Label: MEDICASP ANTI-DANDRUFF- 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 December 11, 2018

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Solubilized Coal Tar Extract 2.5% (Coal Tar, 0.5%

  • 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 the eyes. If contact occurs, rinse eyes thoroughly with water
    ♦
    use caution 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 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

    ♦
    wet hair thoroughly
    ♦
    apply the shampoo into the scalp and massage
    ♦
    lather and 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, cocamidopropyl betaine, laureth-4, fragrance, polysorbate 20, citric acid, sodium chloride, tetrasodium EDTA, DMDM hydantoin, caramel, red 40

  • Questions or comments?

    1 877 99 GENOM (43666)

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    Genomma Lab USA, Inc.,
    Houston, TX 77027

  • PRINCIPAL DISPLAY PANEL - 177 ml Bottle Carton

    ORIGINAL STRENGTH SHAMPOO

    SHAMPOO
    Medicasp®

    COAL TAR 0.5%

    Controls the symptoms of:
    PSORIASIS | DANDRUFF
    SEBORRHEIC DERMATITIS

    COAL TAR DANDRUFF SHAMPOO

    6FL OZ (177 ml)

    PRINCIPAL DISPLAY PANEL - 177 ml Bottle Carton
  • INGREDIENTS AND APPEARANCE
    MEDICASP   ANTI-DANDRUFF
    coal tar shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50066-054
    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 Sodium (UNII: MP1J8420LU)  
    DMDM Hydantoin (UNII: BYR0546TOW)  
    Caramel (UNII: T9D99G2B1R)  
    FD&C Red No. 40 (UNII: WZB9127XOA)  
    Product Characteristics
    ColorBROWNScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50066-054-011 in 1 CARTON09/16/2013
    1177 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H09/16/2013
    Labeler - Genomma Lab USA Inc. (832323534)
    Establishment
    NameAddressID/FEIBusiness Operations
    Garcoa, Inc.036464697MANUFACTURE(50066-054)
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