Label: EUCUTASOL - coal tar cream

  • NDC Code(s): 63347-301-01, 63347-301-02
  • Packager: Blaine Labs Inc.
  • 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 02/13

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

  • Active Ingredient

    Active Ingredient

    Coal Tar (2%)

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  • Purpose

    Purpose 

      Psoriasis/Sebhorreic Dermatitis Treatment

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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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  • Uses

    Uses

    For the relief of symptoms associated with psoriasis and/or seborrheic dermatitis including:

    •  Itching, scaling, flaking, redness and irritation of the skin
    •    Treats eczema
    •    Helps prevent recurrence
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  • Warnings

    Warnings

    For external use only.

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  • Ask a doctor before use

    Ask a doctor before use

    If condition covers a large area of the body, around the rectum, in the genital area or the groin. Also, if needed for prolonged periods, or with other forms of psoriasis therapy such as ultra violet radiation or prescription drugs.

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  • Directions

    Directions

    Apply to affected areas as directed by a doctor.

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  • Other Inactive Ingredients

    Other

    Dimethicone, Hydrocortisone

    Inactive Ingredients

    Water, Xanthan Gum, Aloe Vera, Glycerin, Propylene Glycol, Safflower Oil, Dimethicone, C12/15 Alkyl Benzoate, Emulsifying Wax, Glycerol Stearate, Peg 100 Stearate, Cetyl Alcohol, Phenoxyethanol, Methylparaben, Ethylparaben, Butylparaben, Propylparaben, Isobutylparaben, Polyacrylamide, C13-14 Isoparaffin, Laureth-7, Hydrocortisone, Triethanolamine, Burdock Root, Tea Tree Oil, Lavender Oil, Chamomile Extract. F,D,and C Yellow # 5

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  • Product label

    EuCutaSol

    PHYSICIAN FORMULA PSORIASIS TREATMENT Rx

    NET WT. 4.0 oz. (112 gr.)

    NDC: 63347-301-01

    BlaineLabs (800) 307-8818   info@BlaineLabs.com   Santa Fe Springs, CA 90670

    Blaine EuCutaSol5 Label

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  • INGREDIENTS AND APPEARANCE
    EUCUTASOL 
    coal tar cream
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:63347-301
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    COAL TAR (COAL TAR) COAL TAR 2 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    XANTHAN GUM  
    ALOE VERA LEAF  
    GLYCERIN  
    PROPYLENE GLYCOL  
    SAFFLOWER OIL  
    DIMETHICONE  
    ALKYL (C12-15) BENZOATE  
    CETOSTEARYL ALCOHOL  
    GLYCERYL MONOSTEARATE  
    PEG-100 STEARATE  
    CETYL ALCOHOL  
    PHENOXYETHANOL  
    METHYLPARABEN  
    ETHYLPARABEN  
    BUTYLPARABEN  
    PROPYLPARABEN  
    ISOBUTYLPARABEN  
    POLYACRYLAMIDE (CROSSLINKED; 0.01-0.2 MOLE PERCENT BISACRYLAMIDE)  
    C13-14 ISOPARAFFIN  
    LAURETH-7  
    HYDROCORTISONE  
    TROLAMINE  
    ARCTIUM LAPPA ROOT  
    TEA TREE OIL  
    LAVENDER OIL  
    CHAMAEMELUM NOBILE FLOWER  
    FD&C YELLOW NO. 5  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:63347-301-01 112 g in 1 JAR
    2 NDC:63347-301-02 224 g in 1 JAR
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part358H 07/01/2012
    Labeler - Blaine Labs Inc. (017314571)
    Registrant - Blaine Labs Inc. (017314571)
    Establishment
    Name Address ID/FEI Business Operations
    Blaine Labs Inc. 017314571 manufacture(63347-301)
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