Label: KLEAN 4-IN-1 HAND SANITIZER- moisturizing hand sanitizer 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 August 29, 2021

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  • Purpose : 

    Antiseptic

    KLEAN 4-in1 Hand Sanitizer 175 ml

  • Active Ingredient :

    Alcohol 80.00 % v/v. 

  • Use : 

    Hand Sanitizer for the hygenic treatment of hands by friction. For use when soap and water are not available.

  • SPL UNCLASSIFIED SECTION

  • Warnings :

    Avoid contact with eyes. For external use only. Flammable. Keep away from heat or flame

  • 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

    For use on clean hands. For maximum biocidal activity, pump a single dose of gel (2. 5 ml) into the palm of one hand. Then rub both hands together thoroughly including all surfaces, 30 seconds until the skin is almost dry. Let absorb an instant. Do not rinse.

  • Storage :

    at room temperature (15 à 25 °C) 2 years from the date of manufacture. Rinse package thoroughly with water before disposal.

  • Inactive ingredients :

    Purified Water - Propylene Glycol - Acrylates / C10-30 Alkyl Acrylate Crosspolymer - Methyl Gluceth-20 - PEG-90 Diisostearate

  • Package Label - Principal Display Panel

    0.175 L (175 mL) NDC: 82122-001-01image description

  • INGREDIENTS AND APPEARANCE
    KLEAN 4-IN-1 HAND SANITIZER 
    moisturizing hand sanitizer gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82122-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL73.68 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 0.8 g  in 100 g
    CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO) 0.35 g  in 100 g
    WATER (UNII: 059QF0KO0R) 24.68 g  in 100 g
    METHYL GLUCETH-20 (UNII: J3QD0LD11P) 0.13 g  in 100 g
    PEG-90 DIISOSTEARATE (UNII: YAE61SLW68) 0.25 g  in 100 g
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q) 0.11 g  in 100 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82122-001-01175 g in 1 TUBE; Type 0: Not a Combination Product10/15/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A10/15/2021
    Labeler - DepilatoCosmetics SAS (275215360)
    Registrant - DepilatoCosmetics SAS (275215360)
    Establishment
    NameAddressID/FEIBusiness Operations
    DepilatoCosmetics SAS275215360manufacture(82122-001)
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