Label: PC-TAR- 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 July 5, 2016

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  • Active Ingredient:Coal Tar 1%

  • PURPOSE

    Purpose:

    Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasis

  • Intended Uses:

    To provide temporary relief to itchy, dry, and/or flaky scalp conditions

  • Directions:

    Shake well before using

    Wet hair and scalp thoroughly

    Massage shampoo into hair and scalp and work into a rich lather

    Leave shampoo on hair for several minutes

    Rinse and repeat

    Rinse thoroughly with water

  • Warnings:

    If condition covers a large part of the body, consult a physician before using this product
    When using this shampoo protect the treated area from direct sunlight. It may increase your tendency to sunburn for up to 24 hours after using this product.
    In rare instances hair discoloration may occur to gray, blonde, bleached, or tinted hair. 
    Do not use for prolonged periods without consulting a physician.
    If improvement does not occur, or condition worsens after regular use or as directed, consult a physician

    FOR EXTERNAL USE ONLY

  • KEEP OUT OF REACH OF CHILDREN

  • WARNINGS AND PRECAUTIONS

    In case of accidental ingestion, seek prompt medical attention or contact a Poison Control Center immediately. 
    Avoid contact with the eyes. If contact occurs, rinse thoroughly with water.  

  • Inactive Ingredients:

    Purified water, Cocamide DEA, Polysorbate 20 & 80, Cocamphocarboxy Glyceride, EDTA, Fragrance, Magnesium Aluminum Silicate, PEG-75 Lanolin, Hexeylene Glycol, Sodium Polnapthalene Sulfonate, 0.5% Parachlorometaxylenol (antimicrobial preservative)

  • For Questions, Comments, or InformationCall 1-800-736-3437 

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    PC-TAR 
    coal tar shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54162-200
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    COAL TAR (UNII: R533ESO2EC) (COAL TAR - UNII:R533ESO2EC) COAL TAR1.77441 g  in 177.441 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    COCAMIDE (UNII: 3YXD33R71G)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    EDETIC ACID (UNII: 9G34HU7RV0)  
    MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    PEG-75 LANOLIN (UNII: 09179OX7TB)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    NAPHTHALENESULFONIC ACID (MIXED ISOMERS) (UNII: VZW67VII75)  
    CHLOROXYLENOL (UNII: 0F32U78V2Q)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54162-200-06177.441 mL in 1 BOTTLE; Type 0: Not a Combination Product07/31/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H07/31/2015
    Labeler - Geritrex LLC (112796248)
    Establishment
    NameAddressID/FEIBusiness Operations
    Geritrex LLC112796248manufacture(54162-200)
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