Label: MG217 PSORIASIS- salicylic acid shampoo

  • NDC Code(s): 68093-7203-1
  • Packager: Wisconsin Pharmacal Company
  • 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 March 3, 2016

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  • Active Ingredient

    Salicylic Acid 3%

  • Purpose

    Psoriasis/Seborrheic Dermatitis Treatment

  • Uses

    For the relief of itching, scaling, redness, flaking and irritation associated with psoriasis and/or seborrheic dermatitis. Helps prevents symptom recurrence.

  • Keep out of reach of children

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

  • Warnings

    For external use only.

    Avoid contact with the eyes If contact occurs, rinse eyes thoroughly with water.

  • Consult a doctor

    if condition worsens or does not improve after regular use of this product as directed.

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

  • Other information

    Keep cap tightly closed when not in use. Store at room temperature.

  • Questions or comments?

    1-800-635-3696

  • Directions

    Apply to affected area 1 to 4 times daily, or as directed by a doctor.

  • Inactive ingredients

    Deionized water, Glycerin, Cetyl alcohol, Corn starch, Persea gratissima (Avocado) oil, Cetearyl alcohol, Dicetyl phosphate, Ceteth-10 phophate, Cyclosiloxane blend, PEG-40 Stearate, Butyrospermum parkii (Shea) butter, Isopropyl myristate, Lanolin oil, Mahonia Aquifolium (Oregon-grape root), Sodium PCA, Sodium hydroxide, Aloe vera, C12-15 Alkyl benzoate, Glycyrrhizic acid (Licorice extract), Phenoxyethanol, Methyl paraben, n-Butyl paraben, Ethyl paraben, Isobutyl paraben, Propyl paraben, a-Bisabolol, N,2,3-Trimethyl-2-Isopropylbutamide, Allantoin, D-Panthenol

  • PRINCIPAL DISPLAY PANEL

    CartonTube

  • INGREDIENTS AND APPEARANCE
    MG217 PSORIASIS 
    salicylic acid shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68093-7203
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID0.03 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    SHEA BUTTER (UNII: K49155WL9Y)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    PEG-40 STEARATE (UNII: ECU18C66Q7)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    GLYCYRRHIZIN (UNII: 6FO62043WK)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    .ALPHA.-BISABOLOL, (+)- (UNII: 105S6I733Z)  
    ALLANTOIN, (+)- (UNII: XDK458E1J9)  
    DEXPANTHENOL (UNII: 1O6C93RI7Z)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    METHYL DIISOPROPYL PROPIONAMIDE (UNII: 6QOP5A9489)  
    AVOCADO OIL (UNII: 6VNO72PFC1)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETETH-10 PHOSPHATE (UNII: 4E05O5N49G)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    LANOLIN OIL (UNII: OVV5IIJ58F)  
    MAHONIA AQUIFOLIUM ROOT (UNII: 746TB9VNDP)  
    SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68093-7203-11 in 1 CARTON09/01/2013
    1104 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D09/01/2013
    Labeler - Wisconsin Pharmacal Company (800873986)
    Establishment
    NameAddressID/FEIBusiness Operations
    Wisconsin Pharmacal Company800873986manufacture(68093-7203)
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