Label: THERAPEUTIC- coal tar shampoo

  • NDC Code(s): 72288-850-30
  • Packager: Amazon.com 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 May 23, 2022

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  • Active ingredient

    5% Coal tar topical solution USP (1% Coal tar)

  • Purpose

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

  • Use

    controls the symoptoms 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 occurrs, 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.

  • California Proposition 65 Warning

    This product contains chemicals know in the State of California to cause cancer.

  • Directions

    • for best results use at least twice a week or as directed by a doctor
    • wet hair thoroughly
    • massage shampoo into 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, polysorbate 20, laureth-4, bis-hydroxyethyl dihydroxypropyl stearammonium chloride, PEG-120 methyl glucose dioleate, tetrasodium EDTA, citric acid, methylchloroisothiazolinone, methylisothiazolinone, fragrance, caramel, red 4

  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY:

    Amazon. com Services LLC

    Seattle, WA 98109

    1-877-485-0385

    2018 Amazon.com, Inc. or its affiliates.  All rights reserved.

  • principal display panel

    SOLIMO

    Therapeutic

    Dandruff

    Shampoo

    5% COAL TAR

    TOPICAL SOLUTION USP

    (1% COAL TAR)

    Extra strength

    6 FL OZ (177 mL)

    image description

  • INGREDIENTS AND APPEARANCE
    THERAPEUTIC 
    coal tar shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72288-850
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    COAL TAR (UNII: R533ESO2EC) (COAL TAR - UNII:R533ESO2EC) COAL TAR1.02 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    COCO MONOISOPROPANOLAMIDE (UNII: 21X4Y0VTB1)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    LAURETH-4 (UNII: 6HQ855798J)  
    BISHYDROXYETHYL DIHYDROXYPROPYL STEARAMMONIUM CHLORIDE (UNII: 32II08O72A)  
    PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    CARAMEL (UNII: T9D99G2B1R)  
    FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72288-850-301 in 1 CARTON04/25/2018
    1177 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 finalpart358H04/25/2018
    Labeler - Amazon.com Services LLC (128990418)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(72288-850)
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