Label: THERAPEUTIC- coal tar shampoo

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 01/13

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

  • Claims

    RITE

    AID

    RENEWAL

    therapeutic

    SHAMPOO

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  • Active ingredient

    Active ingredient

    5% Coal Tar Topical Solution USP

    (1% Coal Tar)

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  • Purpose

    Purpose

    Anti-dandruff

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  • Use

    Use controld the symoptoms of:

    • dandruff
    • seborrheic dermatitis
    • psoriasis
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  • Warnings

    Warnings

    For external use only

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  • Ask a doctor

    Ask a doctor before use if you have a condition which covers a large part of the body

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  • When using this product

    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
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  • Stop use

    Stop use and ask a doctor if condition worsend or does not improve after reqular use of this product as directed.

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  • Keep out of reach of children

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

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  • Directions

    Directions

    • for best results use at least twice a week or as directed b a doctor
    • wet hair thoroughly
    • masage shampoo into scalp
    • lather. Leave on hair and scalp for several minutes
    • rinse and repeat
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  • Other information

    Other information

    • store away from direct sunlight
    • in rare instances, discoloration of gray, blonde, bleached or tinted hair may occur
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  • Inactive ingredients

    Inactive ingredients water, sodium laureth sulfate, cocamide DEA, cocamidipropl betaine, laureth-4, PEG-120 methyl glucose dioleate, polysorbate 20, fragrance, citric acid, imidazolidlhyl urea, bishydroxyethly dihydroxypropyl stearammonium chloride, tetrasodium EDTA, methylparaben, propylparaben, caramel, red-4

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  • Disclaimer

    This product is not manufactured or distributed by the Neutrogena Corporation, distributor of T/Gel Shampoo

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  • Adverse reactions

    DISTRIBUTED BY:

    RITE AID, 30 HUMTER LANE

    CAMP HILL, PA 17011

    MADE IN THE USA

    This product is not labeled for sale in the state of California

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  • Side panel claims

    RITE

    AID

    therapeutic

    shampoo

    extra strength

    Controls redness,

    Intense Itching + Flaking

    of Severe Scalp Conditions

    Controls Symptoms of:

    Dandruff, Psoriasis +

    Seborrheic Dermatitis

    Coal Tar Anti-Dandruff

    Shampoo

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  • Principal Display Panel

    Compare to the active ingredient of

    Neutogena T/Gel Therapeutic Shampoo

    RITE

    AID

    RENEWAL

    therapeutic

    SHAMPOO

    EXTRA STRENGTH

    Controls Redness,

    Intense Itching + Flaking

    of Severe Scalp Conditions

    Controls Symptoms of:

    Dandruff, Psoriasis +

    Seborrheic Dermatitis

    Coal Tar Anti-Dandruff

    Shampoo

    6 FL OZ

    (177 mL)

    image description

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  • INGREDIENTS AND APPEARANCE
    THERAPEUTIC 
    coal tar shampoo
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:11822-0497
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    COAL TAR (COAL TAR) COAL TAR 1.02 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    SODIUM LAURETH SULFATE  
    COCO DIETHANOLAMIDE  
    COCAMIDOPROPYL BETAINE  
    LAURETH-4  
    PEG-120 METHYL GLUCOSE DIOLEATE  
    POLYSORBATE 20  
    CITRIC ACID MONOHYDRATE  
    IMIDUREA  
    EDETATE SODIUM  
    METHYLPARABEN  
    PROPYLPARABEN  
    CARAMEL  
    FD&C RED NO. 4  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:11822-0497-6 1 in 1 CARTON
    1 177 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part358H 02/14/2011
    Labeler - Rite Aid (014578892)
    Registrant - Vi-Jon (790752542)
    Establishment
    Name Address ID/FEI Business Operations
    Vi-Jon 790752542 manufacture(11822-0497)
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