Label: DR. SHEFFIELD PSORIASIS MEDICATED MOISTURIZER- psoriasis medicated moisturizer lotion

  • NDC Code(s): 11527-478-64
  • Packager: Sheffield 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 December 23, 2019

If you are a consumer or patient please visit this version.

  • Drug Facts

  • Active Ingredient

    Salicylic Acid -2%

  • Purposes

    Psoriasis and seborrheic dermatitis

  • Uses

    Relieves and helps prevent recurrence of

    • itching
    • irration
    • redness
    • flaking and 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 eyes. if contact occurs, rinse throughly with water.

    Stop use and ask a doctor if condition worsens or does not improve after regular use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of the 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 a controlled room temperature 68°-77°F ( 20°- 25°C)

    Questions? 1-800-222-1087

  • Inactive ingredients

    Purifed Water, Caprylic/Capric Triglyceride, Mineral Oil, Cetyl Alcohol, Butylene Glycol, Stearic Acid, Sodium Citrate, Glyceral Stearate, Triethanolamine, PEG-100 Sterate, Polysorbate 60 , Phenoxyethanol, Carbomer, Zinc PCA, Panthenol, Camellia Oleifera leaf extract , Algea Extract, Artemisia Vulgaris Extract, Dipotassium Glycyrrhizate, Disodium EDTA, Rheum Palmatum Extract, Rosa Damascena Extract, Citric Acid, Methylparaben, Propylparaben, Dimethicone, Extra Virign Olea Europaea( Olive) Fruit oil

  • Principal Display Panel - Carton 1.0 oz

    Dr. Sheffield                                                      NDC 11527-478-64

    SHEAF-FIELD TM

    PSORIASIS

    Salicylic Acid 2%                    Medicated Moisturizer

    Made in the USA NET WT 1 oz. ( 28g)

    Principal Display Panel - Carton 1.0 oz

  • Principal Display Panel 1 oz. - Tube

    Dr. Sheffield's Psoriasis Medicated Moisturizer with salicylic acid is specially formulated to help relieve the symptoms associated with psoriasis. This moisturizer helps to: remove scales, eliminate itching, reduce redness and restore moisture.

    Dr. Sheffield's                                         NDC 11527-478-64

    SHEAF-FIELD TM

    PSORIASIS

    Salicylic Acid 2%                                    Medicated Moisturizer

    Made in the USA                                     NET WT. 1 oz (28g)

    Principal Display Panel 1 oz. - Tube

  • INGREDIENTS AND APPEARANCE
    DR. SHEFFIELD PSORIASIS MEDICATED MOISTURIZER 
    psoriasis medicated moisturizer lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11527-478
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID20 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CARBOMER 934 (UNII: Z135WT9208)  
    ZINC PIDOLATE (UNII: C32PQ86DH4)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)  
    ARTEMISIA VULGARIS ROOT (UNII: 32MP823R8S)  
    GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    RHEUM PALMATUM ROOT (UNII: G025DAL7CE)  
    ROSA DAMASCENA FLOWER (UNII: JWB78P295A)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11527-478-641 in 1 CARTON09/01/2013
    128 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H09/01/2013
    Labeler - Sheffield Pharmaceuticals LLC (151177797)
    Registrant - Sheffield Pharmaceuticals LLC (151177797)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sheffield Pharmaceuticals LLC151177797manufacture(11527-478)