Label: EDU SAN- ethyl alcohol 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 March 8, 2021

If you are a consumer or patient please visit this version.

  • 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

    • on wood surfaces or glasses, utensils or dishes

    When using this product

    • do not get into eyes. In case of contact, rinse eyes thoroughly with water
    • avoid touching face and eyes
    • contact lenses should be immediately removed and rinsed

    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 below 86°F(30°C)

    • may discolor certain fabrics, keep away from sunlight

    • avoid freezing and excessive heat above 40⁰C (104⁰F)

    • container should not be reused in any way and should be disposed of safely

    • this container is made from 100% recycled plastic

  • Inactive ingredients

    aloe vera (Aloe barbadensis) leaf extract, aminomethyl propanol, betaine, carbomer 940, dl-alpha-tocopherol, water

  • Questions? +1-802-649-6998

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

    EST: 8:00 AM - 6:00 PM, Mon-Fri

  • SPL UNCLASSIFIED SECTION

    ETHYL ALCOHOL ANTISEPTIC HAND SANITIZING GEL

    WITH ALOE VERA EXTRACT

    INSTANT RESULT

    NO WATER / TOWELS

    MANUFACTURED FOR :
    FACETED PRODUCTS,
    21 Grand Avenue, #434,
    Swanton, VT, USA 05488

    MADE IN CHINA

    EDU - SAN # 973-781

    TOP QUALITY SANITIZING SOLUTIONS

    LICENSED TRADEMARK OF ORIENT GROUP INTERNATIONAL LIMITED OF HONG KONG

    REPRESENTED EXCLUSIVELY IN NORTH AMERICA by: FACETED PRODUCTS

  • Packaging

    IMAGE

  • INGREDIENTS AND APPEARANCE
    EDU SAN 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77829-002
    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
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    BETAINE (UNII: 3SCV180C9W)  
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    .ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77829-002-02237 mL in 1 BOTTLE; Type 0: Not a Combination Product03/08/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/08/2021
    Labeler - Quanzhou Zhezhixin Biochemical Technology Co., LTD (551828815)
    Establishment
    NameAddressID/FEIBusiness Operations
    Quanzhou Zhezhixin Biochemical Technology Co., LTD551828815manufacture(77829-002)