Label: NEUTROGENA T/GEL THERAPEUTIC ORIGINAL FORMULA- coal tar shampoo

  • NDC Code(s): 69968-0763-1, 69968-0763-4, 69968-0763-8
  • Packager: Johnson & Johnson Consumer Inc.
  • 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 March 23, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Coal Tar 0.5%

    (2% Neutar ® Solubilized Coal Tar Extract)

  • Purposes

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

  • Use

    Controls the symptoms of dandruff, seborrheic dermatitis and psoriasis.

  • Warnings

    For external use only.

    Do not use

    • for prolonged periods without consulting a doctor.
    • this product with other forms of psoriasis therapy such as ultraviolet radiation or prescription drugs unless directed to do so by a doctor.

    Ask a doctor before use if you have a condition that covers a large area 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.

    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 your scalp.
    • Lather, leaving on your hair and scalp for a few minutes.
    • Rinse and repeat.
  • Other information

    • In rare instances, temporary discoloration of gray, blonde, bleached, or tinted hair may occur.
    • Store away from direct sunlight.
    • Protect from excessive heat and freezing.
  • Inactive ingredients

    Water, Sodium Laureth Sulfate, Cocamide MEA, Laureth-4, Fragrance, Sodium Dehydroacetate, Caprylyl Glycol, Sodium Chloride, Polysorbate 20, Citric Acid, Cocamidopropyl Betaine, Tetrasodium , Tetrasodium EDTA, Sodium Hydroxide

  • Questions?

    Call toll-free 877-256-4247 or 215-273-8755 (collect). www.tgel.com

  • SPL UNCLASSIFIED SECTION

    Distributed by:

    JOHNSON & JOHNSON CONSUMER INC.

    Skillman, NJ 08558

  • PRINCIPAL DISPLAY PANEL - 473 mL Bottle Carton

    NEUTROGENA®

    T/GEL®

    therapeutic

    shampoo

    ORIGINAL FORMULA

    clinically proven

    long-lasting

    relief of itching

    and flaking

    psoriasis, seborrheic

    dermatitis, dandruff

    starts working after

    just one use

    pH balanced formula

    DERMATOLOGIST

    RECOMMENDED BRAND

    Neutrogena®

    2% PURIFIED NEUTAR®

    (COAL TAR 0.5%)

    16 FL. OZ. (473 mL)

    Neutrogena_001

  • INGREDIENTS AND APPEARANCE
    NEUTROGENA T/GEL THERAPEUTIC ORIGINAL FORMULA 
    coal tar shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69968-0763
    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
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    COCO MONOETHANOLAMIDE (UNII: C80684146D)  
    LAURETH-4 (UNII: 6HQ855798J)  
    SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69968-0763-41 in 1 CARTON08/01/202201/24/2024
    1130 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:69968-0763-81 in 1 CARTON08/01/202210/09/2024
    2250 mL in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:69968-0763-11 in 1 CARTON08/01/202207/28/2024
    3473 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H08/01/202210/09/2024
    Labeler - Johnson & Johnson Consumer Inc. (118772437)
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