Label: THERAPEUTIC- coal tar shampoo 

  • Label RSS
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 10/13

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

  • Claims

    Healthy Accents

    Therapeutic

    Shampoo

    coal tar

    anti-dandruff shampoo

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  • Active ingredients

    2.5% Coal Tar Topical Solution USP

    (0.5% Coal Tar)

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  • Purpose

    Anti-dandruff

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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 condition 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 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
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  • Stop use and ask a doctor if

    condition worsens or does not improve after regular 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

    • wet hair throoughly
    • 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 doctor
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  • other information

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

    water, sodium laureth sulfate, cocamide MIPA, laureth-4, fragrance, cocamidopropyl betaine, citric acid, sodium chloride, tetrasodium EDTA, methylparaben, propylparaben, imidazolidinyl urea, caramel, red 4

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  • Disclaimer

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

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  • Adverse Reactions

    Distributed by: DZA Brands, LLC

    Salisbury, NC 28147

    Scarborough, ME 0474

    For product questions or concerns contact us at 1-866-322-2439.  Please include UPC number and code from package.

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  • Principal Display Panel

    healthy

    accents

    therapeutic

    shampoo

    coal tar

    anti-dandruff shampoo

    2.5% coal tar topical solution usp

    (0.5% coal tar)

    controls the symptoms of:

    psoriasis, seborrheic dermatitis + dandruff

    compare to the active ingredient in Neutrogena Therapeutic T/Gel Shampoo

    8.5 FL OZ (251 mL)

    image description

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  • INGREDIENTS AND APPEARANCE
    THERAPEUTIC 
    coal tar shampoo
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:55316-205
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    COAL TAR (COAL TAR) COAL TAR 5 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    SODIUM LAURETH SULFATE  
    COCO DIETHANOLAMIDE  
    LAURETH-4  
    COCAMIDOPROPYL BETAINE  
    SODIUM CHLORIDE  
    CITRIC ACID MONOHYDRATE  
    IMIDUREA  
    EDETATE SODIUM  
    METHYLPARABEN  
    PROPYLPARABEN  
    CARAMEL  
    FD&C RED NO. 4  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:55316-205-23 1 in 1 CARTON
    1 251 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part358H 05/08/2008
    Labeler - DZA Brands, LLC (090322194)
    Registrant - Vi-Jon (790752542)
    Establishment
    Name Address ID/FEI Business Operations
    Vi-Jon 790752542 manufacture(55316-205)
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