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 25, 2022

If you are a consumer or patient please visit this version.

  • Active ingredient

    5% Coal Tar Topical Solution USP

    (1% Coal Tar)

  • Purpose

    Anti-dandruff

    Anti-seborrheic dermatitis

    Anti-psoriasis

  • Use controls the symptoms of:

    • dandruff
    • seborrheic dermatitis
    • psoriasis
  • WARNINGS

    Warnings

    For external use only

  • Ask a doctor before use

    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 prescription drugs unless directed to do so by a doctor
  • Stop use and ask a doctor

    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

    • for best results use at least twice a week or as directed by a doctor
    • wet hair thoroughly
    • massage shampoo into the scalp
    • lather. Leave on hair and scalp for several minutes.
    • rinse and repeat
  • 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, cocamidopropyl betaine, polysorbate 20, laureth-4, bis-hydroxyethyl dihydroxypropyl stearammonium chloride, PEG-120 methyl glucose dioleate, tetrasodium EDTA, citric acid, methylchloroisothiazolinone, methylisothiazolinone, fragrance, caramel, red 4

  • Questions or comments?

    Call: 1-888-287-1915

  • SPL UNCLASSIFIED SECTION

    Benefits

    Equate Therapeutic Shampoo helps to control the scalp itching and flaking caused by chronic scalp psoriasis, seborrheic dermatitis and common dandruff. The active ingredient in EquateTherapeutic Shampoo continues to work even after hair has been rinsed.

    The clear formula is formulated to be pleasant to use and gentle on hair. This uniquely formulated shampoo is gentle and safe for regular use as directed. The luxuriously rich lather has a fresh scent and will leave your hair shiny and manageable.

    This product is not manufactured or distributed byNeutrogena Corporation, Distributor of T/Gel Shampoo
    This product is not labeled for sale in the State of California

    Distributed by: Wal-Mart Stores Inc.
    Bentonville, AR 72216

  • PRINCIPAL DISPLAY PANEL

    NDC 49035-497-30

    Equate

    Compare to Neutrogena T/Gel Therapeutic Shampoo Extra Strength*

    Extra Strength Anti-Dandruff Formula Therapeutic Shampoo

    5% Coal Tar Topical Solution USP (1% Coal Tar)

    Long-Lasting Relief for Itchy, Flaky Scalp

    • Keeps working even after hair has been rinsed
    • Controls symptoms of dandruff, psoriasis and seborrheic dermatitis
    • Transparent formula
    • Gentle Fragrance

    6 FL OZ (177 mL)

    image description

  • INGREDIENTS AND APPEARANCE
    THERAPEUTIC 
    coal tar shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-497
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    COAL TAR (UNII: R533ESO2EC) (COAL TAR - UNII:R533ESO2EC) COAL TAR1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    COCO MONOETHANOLAMIDE (UNII: C80684146D)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    LAURETH-4 (UNII: 6HQ855798J)  
    BISHYDROXYETHYL DIHYDROXYPROPYL STEARAMMONIUM CHLORIDE (UNII: 32II08O72A)  
    PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    CARAMEL (UNII: T9D99G2B1R)  
    FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49035-497-301 in 1 PACKAGE08/31/2011
    1177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H08/31/2011
    Labeler - Wal-Mart (051957769)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(49035-497)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC088520668manufacture(49035-497)