Label: ECOREDUCE ANTISEPTIC HAND SANITIZER- ethyl alcohol gel

  • Category: HUMAN OTC DRUG LABEL

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 August 26, 2020

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  • Drug Facts

  • Active ingredient

    Ethyl alcohol 70% v/v

  • Purpose

    Antiseptic

  • Uses

    • hand sanitizer to decrease bacteria on the skin
    • recommended for repeated use
    • for use when soap and water are not available
  • Warnings

    Flammable, keep away from fire/flame

    For external use only

    Do not use

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

    When using this product • do not get into eyes. In case of contact, rinse eyes thoroughly with water

    • avoid contact with broken skin

    Stop use and ask a doctor if

    • irritation and redness develop
    • condition persists for more than 72 hours

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

  • Directions

    • wet hands thoroughly with product and allow to dry without wiping
    • 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)
    • may cause discoloration to certain fabrics and surfaces
  • Inactive ingredients

    carbomer, glycerin, hydrogen peroxide, water

  • Questions?

    +1-800-369-5098

    You may also report serious side effects to this phone number.

    Mon-Fri 9:00 AM - 5:00 PM

  • SPL UNCLASSIFIED SECTION

    Scent Free

    Antiseptic non-Sterile Topical Solution

    Ecoreduce Scent Free Antiseptic Hand Sanitizer Gel helps to reduce bacteria on the hands

    ecoreduce.com

    Distributed by: Bioplanet, 21110 N Summitry Cir, Katy, TX 77449

    COUNTRY OF ORIGIN: MEXICO

    info@ecoreduce.com

    281-747-5798

  • Packaging

    untitled

  • INGREDIENTS AND APPEARANCE
    ECOREDUCE ANTISEPTIC HAND SANITIZER 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80119-101
    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
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80119-101-013785 mL in 1 BOTTLE; Type 0: Not a Combination Product08/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A08/01/2020
    Labeler - Bioplanet Corp. (966666815)
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