Label: LACTONE HAND SANITIZER WIPE- alcohol cloth

  • 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 18, 2020

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  • Active Ingredient(s)

    Ethyl Alcohol 80%

  • Purpose

    Antiseptic

  • Use

    Use for hand-washing to decrease bacteria on the skin, only when water is not available

  • Warnings

    Flammable, keep away from heat and flames. For external use only

  • WHEN USING

    When using this product

    do not get into eyes

    if contact occurs, rinse eyes thoroughly with water

  • STOP USE

    Stop use and ask a doctor if irritation or rash occurs.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    wet hands thorougly with product and allow to dry without wiping

  • Inactive ingredients

    water, Aloe Barbadensis Leaf Extract and propylene glycol

  • Package Label - Principal Display Panel

    Producer

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

    Sutluce Mahallesi

    Uzunbayır Sokak No:44/4

    Beyoglu/Istanbul

    Net weight: 5 gr

    MADE IN TURKEY

    Hand Sanitizer Wipe

    Kills 99.99% of E. coli, Salmonella enterica and Staphylococcus aureus (MRSA)

    with ALOE VERA FRAGRANCE

    For External Use only

    LACTONE HAND SANITIZING WIPES- alcohol cloth

    puch

    Package

  • INGREDIENTS AND APPEARANCE
    LACTONE HAND SANITIZER WIPE 
    alcohol cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75348-888
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL800 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75348-888-055 g in 1 POUCH; Type 0: Not a Combination Product05/22/2020
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/22/2020
    Labeler - ALL ONE KOZMETIK SANAYI DIS TICARET ANONIM SIRKETI (519983719)
    Registrant - HARDAL GLOBAL CONSULTING LLC. (123584960)
    Establishment
    NameAddressID/FEIBusiness Operations
    ALL ONE KOZMETIK SANAYI DIS TICARET ANONIM SIRKETI519983719manufacture(75348-888)
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