Label: PSORIAPALM NON-GREASY PSORIASIS- salicylic acid lotion

  • 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 July 4, 2012

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  • PSORIAPALM Non-Greasy Psoriasis Lotion

    Drug Facts

  • Active ingredient

    Salicylic Acid 2%

  • Purpose

    Psoriasis and Seborrheic Dermatitis

  • 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 the 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 immediately.

  • Directions

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

  • Other Information

    Store at room temperature 15° - 30°C (59° - 86°F). Keep out of direct sunlight.

  • Inactive ingredients

    WATER, BUTYLENE GLYCOL, CETYL ALCOHOL, ISOPROPYL MYRISTATE, POLYSORBATE 60, STEARIC ACID, DIMETHICONE, GLYCERYL STEARATE, OCTYLDODECANOL, MYRISTOYL/PALMITOYL OXOSTEARAMIDE/ARACHAMIDE
    MEA, PANTHENOL, TOCOPHERYL ACETATE, CHOLESTEROL, XANTHAN GUM, METHYLBENZYL METHYLBENZIMIDAZOLE PIPERIDINYLMETHANONE, POLYACRYLAMIDE, C13-14 ISOPARAFFIN, LAURETH-7, SODIUM HYDROXIDE,
    METHYLPARABEN, PROPYLPARABEN
  • Questions?

    Visit our website at www.psoriapalm.com
  • SPL UNCLASSIFIED SECTION

    Distributed by:
    Neopharm USA, 1 Oyster Bay Drive, Rumson, NJ 07760

    Made in Korea

  • PSORIAPALM Non-Greasy Psoriasis Lotion 4oz (51141-8000-4)

    Psoriapalm

    PsoriapalmInnerPackage

  • INGREDIENTS AND APPEARANCE
    PSORIAPALM NON-GREASY PSORIASIS 
    salicylic acid lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51141-8000
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID2 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Cetyl Alcohol (UNII: 936JST6JCN)  
    Butylene Glycol (UNII: 3XUS85K0RA)  
    Stearic Acid (UNII: 4ELV7Z65AP)  
    Polysorbate 60 (UNII: CAL22UVI4M)  
    Glyceryl Monostearate (UNII: 230OU9XXE4)  
    Panthenol (UNII: WV9CM0O67Z)  
    Methylparaben (UNII: A2I8C7HI9T)  
    Propylparaben (UNII: Z8IX2SC1OH)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    MYRISTOYL/PALMITOYL OXOSTEARAMIDE/ARACHAMIDE MEA (UNII: 1211AIM8G7)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    CHOLESTEROL (UNII: 97C5T2UQ7J)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    METHYLBENZYL METHYLBENZIMIDAZOLE PIPERIDINYLMETHANONE (UNII: Z9T72Z578T)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    LAURETH-7 (UNII: Z95S6G8201)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51141-8000-41 in 1 CARTON
    1120 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart358H07/04/2012
    Labeler - Neopharm Co., Ltd (965502912)
    Establishment
    NameAddressID/FEIBusiness Operations
    Neopharm Co., Ltd631101883manufacture
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