.CLEAN HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73978-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL60 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    WATER (UNII: 059QF0KO0R)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    SQUALANE (UNII: GW89575KF9)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73978-001-0159 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/30/2020
    2NDC:73978-001-02236 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/30/2020
    3NDC:73978-001-03473 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/30/2020
    4NDC:73978-001-04946 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/30/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/30/2020
    Labeler - Marque of Brands Americas, LLC (081170908)
    Establishment
    NameAddressID/FEIBusiness Operations
    Marque of Brands Americas, LLC081170908manufacture(73978-001)
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