Label: ANTI-DANDRUFF- coal tar shampoo

  • NDC Code(s): 49348-602-47
  • Packager: Strategic Sourcing Services LLC
  • 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 6, 2023

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  • Active Ingredient

    2.5% Coal Tar Topical Solution
    (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 thoroughly
    • massage shampoo into 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 a 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  T/Gel Shampoo

  • Adverse reaction

    Another Quality Product

    Distributed by McKesson

    One Post Street

    San Francisco, CA 94104

    Money Back guarantee

    Please visit us at www.sunmarkbrand.com

  • principal display panel

    sunmark

    COMPARE TO ACTIVE INGREDIENT OF T/GEL SHAMPOO

    NDC 49348-602-47

    coal tar

    anti-dandruff shampoo

    Therapeutic

    2.5% Coal Tar

    Topical Solution USP

    Controls the symptoms of psoriasis, seborrheic dermatitis & dandruff

    FIGHTS ITCHY, FLAKY SCALP

    8.5 FL OZ (251 mL)

    image description

  • INGREDIENTS AND APPEARANCE
    ANTI-DANDRUFF 
    coal tar shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49348-602
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    COAL TAR (UNII: R533ESO2EC) (COAL TAR - UNII:R533ESO2EC) COAL TAR25 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    COCO MONOETHANOLAMIDE (UNII: C80684146D)  
    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:49348-602-47251 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/21/2005
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H05/21/2005
    Labeler - Strategic Sourcing Services LLC (116956644)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(49348-602)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC088520668manufacture(49348-602)
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