Label: ENLIVEN HAND SANITIZING GEL- ethyl alcohol gel

  • NDC Code(s): 74882-341-01, 74882-341-02, 74882-341-03
  • Packager: Procurement Services LLC
  • 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 22, 2020

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient[s]

    Ethyl Alcohol 70%

  • PURPOSE

    Purpose

    Antiseptic

  • INDICATIONS & USAGE

    Use[s]
    Hand sanitizer to help reduce bacteria that potentially
    can cause disease. For use when soap and water are not available.

  • WARNINGS

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

  • DO NOT USE

    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.

  • DOSAGE & ADMINISTRATION

    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 SAFETY INFORMATION

    Other information
    ■ Store between 15-30C (59-86F)
    ■ Avoid freezing and excessive heat above 40C (104F)

  • INACTIVE INGREDIENT

    Inactive ingredients  Water, carbomer, glycerin,
    triethanolamine.

  • Package Labeling -  Principal Display Panel

    HAND

    SANITIZING GEL

    Kills 99.9% of Germs

    Clinically-tested

    Hospital-trusted

    ENLIVEN

    Unscented

    33.8 OZ (1L)

    Distributed by
    Procurement Services LLC
    Nashville, TN 37215
    +1 (615) 345-2544
    www.pro-cure.io

    PRODUCT OF MEXICO

    NDC 74882-341-01

    8  60003 64605  2

    1 Liter Bottle

    Enliven

    500 mL Bottle

    Enliven500

    200mL Bottle

    Enliven200

    res

  • INGREDIENTS AND APPEARANCE
    ENLIVEN HAND SANITIZING GEL 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74882-341
    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
    WATER (UNII: 059QF0KO0R)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74882-341-011000 mL in 1 BOTTLE; Type 0: Not a Combination Product06/16/2020
    2NDC:74882-341-02500 mL in 1 BOTTLE; Type 0: Not a Combination Product06/16/2020
    3NDC:74882-341-03200 mL in 1 BOTTLE; Type 0: Not a Combination Product06/16/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/16/2020
    Labeler - Procurement Services LLC (117471256)
    Registrant - Procurement Services LLC (117471256)
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