Label: PSORACARE- salicylic acid cream

  • 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 November 28, 2011

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  • ACTIVE INGREDIENT

    Salicylic Acid 2%

  • PURPOSE

    Psoriasis, Seborrheic Dermatitis

  • INDICATIONS & USAGE

    controls, fights, and helps prevent skin itching, irritation, redness, flaking and scaling associated with:

    • psoriasis
    • seborrheic dermatitis
  • WARNINGS

    For external use only.

  • DO NOT USE

    Do not use if you are allergic to sesame oil.

  • ASK DOCTOR

    Ask a doctor before use if condition covers a large area of the body.

  • WHEN USING

    When using this product

    • avoid contact with the eyes.  If contact occurs, rinse eyes thoroughly with water
    • if you currently use steroids or have used steroids in the recent past, it may take 1 to 3 months to see results
  • STOP USE

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

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast feeding, ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

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

  • DOSAGE & ADMINISTRATION


    • apply liberally to affected areas one to four times daily or as directed by a doctor
    • children under 2 years of age: consult a doctor
  • STORAGE AND HANDLING

    store in a cool and dry place

  • INACTIVE INGREDIENT

    Beeswax, Carbomer, Cetyl Alcohol, Coccinia Indica fruit extract, EDTA, Fragrance, Glyceryl Stearate, Holarrhena Antidysenterica leaf extract, Melia Azadirachta leaf extract, Propylene Glycol, Sesamum Indicum (Sesame) seed oil, Sodium Lauryl Sulfate, Sodium Methylparaben, Sodium Propylparaben, Stearic Acid, Triethanolamine, Polysorbate 60, White soft paraffin

  • PRINCIPAL DISPLAY PANEL

    Psoracare Label

  • INGREDIENTS AND APPEARANCE
    PSORACARE 
    salicylic acid cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76066-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID1.1 g  in 56.7 g
    Inactive Ingredients
    Ingredient NameStrength
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    COCCINIA GRANDIS FRUIT (UNII: VLJ6WOT3K5)  
    EDETIC ACID (UNII: 9G34HU7RV0)  
    HOLARRHENA PUBESCENS BARK (UNII: 5R6HPB294Y)  
    AZADIRACHTA INDICA LEAF (UNII: HKY915780T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SESAME OIL (UNII: QX10HYY4QV)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    METHYLPARABEN SODIUM (UNII: CR6K9C2NHK)  
    PROPYLPARABEN SODIUM (UNII: 625NNB0G9N)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76066-002-0256.7 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H01/02/2012
    Labeler - Healingsmith Institute Inc. (962842642)
    Registrant - Healingsmith Institute Inc. (962842642)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nikita Containers Private Limited862345246manufacture
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