Label: THERAPEUTIC- 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 February 6, 2023

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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

  • When using this product

    • do not get into eyes.  If contact occurs, rinse eyes thoroughly wih water.
    • use caution in exposing skin to sunlight after applying this product.  It may increase 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 prescription drugs unless directed to do so by a doctor
  • stop use and ask a doctor if

    condition worsens or does not improve after regular 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 least twice a week or as directed by a doctor
  • Other information

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

    water, sodium laureth sulfate, cocamide MEA, laureth-4, fragrance, sodium chloride, cocamidopropyl betaine, methylchloroisothiazolinone, methylisothiazolinone, citric acid, tetrasodium EDTA, caramel, red 4

  • disclaimer

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

  • Adverse Reactions

    DISTRIBUTED BY TOPCO ASSOCIATES LLC

    ELK GROVE VILLAGE, IL 60007-1015

    1-888-423-0139

    topcare@topco.com

    This product is not manufactured or distributed by Neutrogena T/Gel Shampoo

  • principal display panel

    TopCare beauty

    THERAPEUTIC

    ANTI-DANDRUFF SHAMPOO

    with 2.5% Coal Tar Topical Solution

    USP (0.5% Coal tar)

    Compare to

    NEUTROGENA

    T/Gel Shampoo

    ORIGINAL STRENGTH

    Fights itchy, flaky scalp

    Controls the symptoms of dandruff, psoriasis & seborrheic dermatitis

    8.5 FL OZ (251 mL)

    image description

  • INGREDIENTS AND APPEARANCE
    THERAPEUTIC 
    coal tar shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-205
    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 MONOISOPROPANOLAMIDE (UNII: 21X4Y0VTB1)  
    LAURETH-4 (UNII: 6HQ855798J)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    CARAMEL (UNII: T9D99G2B1R)  
    FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:36800-205-23251 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/27/2005
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H12/27/2005
    Labeler - Topco Associates LLC (006935977)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(36800-205)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC088520668manufacture(36800-205)
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