Label: DERMAREST PSORIASIS MEDICATED SKIN TREATMENT- salicylic acid gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by 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 April 4, 2012

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Salicylic acid 3%

  • Purposes

    Psoriasis and seborrheic dermatitis treatment

  • Uses

    relieves and helps prevent recurrence of skin:

    • itching
    • irritation
    • redness
    • flaking
    • scaling

    due to psoriasis and seborrheic dermatitis

  • Warnings

    For external use only

    Ask a doctor before use 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.

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

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

  • Directions

    apply to affected areas one to four times daily or as directed by a doctor

  • Other information

    Keep carton for full drug facts.

  • Inactive ingredients

    Propylene glycol, water, cyclopentasiloxane, cyclotetrasiloxane, dimethicone crosspolymer, PPG-2 myristyl ether propionate, bis-PEG-18 methyl ether dimethyl silane, aleurites moluccana seed oil, zinc PCA, panthenol, camellia sinensis leaf extract, algae extract, dipotassium glycyrrhizate, rheum palmatum extract, carthamus tinctorius (safflower) flower extract, polysorbate 20, disodium EDTA, sodium chloride, triethanolamine, methylparaben, propylparaben

  • Questions?

    call 1-800-344-7239 or visit our website at www.dermarest.com

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    INSIGHT Pharmaceuticals, LLC.
    Langhorne, PA 19047-1749

  • PRINCIPAL DISPLAY PANEL - 118 ml Bottle Carton

    New Look!

    Dermarest™

    Psoriasis
    Medicated
    Treatment Gel

    With skin soothing
    zinc complex

    • Relieves itchy & irritated skin
    • Restores moisture
    • Reduces redness
    • Removes scales
    • Fragrance free

    Salicylic Acid 3%
    Psoriasis and Seborrheic
    Dermatitis Gel

    Dermatologist
    TESTED

    4 FL OZ (118 ml)

    Principal Display Panel - 118 ml Bottle Carton
  • INGREDIENTS AND APPEARANCE
    DERMAREST   PSORIASIS MEDICATED SKIN TREATMENT
    salicylic acid gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63736-301
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ) Salicylic Acid3.54 mL  in 118 mL
    Inactive Ingredients
    Ingredient NameStrength
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Water (UNII: 059QF0KO0R)  
    Cyclomethicone 5 (UNII: 0THT5PCI0R)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    Ether (UNII: 0F5N573A2Y)  
    Dimethyl Ether (UNII: AM13FS69BX)  
    Panthenol (UNII: WV9CM0O67Z)  
    Green Tea Leaf (UNII: W2ZU1RY8B0)  
    Safflower (UNII: 4VBL71TY4Y)  
    Polysorbate 20 (UNII: 7T1F30V5YH)  
    Edetate Disodium (UNII: 7FLD91C86K)  
    Sodium Chloride (UNII: 451W47IQ8X)  
    Methylparaben (UNII: A2I8C7HI9T)  
    Propylparaben (UNII: Z8IX2SC1OH)  
    Product Characteristics
    ColorWHITE (Clear) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63736-301-2424 in 1 CASE
    11 in 1 CARTON
    1118 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart358H10/20/2010
    Labeler - Insight Pharmaceuticals (176792315)
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