Label: LACTONE HAND SANITIZER- 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 May 28, 2020

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  • Drug Facts

  • Active ingredient

    Ethyl Alcohol 80%

  • Purpose

    Antiseptic

  • Uses Hand Sanitizer Spray to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

  • Warnings

    For external use only. Flammable, keep away from heat or flame.

    Do not use

    • in children less than 2 months of age
    • 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 Centre 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 between 15-30C (59-86F)
    • Avoid freezing and excessive heat above 40C (104F)
  • Inactive ingredients:

    Butan, Isobutan, Propan, Glycerin, Aloe Barbadensis Leaf Extract, Vitamin E

  • SPL UNCLASSIFIED SECTION

    Producer

    ALL ONE KOZMETIL SAN. VE DIS. TIC.A.S

    Sutluce Mahallesi

    Uzunbayir Sokak No:44/4

    Beyoglu/Istanbul

    FLAMMABLE

    Production date: See bottle printed code.

    Expiry date: 2 years after production date.

    MADE IN TURKEY

    KILLS COLD & FLU VIRUSES

    with ALOE VERA

    Kills 99.99% of germs without water

    EXTRA HYGIENE

  • Packaging

    IMAGE

  • INGREDIENTS AND APPEARANCE
    LACTONE HAND SANITIZER 
    ethyl alcohol spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75348-550
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL80 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    BUTANE (UNII: 6LV4FOR43R)  
    ISOBUTANE (UNII: BXR49TP611)  
    PROPANE (UNII: T75W9911L6)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75348-550-12125 mL in 1 BOTTLE; Type 0: Not a Combination Product04/22/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/22/2020
    Labeler - ALL ONE KOZMETIK SANAYI DIS TICARET ANONIM SIRKETI (519983719)
    Establishment
    NameAddressID/FEIBusiness Operations
    ALL ONE KOZMETIK SANAYI DIS TICARET ANONIM SIRKETI519983719manufacture(75348-550)
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