Label: CVS PSORIASIS MEDICATED- salicylic acid shampoo

  • 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 16, 2010

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  • ACTIVE INGREDIENT



    Active ingredient                          Purpose
    Salicylic Acid (3%)..................................Psoriasis
  • PURPOSE




    Use for the relief of
    - itching - irritation - redness - flaking - scaling due to proriasis
  • 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.
  • INDICATIONS & USAGE

    Use for the relief of
    - itching - irritation - redness - flaking - scaling due to proriasis

    Directions for best results use at least twice a week or as directed by a doctor

    - thoroughly wet hair

    - Massage liberal amount of shampoo into the scalp

    - Leave lather on scalp for several minutes

    - Rinse and repeat.

  • WARNINGS

    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

    - do not get into 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

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.


  • DOSAGE & ADMINISTRATION



    Directions - for best results, use at least twice a week or as directed by a doctor.

    - Wet hair thoroughly. - Massage a liberal amount into your scalp.

    - Leave lather on scalp for several minutes - Rinse and repeat.
  • INACTIVE INGREDIENT



    Inactive Ingredients

    purified water, ammonium Laureth sulfate, cocoamidopropyl betaine, PEG-150 pentaerythrityl tetrastearate,
    coco-glucoside, glyceryl oleate, propylene glycol, zinc PCA, disodium EDTA, panthenol, rheum palmatum root
    (rubarb) extract, carthamus tu tinctorius (salflower) flower extract, aleurites moluccana (kukui nut) seed oil, camellia
    sinensis (green tea) leaf extract
  • PRINCIPAL DISPLAY PANEL


    c


  • INGREDIENTS AND APPEARANCE
    CVS PSORIASIS MEDICATED  
    salicylic acid shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-316
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID30 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)  
    GLYCERYL MONOOLEATE (UNII: 4PC054V79P)  
    ZINC PIDOLATE (UNII: C32PQ86DH4)  
    PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)  
    KUKUI NUT OIL (UNII: TP11QR7B8R)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    RHUBARB (UNII: G280W4MW6E)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    SUNFLOWER SEED (UNII: R9N3379M4Z)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59779-316-631 in 1 CARTON
    1236 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H07/16/2010
    Labeler - CVS Pharmacy (062312574)
    Registrant - Pharma Pac, LLC (140807475)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharma Pac, LLC140807475manufacture
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