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

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WATERLESS ANTI BACTERIAL HAND SANITIZER (ETHYL ALCOHOL) LIQUID [TRI-COASTAL DESIGN COMPANY INC. ]
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NDC 49852-031-03
Set ID cc41ed45-8f08-4b75-8edb-9a6df9b518b3
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 63%

  • 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

  • Other information

    • Store below 105F
    • May discolor some fabrics
  • Inactive Ingredients

    Acrylates/C10-30 Alkyl Acrylate Crosspolymer, FDC Blue 1, FDC Yellow 5, Fragrance, Propylene Glycol, Triethanolamine, Water
  • Package Label

    Package Label
    image of package label

  • INGREDIENTS AND APPEARANCE
    WATERLESS ANTI BACTERIAL HAND SANITIZER 
    ethyl alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49852-031
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL63 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49852-031-03100 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33308/01/2010
    Labeler - Tri-Coastal Design Company Inc. (609734900)
    Establishment
    NameAddressID/FEIBusiness Operations
    Landy International545291775manufacture
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