Label: TOPCARE THERAPEUTIC ANTI-DANDRUFF ANTI-DANDRUFF, ANTI-SEBORRHEIC DERMATITIS, ANTI-PSORIASIS- 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 September 12, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Solubilized coal tar extract 2.0% (Coal Tar, 0.5%)

  • Purpose

    Anti-dandruff, anti-seborrheic dematitis, anti-psoriasis

  • Use

    controls the symptom of:

    ⬥
    dandruff
    ⬥
    seborrheic dermatitis
    ⬥
    psoriasis
  • Warnings

    For external use only

    Ask a doctor before use if condition covers a large part of the body.

    When using this product

    ⬥
    avoid contact with the 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 this product with other forms of psoriasis therapy such as ultra violet 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

    ⬥
    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
  • 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, cocamidopropyl betaine, laureth-4, fragrance, polysorbate 20, citric acid, sodium chloride, disodium EDTA, phenoxyethanol, methylchloroisothiazolinone, methylisothiazolinone, red 40, blue 1, yellow 5, yellow 6.

  • Questions or comments?

    1-888-423-0139

  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY TOPCO ASSOCIATES LLC
    ELK GROVE VILLAGE, IL 60007

  • PRINCIPAL DISPLAY PANEL - 251 mL Bottle Label

    TopCare™
    beauty

    THERAPEUTIC
    ANTI-DANDRUFF
    SHAMPOO

    with 2% Coal Tar
    Topical Solution
    (0.5% Coal Tar)

    Compare to
    NEUTROGENA®
    T/Gel Shampoo*

    ORIGINAL STRENGTH

    Fights itching & flaking

    Controls the symptoms
    of dandruff, psoriasis &
    seborrheic dermatitis

    PARABEN &
    PHTHALATE FREE

    8.5 FL OZ (251 mL)

    05-4365

    Principal Display Panel - 251 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    TOPCARE THERAPEUTIC ANTI-DANDRUFF   ANTI-DANDRUFF, ANTI-SEBORRHEIC DERMATITIS, ANTI-PSORIASIS
    coal tar shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76162-190
    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-3 Sulfate (UNII: BPV390UAP0)  
    Coco Monoethanolamide (UNII: C80684146D)  
    Cocamidopropyl Betaine (UNII: 5OCF3O11KX)  
    Laureth-4 (UNII: 6HQ855798J)  
    Polysorbate 20 (UNII: 7T1F30V5YH)  
    Citric Acid Monohydrate (UNII: 2968PHW8QP)  
    Sodium Chloride (UNII: 451W47IQ8X)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Methylchloroisothiazolinone (UNII: DEL7T5QRPN)  
    Methylisothiazolinone (UNII: 229D0E1QFA)  
    FD&C Red No. 40 (UNII: WZB9127XOA)  
    FD&C Blue No. 1 (UNII: H3R47K3TBD)  
    FD&C Yellow No. 5 (UNII: I753WB2F1M)  
    FD&C Yellow No. 6 (UNII: H77VEI93A8)  
    Product Characteristics
    ColorBROWNScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76162-190-01251 mL in 1 BOTTLE; Type 0: Not a Combination Product08/31/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart358H08/31/2022
    Labeler - Topco Associates, LLC (006935977)
    Registrant - Garcoa, Inc. (036464697)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sigan Industries INC.255106239MANUFACTURE(76162-190)
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