Label: KLEAN 4 IN 1 HAND SANITIZER- alcohol 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 30, 2021

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  • SPL UNCLASSIFIED SECTION

  • Active Ingredient(s)

    Alcohol 80.16 % v/v. 73.68 % m/m  Purpose: Antiseptic

  • Purpose

    Topical Antiseptic

  • Use

    Hand Sanitizer for the hygienic treatment of hands by
    friction. For use when soap and water unavailable.

  • 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

    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 Center right away.

  • STOP USE

    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

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

    glycerin, hydrogen peroxide, purified water USP

  • Package Label - Principal Display Panel

    001 L (000 mL) NDC: 82122-005-01

    1000 ml - 1 liter Label

  • INGREDIENTS AND APPEARANCE
    KLEAN 4 IN 1 HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82122-005
    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
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) 0.35 g  in 100 g
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 0.8 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:82122-005-01857 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/30/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A08/30/2021
    Labeler - DepilatoCosmetics SAS (275215360)
    Registrant - DepilatoCosmetics SAS (275215360)
    Establishment
    NameAddressID/FEIBusiness Operations
    DepilatoCosmetics SAS275215360manufacture(82122-005)
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