HAND CLEANSE (TRICLOSAN) GEL [GREENBRIER INTERNATIONAL, INC.]

HAND CLEANSE (TRICLOSAN) GEL [GREENBRIER INTERNATIONAL, INC.]
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NDC 33992-3009-1
Set ID 0b6bb65c-100f-4ac3-9874-784fa18ff2a5
Category HUMAN OTC DRUG LABEL
Packager Greenbrier International, Inc.
Generic Name
Product Class
Product Number
Application Number PART333E
  • ACTIVE INGREDIENT

    Active Ingredient                                   Purpose

    Triclosan 0.15%..................................Antibacterial

  • PURPOSE

    Uses

    forthe temporary relief of minor aches and pains of muscles and joints.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

  • INDICATIONS & USAGE

    Other information

    • store at 20oC to 25oC (68o to 77oF)
  • WARNINGS

    Warnings

    For external use only. Avoid contact with eyes.

    Ask a doctor before use if you have cough associated with 

    • smoking
    • excessive phlegm
    • asthma
    • emphysema
    • persistent or chronic cough

    When using this product do not

    • heat
    • microwafe
    • add to hot water or any container where healing water may cause splattering and result in burns
    • use in eyes or directly on mucous membranes
    • take by mouth or place in nostrils
    • apply to wounds or damaged skin
    • bandage skin

    Consult a doctor and discontinue use if condition worsesn, persists for more than 1 week or tends to recur.

  • DOSAGE & ADMINISTRATION

    Directions

    • see important warnings under "When using this product"
    • adults & children 2 years of age & older: apply to the affected area not more than 3 to 4 times daily.
    • children under 2 years of age: consult a physician.
  • INACTIVE INGREDIENT

    Inactive Ingredients

    camphor, carbomer, ethyl alcohol, fd&c blue no.1, isopropyl alcohol, methylchloroisothiazolinone, methylisothiazolinone, sodium hydroxide, water.

  • PRINCIPAL DISPLAY PANEL

    label image

  • INGREDIENTS AND APPEARANCE
    HAND CLEANSE 
    triclosan gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:33992-3009
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN7.5 mg  in 500 mg
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    COCO DIETHANOLAMIDE (UNII: 92005F972D)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:33992-3009-1500 mg in 1 BOTTLE; Type 0: Not a Combination Product05/24/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E05/24/2013
    Labeler - Greenbrier International, Inc. (610322518)
    Establishment
    NameAddressID/FEIBusiness Operations
    China Ningbo Shangge Cosmetic Technology Corp.529287434manufacture(33992-3009)

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