Label: KLEEN SANITIZING WIPES- 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 December 1, 2020

If you are a consumer or patient please visit this version.

  • Active Ingredient(s)

    Alcohol 70%

  • 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. In case of 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 thoroughly with the product and allow to dry without wiping

  • Other information


    Keep pack tightly closed when not in use. Store in a cool and dry place.

  • Inactive ingredients

    Aqua, Nonionic Humectant <29.8%, Perfume 0.2%

  • DISPOSAL AND WASTE HANDLING

    Dispose the wipes and packaging in accordance to local legislation. Do not flush wipes down the toilet.

  • Package Label - Principal Display Panel

    kleen

    Sanitizing Wipes

    70% Alcohol

    Disinfecting Antibacterial Hand Wipes

    Kills 99.9% of germs and bacteria

    Quick drying - Highly effective

    Manufacturer:

    Speedy ltd.

    20 Jabotinsky st. Ofakim, Israel

    www.klir.co.il

    Contact: SPEEDY

    1253 Coney Island ave. Brooklyn, NY 11230

    crm@klir.co.il

    (917) 861-3525

    label

  • INGREDIENTS AND APPEARANCE
    KLEEN SANITIZING WIPES 
    alcohol cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81114-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81114-002-012450 g in 1 CANISTER; Type 0: Not a Combination Product11/22/2020
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A11/22/2020
    Labeler - Speedy Detergent Industries (2002) Ltd. (533579090)
    Registrant - Hardal Global Consulting LLC. (123584960)
    Establishment
    NameAddressID/FEIBusiness Operations
    Speedy Detergent Industries (2002) Ltd.533579090manufacture(81114-002)