Label: PSOCLEER ADVANCED PSORIASIS- salicylic acid cream

  • Category: HUMAN OTC DRUG LABEL

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Drug Label Information

Updated April 25, 2013

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Salicylic Acid 2%

  • Purpose

    Psoriasis/Seborrheic Dermatitis Treatment

  • Indications

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

  • 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.

  • 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.

  • 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.

  • Questions or Comments?

    Call toll free 1-888-373-8831

  • SPL UNCLASSIFIED SECTION

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

    CL 9960

  • 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
  • INGREDIENTS AND APPEARANCE
    PSOCLEER   ADVANCED PSORIASIS
    salicylic acid cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64058-211
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ) Salicylic Acid2.26 g  in 113 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Glycerin (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    ALFALFA LEAF (UNII: HY3L927V6M)  
    EPILOBIUM ANGUSTIFOLIUM FLOWERING TOP (UNII: 08H094218D)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64058-211-34113 g in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart358H01/08/2010
    Labeler - Concept Laboratories, Inc. (962282612)
    Establishment
    NameAddressID/FEIBusiness Operations
    Concept Laboratories, Inc.962282612MANUFACTURE(64058-211)
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