Label: ALCOHOL ANTISEPTIC- alcohol gel

  • NDC Code(s): 24208-061-01
  • Packager: Bausch & Lomb Incorporated
  • 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 29, 2020

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  • Active ingredient[s]

    Alcohol 80% v/v

  • Purpose

    Antiseptic

  • Use[s]

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

  • Warnings

    For external use only. Flammable. Keep away from heat or flame.

    Do not use

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

    When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
    Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

  • Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    •
    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.
  • Other information

    •
    Store between 15-30°C (59-86°F)
    •
    Avoid freezing and excessive heat above 40°C (104°F)
  • Inactive ingredients

    glycerin, hydrogen peroxide, hydroxypropyl cellulose, purified water USP

  • Questions or comments?

    Call: 1-800-553-5340

    Marketed by:
    Bausch + Lomb, a division of
    Bausch Health US, LLC
    Bridgewater, NJ 08807

    Product of Canada

    Manufactured by:
    Bausch Health Companies Inc.
    Laval, Quebec H7L 4A8, Canada

    © 2020 Bausch & Lomb Incorporated or its affiliates

  • Principal Display Panel

    NDC 24208-061-01

    BAUSCH + LOMB

    Alcohol Antiseptic 80% Topical Gel
    Hand Sanitizer Non-sterile Gel

    3 oz (85 g)

    Not for Sale

    carton.jpg
  • INGREDIENTS AND APPEARANCE
    ALCOHOL ANTISEPTIC 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24208-061
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.8 mL  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
    WATER (UNII: 059QF0KO0R)  
    HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24208-061-011 in 1 CARTON04/13/2020
    185 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/13/2020
    Labeler - Bausch & Lomb Incorporated (196603781)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bausch Health Companies Inc.245141858MANUFACTURE(24208-061) , LABEL(24208-061) , PACK(24208-061)
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