Label: VISIBLY CLEAN HAND SANITIZER- alcohol solution

  • NDC Code(s): 50157-100-01, 50157-100-02, 50157-100-03
  • Packager: Brands International
  • 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 8, 2020

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  • Drug Facts

    Active Ingredients

    Ethyl Alcohol 62%

  • Purpose

    Antiseptic

  • Uses

    • hand sanitizer to help reuce bacteris on the skin
  • Warnings

    Flammable. Keep away from fire or flame.

    For external use only.

  • WHEN USING

    When using this product do not use in or near the eyes. In case of eye contact, rinse eyes thoroughly with water.

  • STOP USE

    Stop use and ask a doctor if: irritation and redness develops.

  • 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.

  • Directions

    • apply palmful to hands
    • rub hands together vigorously until dry
    • supervise children in the use of this product.
  • Other information

    • Store below 110°F (43°C)
    • May discolor certain fabrics or surfaces.
  • Inactive ingredients

    Water, Isopropyl Alcohol, Glycerin, Carbomer, Aminomethyl Propanol, Fragrance, Propylene Glycol, Isopropyl Myristate, Aloe Barbadensis Leaf juice (Aloe Vera), Tocopheryl Acetate (Vitamin E)

  • SPL UNCLASSIFIED SECTION

    Manufactured by:

    Brands International Corp.
    Markham, ON, L6G 1B9 Canada
    www.brandsicorp.com

  • Package Label

    3SENI

  • PRINCIPAL DISPLAY PANEL

    2SENI

  • PRINCIPAL DISPLAY PANEL

    1SENI

  • INGREDIENTS AND APPEARANCE
    VISIBLY CLEAN HAND SANITIZER 
    alcohol solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50157-100
    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)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50157-100-01236 mL in 1 BOTTLE; Type 0: Not a Combination Product11/15/2014
    2NDC:50157-100-0259 mL in 1 BOTTLE; Type 0: Not a Combination Product11/15/2014
    3NDC:50157-100-03118 mL in 1 BOTTLE; Type 0: Not a Combination Product11/15/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E11/15/2014
    Labeler - Brands International (243748238)
    Registrant - Brands International (243748238)
    Establishment
    NameAddressID/FEIBusiness Operations
    Brands International243748238manufacture(50157-100)
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