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 March 30, 2016

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

  • claims

    CVS/pharmacy Extra Strength Therapeutic Dandruff  Shampoo controls redness, itching and flaking caused by severe scalp conditions.  Our active ingredient continues to provide effective scalp therapy even after you rinse.

    • Leaves hair shiny and manageable
    • Safe for regular use as directed
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  • Active ingredients

    5% Coal tar topical solution USP (1% Coal Tar)

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  • Purpose

    Anti-dandruff, Anti-seborrheic dermatitis, Anti-psoriasis

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  • use

    Controls the symptoms of:
    • dandruff
    • seborrheic dermatitis
    • psoriasis
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  • Warnings

    For external use only

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  • Ask a doctor before use if you have

    a condtion which covers a large part of the body

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  • 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 sue 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.
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  • Stop use and ask a doctor if

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

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  • Keep out of reach of children

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

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  • 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
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  • Other information

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

    water, sodium laureth sulfate, cocamide MIPA, cocamidopropyl betaine, polysorbate 20, laureth-4, bishydroxyethyl dihydroxypropyl stearammonium chloride, PEG-120 methyl glucose dioleate, tetrasodium EDTA, citric acid, fragrance, imidazolidinyl urea, methylparaben propylparaben, caramel, red 4

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  • Disclaimer

    This product is not manufactured or distributed by the Neutorgena Corporation, distributor of the registered trademark Neutrogena T/Gel.

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  • Disclaimer

    Distributed by: CVS Pharmacy, Inc.

    One CVS Drive, Woonsocket, RI 02895

    2016 CVS/pharmacy

    CVS.com 1-800-SHOP-CVS

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

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  • Package label

    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 scap conditins

    Controls the symptoms of dandruff, seborrheic dermatitis & psoriasis

    6 FL OZ (177 mL)

    image description

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  • INGREDIENTS AND APPEARANCE
    THERAPEUTIC 
    coal tar shampoo
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:59779-497
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    COAL TAR (UNII: R533ESO2EC) (COAL TAR - UNII:R533ESO2EC) COAL TAR 10.2 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    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 Code Package Description Marketing Start Date Marketing End Date
    1 NDC:59779-497-30 1 in 1 CARTON
    1 177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part358H 05/05/2009
    Labeler - CVS Pharmacy, Inc (062312574)
    Registrant - Vi-Jon (790752542)
    Establishment
    Name Address ID/FEI Business Operations
    Vi-Jon 790752542 manufacture(59779-497)
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