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 49852-001-08
Set ID cdef3a60-d3f9-4a45-92a4-9935f8e5482d
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

    Active Ingredient
    Alcohol 65%

  • PURPOSE

    Purpose
    Antiseptic



  • INDICATIONS & USAGE

    Use

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


    Warnings
    • For external use only
    • Flammable, keep away from fire and flame
  • WHEN USING

    When using this product

    • Avoid the eyes and mucous membranes
    • In the case of eyes or mucous membrane contact, rinse area thoroughly with water
  • STOP USE

    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

    Keep out of reach of children If swallowed contact a doctor or Poison Control Center immediately

  • DOSAGE & ADMINISTRATION

    Directions

    • Spray on hands and rub together until dry
    • Supervise children in the use of this product
    • In the case of eye contact, rinse eyes thoroughly with water
  • SPL UNCLASSIFIED SECTION

    Other Information

    • Store below 105 F
    • May discolor some fabrics
  • INACTIVE INGREDIENT

    Inactive ingredients Propylene Glycol, PEG-40 Hydrogenated Castor Oil, Fragrance, Water

  • PRINCIPAL DISPLAY PANEL

    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:49852-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL65 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49852-001-088 mL in 1 BOTTLE, PUMP
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33301/07/2010
    Labeler - Tri-Coastal Design Company Inc. (609734900)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guangzhou St Eva Fine Chemical Co Ltd528039793manufacture
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