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 October 2, 2023

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

View All Sections
  • Active ingredient

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

  • Purpose

    Anti-dandruff

  • Use

    controls the symoptoms 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 occurrs, 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 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.

  • California Proposition 65 Warning

    This product contains chemicals know in the State of California to cause cancer.

  • Directions

    • for best results use at least twice a week or as directed by a doctor
    • wet hair thoroughly
    • masage shampoo into 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 MIPA, cocamidipropl betaine, polysorbate 20, laureth-4, bishydroxyethly dihydroxypropyl stearammonium chloride,  PEG-120 methyl glucose dioleate, tetrasodium EDTA, citric acid, fragrance, imidazolidinyl urea, methylparaben, propylparaben, caramel, red-4

  • SPL UNCLASSIFIED SECTION

    *This product is not manufactured or distributed by the Johnson & Johnson Corporation, owner of the registered trademark Neutrogena T/Gel.

    Distributed by: CVS Pharmacy, Inc.

    One CVS/pharmacy

    CVS.com 1-800-SHOP-CVS

    Made in the U.S.A. with U.S. and foreign compents.

  • PRINCIPAL DISPLAY PANEL

    CVS Health

    Compare to Neutrogena T/Gel Therapeutic Shampoo*

    EXTRA STRENGTH

    Therapeutic Dandruff Shampoo

    5% COAL TAR TOPICAL SOLUTION USP (1% COAL TAR)

    Controls redness, intense itching & flaking of severe scalp conditions

    Controls the symptoms of dandruff, sevorrheic dermatitis & psoriasis

    6 FL OZ (177 mL)

    image description

  • INGREDIENTS AND APPEARANCE
    THERAPEUTIC 
    coal tar shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-850
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    COAL TAR (UNII: R533ESO2EC) (COAL TAR - UNII:R533ESO2EC) COAL TAR1.02 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    COCO MONOISOPROPANOLAMIDE (UNII: 21X4Y0VTB1)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    LAURETH-4 (UNII: 6HQ855798J)  
    BISHYDROXYETHYL DIHYDROXYPROPYL STEARAMMONIUM CHLORIDE (UNII: 32II08O72A)  
    PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    IMIDUREA (UNII: M629807ATL)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    CARAMEL (UNII: T9D99G2B1R)  
    FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59779-850-301 in 1 CARTON03/15/2016
    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 finalpart358H03/15/2016
    Labeler - CVS Pharmacy, Inc. (062312574)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(59779-850)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC088520668manufacture(59779-850)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!