Label: TERA-GEL- 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 January 19, 2016

If you are a consumer or patient please visit this version.

  • Active Ingredient

    Active Ingredient Purpose
    0.5% Coal Tar . . . . . . . . . . . . . . . Anti-Dandruff, Anti-Seborrheic
    Dermatitis, Anti-Psoriasis

  • Uses

    To control the symptoms of dandruff,
    seborrheic dermatitis, and psoriasis

  • Directions

    For best results, use at least twice a week or as directed by a physician.
    • Wet hair and scalp thoroughly.
    • Massage shampoo into scalp.
    • Leave lather on hair and scalp for several minutes.
    • Rinse and repeat

  • DOSAGE & ADMINISTRATION

    For best results, use at least twice a week or as directed by a physician.

  • Warnings

    FOR EXTERNAL USE ONLY
    Consult a physician before use if you have a condition that
    covers a large area of the body. Consult a physician or pharmacist
    before using if you intend to use this product with other forms of
    psoriasis therapy such as ultraviolet radiation or prescription drugs.
    When using this product:
    • Avoid contact with eyes. If contact occurs, rinse eyes
    thoroughly with water.
    • If improvement does not occur, or condition worsens after
    regular use, as directed, consult a physician.
    • Use caution when exposing skin to sunlight after using this
    product. It may increase the tendency to sunburn for up
    to 24 hours after using this product.
    • Do not use for prolonged periods without consulting a doctor.
    If condition worsens or does not improve after regular use of
    this product as directed, stop use and consult a physician.

  • STORAGE AND HANDLING

    15°-30°C (59°-86°F).

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed get prompt medical
    attention or contact a poison control center immediately.

  • ​Inactive Ingredients:

    Citric Acid, Cocamide DEA, Cocamidopropyl Betaine, Deionized Water, DMDM Hydantoin, Fragrance, Methylparaben, Polysorbates 20 & 80, Propylparaben, Sodium Chloride, Sodium Laureth Sulfate, Tetrasodium EDTA

  • PRINCIPAL DISPLAY PANEL

    PACKAGE LABEL

  • INGREDIENTS AND APPEARANCE
    TERA-GEL 
    coal tar shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54162-250
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    COAL TAR (UNII: R533ESO2EC) (COAL TAR - UNII:R533ESO2EC) COAL TAR0.57 g  in 114 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    COCO DIETHANOLAMIDE (UNII: 92005F972D)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54162-250-04114 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 finalpart358H07/31/2015
    Labeler - Geritrex LLC (112796248)