Label: LEVEL 1 HEALTH HAND SANITIZER LIQUID NON-STERILE SOLUTION- alcohol hand sanitizer liquid

  • 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 13, 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.

  • Direction

    • 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 o-30 o C (59 o 86 oF)
    • Avoid freezing and excessive heat above 40 oC (104 oF)
  • Inactive ingredients

    glycerin, hydrogen peroxide, purified water USP

  • Principal Display Panel

    Level 1 Health

    Hand Sanitizer

    Liquid

    Non-Sterile Solution

    Topical Solution

    80% Alcohol Antiseptic

    XX fl oz (X mL)

    Manufactured by

    Continental Manufacturing Chemist, Inc.

    1501 Blue Sky Blvd, Huxley, IA 50124

    www.cmchemist.com

    515.795.2000

    Made in USA

    UPC Code

    49794-001-01_32 oz bottle label

  • INGREDIENTS AND APPEARANCE
    LEVEL 1 HEALTH HAND SANITIZER LIQUID NON-STERILE SOLUTION 
    alcohol hand sanitizer liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49794-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL80 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49794-002-01946 mL in 1 BOTTLE; Type 0: Not a Combination Product04/08/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E04/08/2020
    Labeler - Continental Manufacturing Chemist, Inc. (005278007)
    Establishment
    NameAddressID/FEIBusiness Operations
    Continental Manufacturing Chemist, Inc.005278007repack(49794-002) , manufacture(49794-002)
    Establishment
    NameAddressID/FEIBusiness Operations
    Continental Manufacturing Chemist081171390manufacture(49794-002) , repack(49794-002)
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