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 ingredients

    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 use 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 caustion in exposing skin to  sunlight after applying ths 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 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

  • questions or comments?

    Call: 1-888-287-1915

  • Guarantee

    Satisfaction guaranteed- Or we'll replace it or give you your money back.  For questions or comments or to report an undesired reaction or side effect, please call 1-888-287-1915

  • Disclaimer

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

  • Adverse Reactions

    Distributed by: Wal-Mart Stores, Inc

    Bentonville, AR 72716

    Wal-Mart Stores, Inc

    205.003/205AG

  • principal display panel

    equate

    Compare to Neutrogena T/Gel Therapeutic Shampoo Active Ingredient

    Original Strength

    Anti-Dandruff Formula

    Therapeutic

    Shampoo

    2.5% Coal Tar Topical

    Solution USP

    (0.5% Coal Tar)

    Relief for Itchy, Flaky Scalp

    • Keeps working even after hair has been rinsed
    • Controls symptoms of dandruff, psoriasis and seborheic dermatitis
    • Transparent formula
    • Paraben, Phthalate and Formaldehyde donor free

    Made in the USA WITH 90% OR MORE US MATERIALS Factory Certified

    8.5 FL OZ (251 mL)

    image description

  • INGREDIENTS AND APPEARANCE
    THERAPEUTIC 
    coal tar shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-009
    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 DIETHANOLAMIDE (UNII: 92005F972D)  
    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:49035-009-23251 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/08/2005
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H02/08/2005
    Labeler - Wal-Mart Stores, Inc (051957769)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(49035-009)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC088520668manufacture(49035-009)
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