Label: THERAPEUTIC- coal tar shampoo

  • Category: HUMAN OTC DRUG LABEL

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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  • Claims

    Healthy Accents

    Therapeutic

    Shampoo

    coal tar

    anti-dandruff shampoo

  • 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 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 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 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
  • 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

  • Disclaimer

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

  • 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.

  • principal display panel

    healthy

    accents

    therapeutic

    shampoo

    coal tar

    anti-dandruff shampoo

    2.5% coal tar topical solution usp

    (0.5% coal tar)

    compare to the active

    ingredient in Neutrogena

    Therapeutic T/Gel Shampoo

    8.5 FL OZ (251 mL)

    image description

  • INGREDIENTS AND APPEARANCE
    THERAPEUTIC 
    coal tar shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55316-205
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    COAL TAR (UNII: R533ESO2EC) (COAL TAR - UNII:R533ESO2EC) COAL TAR5 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:55316-205-231 in 1 CARTON05/08/2008
    1251 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 finalpart358H05/08/2008
    Labeler - DZA Brands, LLC (090322194)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(55316-205)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC088520668manufacture(55316-205)
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