Label: COLABORATORY HAND SANITIZER- alcohol solution

  • 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 18, 2020

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  • Drug Facts

  • Active ingredient

    Ethyl Alcohol v/v 70%

  • Purpose

    Antiseptic

  • USE

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

    Flammable. Keep away from fire or flame.

    For external use only

    When using this product

    • Avoid contact with eyes. If contact occurs, flush eyes with water.
    • Avoid contact with broken skin.

    Stop use and consult doctor if irritation and redness develop and last.

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

  • Directions

    • Wet hands with product and allow to dry without wiping.
    • For children under 6, use only under adult supervision.
    • Not recommended for infants.
  • Other information

    • Store below 83°F (26.6°C
    • May discolor certain fabrics or surfaces
  • Inactive ingredients:

    Acrylates Copolymer, Glycerin, Hydrogen Peroxide, Sodium Hydroxide, Water

  • SPL UNCLASSIFIED SECTION

    alcohol antiseptic 70%

    topical solution

    non-sterile solution

    Doehler North America
    400 High Point Road SE
    Cartersville, GA

    for consumer complaints
    please call 770 387 0451
    select the prompt to customer service

  • Packaging

    Colabnw

  • INGREDIENTS AND APPEARANCE
    COLABORATORY HAND SANITIZER 
    alcohol solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77278-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 L  in 100 L
    Inactive Ingredients
    Ingredient NameStrength
    BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77278-001-011.83 L in 1 BOTTLE; Type 0: Not a Combination Product06/03/2020
    2NDC:77278-001-023.67 L in 1 BOTTLE; Type 0: Not a Combination Product06/03/2020
    3NDC:77278-001-0318.93 L in 1 PAIL; Type 0: Not a Combination Product06/03/2020
    4NDC:77278-001-04208.2 L in 1 DRUM; Type 0: Not a Combination Product06/03/2020
    5NDC:77278-001-05999.4 L in 1 CONTAINER; Type 0: Not a Combination Product06/03/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/03/2020
    Labeler - Doehler USA Inc. (040455356)
    Establishment
    NameAddressID/FEIBusiness Operations
    Doehler USA Inc.040455356manufacture(77278-001)
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