Label: DR. SHEFFIELD PSORIASIS MEDICATED MOISTURIZER- salicylic acid lotion

  • NDC Code(s): 11527-478-64
  • Packager: Faria LLC dba Sheffield Pharmaceuticals
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 08/13

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

  • Drug Facts
  • Active Ingredient

    Salicylic Acid -2%

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  • Purposes

    Psoriasis and seborrheic dermatitis

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  • Uses

    Relieves and helps prevent recurrence of

    • itching
    • irration
    • redness
    • flaking and scaling due to psoriasis and seborrheic dermatitis
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  • 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.

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  • 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.

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  • Directions

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

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  • Other information

    store at a controlled room temperature 68°-77°F ( 20°- 25°C)

    Questions? 1-800-222-1087

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  • 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

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  • 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

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  • 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

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  • INGREDIENTS AND APPEARANCE
    DR. SHEFFIELD PSORIASIS MEDICATED MOISTURIZER 
    psoriasis medicated moisturizer lotion
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:11527-478
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 20 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    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 Code Package Description Marketing Start Date Marketing End Date
    1 NDC:11527-478-64 1 in 1 CARTON 09/01/2013
    1 28 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part358H 09/01/2013
    Labeler - Faria LLC dba Sheffield Pharmaceuticals (151177797)
    Registrant - Faria LLC dba Sheffield Pharmaceuticals (151177797)
    Establishment
    Name Address ID/FEI Business Operations
    Faria LLC dba Sheffield Pharmaceuticals 151177797 manufacture(11527-478)
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