Label: CLEAN WORKS HAND SANITIZER ANTIBACTERIAL- alcohol solution

  • 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 April 27, 2020

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

  • Active Ingredient(s)

    Ethyl Alcohol 75% v/v. Purpose: Antiseptic

  • Purpose

    Antimicrobial

  • Use

    To reduce bacteria on the skin

    Recommended for repeated use

  • Warnings

    Flammable. Keep away from fire or flame

    For external use only.

  • WHEN USING

    When using this product keep out of eyes. In case of contact with eyes, flush thoroughly with water.

    Avoid contact with broken skin

    Do not inhale or ingest

  • STOP USE

    Stop use and ask a doctor if irritation or redness occur and persist

  • 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 product and rub until dry
    • For children under 6, use only under adult supervision
  • Other information

    Do not store above 110F (43C)

    May discolor some fabrics or surfaces

  • Inactive ingredients

    Water, propylene glycol, glycerin, carbomer, aloe barbadensis leaf extract, aminomethyl propanediol, tocopheryl acetate

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    CLEAN WORKS HAND SANITIZER ANTIBACTERIAL 
    alcohol solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54699-002
    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
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    CARBOMER 934 (UNII: Z135WT9208)  
    AMINOMETHYL PROPANEDIOL (UNII: CZ7BU4QZJZ)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54699-002-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product04/27/2020
    2NDC:54699-002-0260 mL in 1 BOTTLE; Type 0: Not a Combination Product04/27/2020
    3NDC:54699-002-03100 mL in 1 BOTTLE; Type 0: Not a Combination Product04/27/2020
    4NDC:54699-002-04250 mL in 1 BOTTLE; Type 0: Not a Combination Product04/27/2020
    5NDC:54699-002-05300 mL in 1 BOTTLE; Type 0: Not a Combination Product04/27/2020
    6NDC:54699-002-06500 mL in 1 BOTTLE; Type 0: Not a Combination Product04/27/2020
    7NDC:54699-002-071000 mL in 1 BOTTLE; Type 0: Not a Combination Product04/27/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/27/2020
    Labeler - Ouya Cosmetics Co., Ltd of Yiwu (546464926)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ouya Cosmetics Co., Ltd of Yiwu546464926manufacture(54699-002)