Label: LEVEL1 HEALTH HAND SANITIZER- alcohol antiseptic gel

  • 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 20, 2020

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  • Active Ingredient(s)

    Ethyl Alcohol 70% v/v

  • Purpose

    Antiseptic

  • Use

    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

    When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

  • STOP USE

    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

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

    Purified water USP, Glycerin, Aloe Barbadensis Leaf Juice, Isopropyl Myristate, Vitamine E Acetate, Carbomer, Propylene Glycol, Triethanolamine

  • Package Label - Principal Display Panel

    Image of 32 oz labelImage of 10 oz labelImage of 8.4 oz label

    LEVEL 1 HEALTH

    Hand Sanitizer

    Premium Moisturizing Gel

    Unscented

    WITH ALOE + VITAMIN E

    70% Alcohol Antiseptic

    XX FL OZ (XXX.X mL)

    MADE IN USA

    Distributed by

    Level 1 Health

    3636 S Geyer Rd. Suite 100

    St. Louis, MO 63127

    www.level1health.com | (314) 238-7348

  • INGREDIENTS AND APPEARANCE
    LEVEL1 HEALTH HAND SANITIZER 
    alcohol antiseptic gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74936-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    TROLAMINE (UNII: 9O3K93S3TK)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
    PEG-40 CASTOR OIL (UNII: 4ERD2076EF)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74936-001-32946.4 mL in 1 BOTTLE; Type 0: Not a Combination Product05/12/2020
    2NDC:74936-001-08249 mL in 1 BOTTLE; Type 0: Not a Combination Product05/12/2020
    3NDC:74936-001-10295.7 mL in 1 BOTTLE; Type 0: Not a Combination Product05/20/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E05/12/2020
    Labeler - Level 1 Health LLC (117476751)
    Registrant - Level 1 Health LLC (117476751)
    Establishment
    NameAddressID/FEIBusiness Operations
    Continental Manufacturing Chemist, Inc.005278007manufacture(74936-001) , analysis(74936-001) , pack(74936-001) , repack(74936-001) , label(74936-001) , relabel(74936-001)
    Establishment
    NameAddressID/FEIBusiness Operations
    Continental Manufacturing Chemist081171390manufacture(74936-001) , pack(74936-001) , label(74936-001) , repack(74936-001) , relabel(74936-001) , api manufacture(74936-001)
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