Label: CLEAN WORKS HAND SANITIZER- alcohol liquid

  • 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 22, 2020

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  • Active Ingredient

    Ethyl Alcohol 75%

  • Purpose

    Antiseptic

  • Use

    Hand sanitizer to help reduce bacteria on the skin.

  • Warnings

    Flammable. Keep away from fire or flame.

    For external use only, do not inhale or ingest.

    Do not use

    in, or near the eyes. In case of contact with eyes, rinse thoroughly with water.

    Avoid contact with broken skin

    Stop use and ask a doctor if

    irritation or rash develop and persist for more than 72 hours.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center immediately.

  • Directions

    • Wet hands thoroughly with product and allow to dry without wiping.
    • For children under 6, use only under adult supervision.
    • Not recommended for infants.
  • Other information

    • Store below 110°F (43°C)
    • May discolor certain fabrics or surfaces
  • Inactive ingredients

    Water, Triethanolamine, Carbomer, Aloe Vera Gel, Glycerin, Propylene Glycol

  • Package label

    package label

  • INGREDIENTS AND APPEARANCE
    CLEAN WORKS HAND SANITIZER 
    alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78332-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78332-001-08237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/18/2020
    2NDC:78332-001-10300 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/18/2020
    3NDC:78332-001-84250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/18/2020
    4NDC:78332-001-0260 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/18/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E05/18/2020
    Labeler - Art and Cook Inc. (783853018)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sanrace Biotechnology Co., Ltd.543000938manufacture(78332-001)
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