WATERLESS ANTI-BACTERIAL HAND CLEANSER (ETHYL ALCOHOL) LIQUID [TRI-COASTAL DESIGN COMPANY INC. ]

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WATERLESS ANTI-BACTERIAL HAND CLEANSER (ETHYL ALCOHOL) LIQUID [TRI-COASTAL DESIGN COMPANY INC. ]
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NDC 49852-165-16
Set ID 96ec1b3a-d79c-43b0-93a1-8c4367faed41
Category HUMAN OTC DRUG LABEL
Packager Tri-Coastal Design Company Inc.
Generic Name
Product Class
Product Number
Application Number PART333
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  • Active Ingredient

    Ethyl Alcohol 62%

  • Purpose

    Antiseptic

  • Uses

    • For handwashing to decrease bacteria on the skin
    • Recommended for repeated use
  • Warnings

    • For external use only
    • Flammable, keep away from fire and flame
    • Does not contain grain alcohol; do not drink, if taken internally will produce serious gastric disturbances
  • When using this product

    • avoid the eyes an mucous membranes
    • in the case of eyes or mucous membrane contact; rinse area thoroughly with water
  • Stop use and ask a doctor if

    • condition worsens
    • redness or irritation develops
    • if condition persists for more than 3 days
  • Keep out of reach of children

    If swallowed contact a doctor or Poison Control Center immediately.

  • Directions

    • rub quarter sized amount between hands until dry
    • supervise children in the use of this product
    • in the case of eye contact, rinse eyes thoroughly with water
  • Other information

    • store below 105F
    • may discolor some fabrics
  • Inactive Ingredients

    Benzophenone-4, Carbomer, DC Red 33, FDC Red 40, Fragrance, Glycerin, Jojoba Oil, PEG-40 Hydrogenated Castor Oil, Propylene Glycol, Tocopherol, Triethanolamine, Water
  • Package Label

    Package Label
    image of package label


  • INGREDIENTS AND APPEARANCE
    WATERLESS ANTI-BACTERIAL HAND CLEANSER 
    ethyl alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49852-165
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    JOJOBA OIL (UNII: 724GKU717M)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49852-165-16473 mL in 1 BOTTLE, PUMP
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33309/01/2010
    Labeler - Tri-Coastal Design Company Inc. (609734900)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guangzhou St Eva Fine Chemical Co Ltd 528039793manufacture
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