Label: PSOCLEER ADVANCED PSORIASIS- salicylic acid cream

  • NDC Code(s): 64058-211-34
  • Packager: Concept Laboratories, 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 04/13

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active Ingredient

    Salicylic Acid 2%

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  • Purpose

    Psoriasis/Seborrheic Dermatitis Treatment

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  • Indications

    Helps eliminate the symptoms associated with Psoriasis and/or Seborrheic Dermatitits including itching, scaling, flaking, redness, irritation of the skin

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  • Warnings

    For external use only

    Avoid contact with eyes

    If eye contact occurs, rinse thoroughly with water

    If pregnant or nursing, seek the advice of a health professional before using

    When using this product use only as directed

    If condition covers a large area of the body, consult your doctor before using this product

    Stop use and ask a doctor if condition worsens or does not improve after regular use of the product as directed

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

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  • Directions

    For Adults 18 years of age and older

    Apply a small amount of cream in a downward motion to coat affected area one to four times daily or as directed by a doctor.

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  • Inactive ingredients

    Water (Aqua), Propylene Glycol, Glyceryl Stearate SE, Mineral Oil, Ceteareth-20, Glycerin, Cetearyl Alcohol, Stearic Acid, Sodium Hydroxide, DMDM Hydantoin, Methylparaben, Epilobium Angustofolium Flower/Leaf/Stem Extract, Melaleuca Alternifolia (Alfalfa) Extract, Arnica Montana Flower Extract, Propylparaben, Tocopheryl Acetate.

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  • Questions or Comments?

    Call toll free 1-888-373-8831

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  • SPL UNCLASSIFIED SECTION

    Manufactured by:
    Concept Laboratories, Inc.
    Chicago, IL 60642
    www.conceptlabs.org

    CL 9960

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  • PRINCIPAL DISPLAY PANEL - 113g Bottle Label

    SAFE AND
    EFFECTIVE

    PsoCleer
    with 2% Salicylic Acid

    ADVANCED

    Psoriasis Cream

    For Relief of Flaking, Scaling & Itching

    net weight 4oz. (113g)

    Principal Display Panel - 113g Bottle Label
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  • INGREDIENTS AND APPEARANCE
    PSOCLEER   ADVANCED PSORIASIS
    salicylic acid cream
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:64058-211
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Salicylic Acid (Salicylic Acid) Salicylic Acid 2.26 g  in 113 g
    Inactive Ingredients
    Ingredient Name Strength
    Water  
    Glycerin  
    GLYCERYL MONOSTEARATE  
    MINERAL OIL  
    STEARIC ACID  
    ARNICA MONTANA FLOWER  
    ALFALFA LEAF  
    EPILOBIUM ANGUSTIFOLIUM FLOWERING TOP  
    SODIUM HYDROXIDE  
    DMDM HYDANTOIN  
    PROPYLENE GLYCOL  
    METHYLPARABEN  
    PROPYLPARABEN  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:64058-211-34 113 g in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part358H 01/08/2010
    Labeler - Concept Laboratories, Inc. (962282612)
    Establishment
    Name Address ID/FEI Business Operations
    Concept Laboratories, Inc. 962282612 MANUFACTURE(64058-211)
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