Label: ABUTOL PARIS ANTISEPTIC HAND SANITIZER- 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 June 4, 2020

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  • Drug Facts

  • Drug Facts

  • Active ingredient

    Ethyl alcohol 70%

  • 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. • Do not inhale or ingest.

    Stop and ask 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 discolor certain fabrics or surfaces

  • INACTIVE INGREDIENT

    carbomer, FD&C Red No.40, fragrance, glycerin, triethanolamine, water.

  • SPL UNCLASSIFIED SECTION

    Distributed by: Daisy Distribution LLC, Wood Ridge, NJ 07075
    Country Of Origin: Turkey

    You may also report any serious side effects to
    PO Box 328, Wood Ridge, NJ 07075-328

    Lot No: 200620
    Exp. Date: 06-2023
    NDC: 77418-103-10

    661799958837

    •No Rinsing Required
    •Does Not Dry The Skin

    ALCOHOL CONTENT 70%

  • Packaging

    IMAGE

  • INGREDIENTS AND APPEARANCE
    ABUTOL PARIS ANTISEPTIC HAND SANITIZER 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77418-103
    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)  
    FD&C Red No. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77418-103-101 in 1 CARTON06/08/2020
    180 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/08/2020
    Labeler - ATAK FARMA KOZMETIK VE KIMYA SANAYI TICARET ANONIM SIRKETI (566218248)
    Establishment
    NameAddressID/FEIBusiness Operations
    ATAK FARMA KOZMETIK VE KIMYA SANAYI TICARET ANONIM SIRKETI566218248manufacture(77418-103)
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