Label: HANDERA INSTANT HAND SANITIZER- ethyl alcohol solution

  • 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 25, 2020

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  • Drug Facts

  • Active Ingredients

     Ethyl Alcohol 70% v/v

  • Purpose

    Antiseptic

  • Uses:

    Hand sanitizer to help bacteria on the skin.

    For use when soap and water are not available.

  • Warnings

    For external use only. Flammable. Keep away from fire or flame.

    Do Not use

    • 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.

  • 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 below 110F (43C)
    • May discolor fabrics or surfaces
  • Inactive ingredients

    Water, Glycerin, Carbomer, Perfume, Triethanolamine, Tocopheryl Acetate, Aloe Barbadensis Leaf Juice

  • Questions

    P: +1 703 343 67 67

    Mon -Fri 9:00 AM-5:00 PM You may also report serious side effects to this phone number.

  • SPL UNCLASSIFIED SECTION

    Moisturizing with vitamin E and Aloe

    KILLS 99% OF VIRUSES & GERMS

    Distributed by:

    Asena's Group LLC 22102 VA

    www.asenasgroup.com

    info@asenasgroup.com

    Made in TURKEY

  • Packaging

    untitled

  • INGREDIENTS AND APPEARANCE
    HANDERA INSTANT HAND SANITIZER 
    ethyl alcohol solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78089-027
    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)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78089-027-01100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/25/2020
    2NDC:78089-027-02236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/25/2020
    3NDC:78089-027-03500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/25/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/25/2020
    Labeler - Endeks Kimya Sanayi Ve Ticaret Anonim Sirketi (565678914)
    Establishment
    NameAddressID/FEIBusiness Operations
    Endeks Kimya Sanayi Ve Ticaret Anonim Sirketi565678914manufacture(78089-027)
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