Label: EQUATE EXTRA STRENGTH THERAPEUTIC DANDRUFF ANTI-DANDRUFF, ANTI-SEBORRHEIC DERMATITIS, ANTI-PSORIASIS- coal tar shampoo

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 4, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Solubilized Coal Tar Extract 5.00% (Coal Tar, 1.00%)

  • Purpose

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

  • Use

    controls the symptom of:

    • dandruff
    • seborrheic dermatitis
    • psoriasis
  • Warnings

    For external use only.

    Ask a doctor before using this product if condition 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.
    • do not use for prolonged periods without consulting a doctor.
    • do not use this product 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 (1-800-222-1222) right away.

  • Directions

    • for best results use at least twice a week or as directed by a doctor
    • wet hair thoroughly
    • massage shampoo into the 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, cocamidopropyl betaine, cocamide MEA, laureth-4, polysorbate 20, bis-hydroxyethyl dihydroxypropyl stearammonium chloride, PEG-120 methyl glucose dioleate, disodium edta, citric acid, phenoxyethanol, fragrance, methylchloroisothiazolinone, methylisothiazolinone, red 40, blue 1, yellow 5, yellow 6.

  • Questions or comments?

    1-888-287-1915

  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY: Walmart Inc.,
    Bentonville, AR 72716

  • PRINCIPAL DISPLAY PANEL - 177 mL Bottle Carton

    NDC 79903-284-01

    equate™

    Extra Strength

    Therapeutic
    Dandruff
    Shampoo

    5.00% Coal Tar
    Topical Solution
    (1.00% Coal Tar)

    • For relief of flaking &
      redness, associated with
      dandruff, seborrheic
      dermatitis, and psoriasis
    • Begins working fast

    6 FL OZ (177mL)

    PRINCIPAL DISPLAY PANEL - 177 mL Bottle Carton
  • INGREDIENTS AND APPEARANCE
    EQUATE EXTRA STRENGTH THERAPEUTIC DANDRUFF   ANTI-DANDRUFF, ANTI-SEBORRHEIC DERMATITIS, ANTI-PSORIASIS
    coal tar shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79903-284
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    COAL TAR (UNII: R533ESO2EC) (COAL TAR - UNII:R533ESO2EC) COAL TAR10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    Cocamidopropyl Betaine (UNII: 5OCF3O11KX)  
    COCO MONOETHANOLAMIDE (UNII: C80684146D)  
    Laureth-4 (UNII: 6HQ855798J)  
    Polysorbate 20 (UNII: 7T1F30V5YH)  
    Bis-Hydroxyethyl Dihydroxypropyl Stearammonium Chloride (UNII: 32II08O72A)  
    PEG-120 Methyl Glucose Dioleate (UNII: YM0K64F20V)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Methylchloroisothiazolinone (UNII: DEL7T5QRPN)  
    Methylisothiazolinone (UNII: 229D0E1QFA)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    Product Characteristics
    ColorBROWNScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79903-284-011 in 1 CARTON10/16/2023
    1177 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph drugM03210/16/2023
    Labeler - Walmart Inc. (051957769)
    Registrant - Garcoa, INC (036464697)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sigan America, LLC964976968MANUFACTURE(79903-284)
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