Label: ABUTOL SANITIZING WHITE LILAC- ethyl alcohol spray

  • 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 October 28, 2020

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  • Drug Facts

  • Active ingredient

    Ethyl alcohol 75%

  • 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

    • Extremely flammable aerosol, keep away from fire / flame.

    • Keep away from heat, hot surfaces, open flames and other ignition sources.

    • Pressurized container. Do not pierce or burn even after use.

    • Protect from the sunlight.

    • For external use only

    Do not use

    • on children less than 2 months of age

    • on open skin wounds

    When using this product • Avoid use on/or around eyes, ears, mouth, broken/irritated skin or large areas of body. In case of contact with eyes, rinse thoroughly with water several minutes. • do not inhale or ingest

    Stop and ask doctor if

    • irritation persist

    • or if product is swallowed

    Keep out of reach of children.

    If swallowed get medical help or contact a Poison Control Center right away.

  • Directions

    • Shake well before use.

    • Hold can upright at 6-7 inches away from surface and spray evenly.

    • Allow to air dry for 5 to 10 minutes. Repeat application a necessary

    • Supervise children under 6 years of age when using this product to avoid swallowing

  • Other information

    • store between 15-30°C (59-86°F)

    • Do not expose to temperatures exceeding 50 C/122F.

  • Inactive ingredients

    Butane, Propane, Isobutane, Glycerin, Parfum

  • SPL UNCLASSIFIED SECTION

    KILLS 99.9% OF VIRUSES BACTERIA*

    ALCOHOL CONTENT 75%

    *Effective at eliminating 99.9% of many common harmful germs and bacteria in as little as 15 seconds.

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

    Made in TURKEY

  • Packaging

    untitled

  • INGREDIENTS AND APPEARANCE
    ABUTOL SANITIZING WHITE LILAC 
    ethyl alcohol spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77418-306
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    BUTANE (UNII: 6LV4FOR43R)  
    PROPANE (UNII: T75W9911L6)  
    ISOBUTANE (UNII: BXR49TP611)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77418-306-50550 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product10/23/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A10/23/2020
    Labeler - ATAK FARMA KOZMETIK VE KIMYA SANAYI TICARET ANONIM SIRKETI (566218248)
    Establishment
    NameAddressID/FEIBusiness Operations
    ATAK FARMA KOZMETIK VE KIMYA SANAYI TICARET ANONIM SIRKETI566218248manufacture(77418-306)
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