Label: DERMAREST PSORIASIS MEDICATED SCALP TREATMENT- salicylic acid gel

  • NDC Code(s): 63736-312-24
  • Packager: Insight Pharmaceuticals LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 January 10, 2020

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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 scalp:

    • itching
    • irritation
    • redness
    • flaking
    • scaling

    due to psoriasis and seborrheic dermatitis

  • Warnings

    For external use only

    Ask a doctor before use if you have

    psoriasis that 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 (1-800-222-1222) right away.

  • Directions

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

  • Other information

    Store at room temperature 15°-25°C (59°-77°F).

  • Inactive ingredients

    propylene glycol, purified water, SD alcohol 40, PPG-2 myristyl ether propionate, corn starch modified, zinc PCA, panthenol, aleurites moluccana seed oil, rheum palmatum extract, carthamus tinctorius (safflower) lower extract, camellia sinensis leaf extract, PPG-5-ceteth-20, edetate disodium, xanthan gum, triethanolamine, methylparaben, propylparaben, fragrance

  • Questions? 

    1-800-344-7239 dermarest.com

  • PRINCIPAL DISPLAY PANEL


    DERMAREST®
    Psoriasis
    SALICYLIC ACID 3%
    Psoriasis & Seborrheic Dermatitis Gel

    MAX STRENGTH MEDICATED GEL


    4 FL OZ (118 mL)

    PRINCIPAL DISPLAY PANEL - 118 ml Bottle Carton With Scalp Repair Zinc Complex DERMAREST® Psoriasis MEDICATED SCALP TREATMENT SALICYLIC ACID 3% PSORIASIS AND SEBORRHEIC DERMATITIS GEL HELPS ELIMINATE SCALP ITCH Removes and controls crusty build-up ∙ Soothes scalp irritation ∙ Restores moisture With natural extracts LEADER IN PSORIASIS ECZEMA RELIEF 4 FL OZ (118 ml)

  • INGREDIENTS AND APPEARANCE
    DERMAREST  PSORIASIS MEDICATED SCALP TREATMENT
    salicylic acid gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63736-312
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID3 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    CYCLOMETHICONE 4 (UNII: CZ227117JE)  
    DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
    PPG-2 MYRISTYL ETHER PROPIONATE (UNII: 88R97D8U8A)  
    BIS-PEG-18 METHYL ETHER DIMETHYL SILANE (UNII: OEB4R3WW9C)  
    KUKUI NUT OIL (UNII: TP11QR7B8R)  
    ZINC PIDOLATE (UNII: C32PQ86DH4)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    PHYMATOLITHON CALCAREUM (UNII: 6J1M3WA0ZK)  
    GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
    RHEUM PALMATUM ROOT (UNII: G025DAL7CE)  
    SAFFLOWER (UNII: 4VBL71TY4Y)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63736-312-2424 in 1 CASE12/20/2010
    11 in 1 CARTON
    1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart358H12/20/2010
    Labeler - Insight Pharmaceuticals LLC (055665422)
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