Label: THERAPEUTIC T PLUS- coal tar shampoo

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated May 30, 2013

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  • Active ingredient

    2.5% Coal Tar Topical Solution USP

    (0.5% Coal Tar)

  • Purpose

    Anti-Dandruff

  • Use

    Controls the symptoms of:

    • dandruff
    • seborrheic dermatitis
    • psoriasis
  • Warnings

    For external use only

  • Ask a doctor before ue if you have

    a condition which covers a large part of the body

  • When using this product

    • do not get into eyes.  If contact occurs, rinse eyes thoroughly with water.
    • use caution in exposing skin to sunlight after applying this product.  It may increase your tendency to sunburn for up to 24 hours after application.
    • do not use for prolonged periods without consulting a doctor
    • do not use with other forms of psoriasis therapy such as ultraviolet radiation or prescriptin dugs unless directed to do so by a doctor
  • Stop use and ask a doctor if

    condition worsens or does not improve after reqular use of this product as directed

  • Keep out of reach of children

    if swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • wet hair thoroughly
    • massage shampoo into the scalp
    • lather.  Leave on hair and scalp for several minutes.
    • rinse and repeat
    • for best results use at leat twice a week or as directed by a doctor
  • Other information

    • store away from direct sunlight
    • in rare istances, discoloration of gray, blonde, bleached or tinted hair may occur
  • Inactive ingredients

    water, sodium laureth sulfate, cocamide MIPA, laureth-4, cocamidopropyl betaine, fragrance,  sodium chloride, citric acid, tetrasodium EDTA, methylparaben, propylparaben, caramel, red 4

  • Disclaimer

    This product is not manufactured or distributed by the Neutorgena Corporation, distribut of Neutrogena Corporation, distributor of Neutrogena T/Gel Shampoo

  • Adverse Reactions

    Distributed by C.D.M.A., Inc

    43157 W Nine Mile

    Novi, MI 48376-0995

    www.gualitychoice.com

    Questions: 248-449-9300

  • Principal Display Panel

    QC

    Quality

    Choice

    Compare to NEUTROGENA

    Therapeutic T/Gel

    Shampoo

    Therapeutic

    T-Plus

    Dandruff Shampoo

    Coal Tar Dandruff shampoo

    Original Formula

    Controls Symptoms Of:

    Psoriasis

    Seborrheic Dermatitis

    Dandruff

    Fights:

    Itchy, Flaky Scalp

    16 FL OZ (1 PT) 473 mL

    image description

  • INGREDIENTS AND APPEARANCE
    THERAPEUTIC T PLUS 
    coal tar shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-687
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    COAL TAR (UNII: R533ESO2EC) (COAL TAR - UNII:R533ESO2EC) COAL TAR25 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    COCO MONOETHANOLAMIDE (UNII: C80684146D)  
    LAURETH-4 (UNII: 6HQ855798J)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    IMIDUREA (UNII: M629807ATL)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    CARAMEL (UNII: T9D99G2B1R)  
    FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63868-687-43473 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H05/30/2013
    Labeler - Chain Drug Marketing Association (011920774)
    Registrant - Vi-Jon (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon790752542manufacture(63868-687)
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