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

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WATERLESS ANTI-BACTERIAL HAND CLEANSER (ALCOHOL) LIQUID [TRI-COASTAL DESIGN COMPANY INC. ]
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NDC 49852-180-45, 49852-180-60, 49852-180-80
Set ID d183e8a2-7770-4468-9228-a5c8ea4ff9d2
Category HUMAN OTC DRUG LABEL
Packager Tri-Coastal Design Company Inc.
Generic Name
Product Class
Product Number
Application Number PART333A
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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 and mucous membranes
    • In the case of eyes or mucous membrane contact; rinse area thoroughly with water Use only as directed
  • 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 dime 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

    Water (Aqua), Carbomer, Glycerin, Propylene Glycol, Triethanolamine, Aloe Barbadensis Leaf Gel, Tocopheryl Acetate, Fragrance (Parfum), DC Red 33, FDC Blue 1

  • Package Label

    image description

  • INGREDIENTS AND APPEARANCE
    WATERLESS ANTI-BACTERIAL HAND CLEANSER 
    alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49852-180
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49852-180-4545 mL in 1 BOTTLE, PLASTIC
    2NDC:49852-180-6060 mL in 1 TUBE
    3NDC:49852-180-80237 mL in 1 BOTTLE, PUMP
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/15/2013
    Labeler - Tri-Coastal Design Company Inc. (609734900)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ningbo Pulisi Daily Chemical Products Co.,Ltd.529047265manufacture(49852-180)
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