FDA.reportPublic FDA data

Dr. Sheffield Psoriasis Medicated Moisturizer

Manufacturer
Sheffield Pharmaceuticals LLC
Effective date
2023-11-28
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:02:46

Label at a glance#

ProductDr. Sheffield Psoriasis Medicated Moisturizer
Active ingredientSALICYLIC ACID
Label structure10 sections

Indications and uses

Relieves and helps prevent recurrence of itching irration redness flaking and scaling due to psoriasis and seborrheic dermatitis

Dosage and administration

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

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Salicylic Acid -2%

Purposes

OTC - PURPOSE SECTION

Psoriasis and seborrheic dermatitis

Uses

OTC - WHEN USING SECTION

Relieves and helps prevent recurrence of

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

Warnings

WARNINGS SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

INDICATIONS & USAGE SECTION

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

Other information

DOSAGE & ADMINISTRATION SECTION

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

Questions? 1-800-222-1087

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Sheffield Pharmaceuticals NDC 11527-478-64

PSORIASIS

Salicylic Acid 2%

edicated Moisturizer

Made in the USA

NET WT 1 oz. ( 28g)

Principal Display Panel - Carton 1.0 ozPrincipal Display Panel - Carton 1.0 oz

Principal Display Panel 1 oz. - Tube

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Sheffield Pharmaceuticals NDC 11527-478-64

PSORIASIS

Salicylic Acid 2%

edicated Moisturizer

Made in the USA

NET WT 1 oz. ( 28g)

Principal Display Panel 1 oz. - TubePrincipal Display Panel 1 oz. - Tube

Principal Display Panel 1 oz. - TubePrincipal Display Panel 1 oz. - Tube

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
103568salicylic acid 2 % Topical LotionPSN3
103568salicylic acid 20 MG/ML Topical LotionSCD3
103568salicylic acid 2 % Topical LotionSY3

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11527-478-64Dr. Sheffield Psoriasis Medicated Moisturizer28 g in 1 TUBELOTION283
11527-478-64Dr. Sheffield Psoriasis Medicated Moisturizer1 in 1 CARTONLOTION13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11527-478DR. SHEFFIELD PSORIASIS MEDICATED MOISTURIZER (PSORIASIS MEDICATED MOISTURIZER) LOTION [SHEFFIELD PHARMACEUTICALS LLC]3Current NDC, Legacy NDC, 2 package rows20231129_03739345-2ed2-4157-89e7-48926721815b.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
SALICYLIC ACIDACTIVE INGREDIENTO414PZ4LPZ1
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZ1
ARTEMISIA VULGARIS ROOTINACTIVE INGREDIENT32MP823R8S1
BUTYLENE GLYCOLINACTIVE INGREDIENT3XUS85K0RA1
CAMELLIA OLEIFERA LEAFINACTIVE INGREDIENT5077EL0C601
CARBOMER 934INACTIVE INGREDIENTZ135WT92081
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCN1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QP1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1O1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86K1
GLYCERYL STEARATE CITRATEINACTIVE INGREDIENTWH8T92A0651
GLYCYRRHIZINATE DIPOTASSIUMINACTIVE INGREDIENTCA2Y0FE3FX1
MEDIUM-CHAIN TRIGLYCERIDESINACTIVE INGREDIENTC9H2L21V7U1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9T1
MINERAL OILINACTIVE INGREDIENTT5L8T28FGP1
OLIVE OILINACTIVE INGREDIENT6UYK2W1W1E1
PANTHENOLINACTIVE INGREDIENTWV9CM0O67Z1
PEG-100 STEARATEINACTIVE INGREDIENTYD01N1999R1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3T1
POLYSORBATE 60INACTIVE INGREDIENTCAL22UVI4M1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OH1
RHEUM PALMATUM ROOTINACTIVE INGREDIENTG025DAL7CE1
ROSA DAMASCENA FLOWERINACTIVE INGREDIENTJWB78P295A1
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULR1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65AP1
TROLAMINEINACTIVE INGREDIENT9O3K93S3TK1
WATERINACTIVE INGREDIENT059QF0KO0R1
ZINC PIDOLATEINACTIVE INGREDIENTC32PQ86DH41

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 29 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11527-47811527-478-64

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 27 matching rows.

Name, UNII, Kind table
NameUNIIKind
SALICYLIC ACIDO414PZ4LPZACTIB
WATER059QF0KO0RIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
MINERAL OILT5L8T28FGPIACT
CETYL ALCOHOL936JST6JCNIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
STEARIC ACID4ELV7Z65APIACT
SODIUM CITRATE1Q73Q2JULRIACT
GLYCERYL STEARATE CITRATEWH8T92A065IACT
TROLAMINE9O3K93S3TKIACT
PEG-100 STEARATEYD01N1999RIACT
POLYSORBATE 60CAL22UVI4MIACT
PHENOXYETHANOLHIE492ZZ3TIACT
CARBOMER 934Z135WT9208IACT
ZINC PIDOLATEC32PQ86DH4IACT
PANTHENOLWV9CM0O67ZIACT
CAMELLIA OLEIFERA LEAF5077EL0C60IACT
ARTEMISIA VULGARIS ROOT32MP823R8SIACT
GLYCYRRHIZINATE DIPOTASSIUMCA2Y0FE3FXIACT
EDETATE DISODIUM7FLD91C86KIACT
METHYLPARABENA2I8C7HI9TIACT
PROPYLPARABENZ8IX2SC1OHIACT
RHEUM PALMATUM ROOTG025DAL7CEIACT
ROSA DAMASCENA FLOWERJWB78P295AIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
DIMETHICONE92RU3N3Y1OIACT
OLIVE OIL6UYK2W1W1EIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 30 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
TROLAMINETROLAMINE9O3K93S3TKLOTION / TOPICAL360 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
BUTYLENE GLYCOLBUTYLENE GLYCOL3XUS85K0RASYSTEM / TOPICAL1400 mgExact identifier — unii+route
2 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPLOTION / TOPICAL1428 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
PEG-100 STEARATEPEG-100 MONOSTEARATEYD01N1999RLOTION / TOPICAL1 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
POLYSORBATE 60POLYSORBATE 60CAL22UVI4MLOTION / TOPICAL5 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KLOTION / TOPICAL22 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
POLYSORBATE 60POLYSORBATE 60CAL22UVI4MLOTION / TOPICAL5 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPLOTION / TOPICAL0.85 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7ULOTION / TOPICAL7 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
BUTYLENE GLYCOLBUTYLENE GLYCOL3XUS85K0RASYSTEM / TOPICAL1400 mgExact identifier — unii+route
2 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TLOTION / TOPICAL351 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNLOTION / TOPICAL1140 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHLOTION / TOPICAL140 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
OLIVE OILOLIVE OIL6UYK2W1W1ELOTION / TOPICAL32468 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7ULOTION / TOPICAL7 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
PEG-100 STEARATEPEG-100 MONOSTEARATEYD01N1999RLOTION / TOPICAL1 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CARBOMER 934CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)Z135WT9208LOTION / TOPICAL0.5 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
OLIVE OILOLIVE OIL6UYK2W1W1ELOTION / TOPICAL32468 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHLOTION / TOPICAL140 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKLOTION / TOPICAL360 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TLOTION / TOPICAL351 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNLOTION / TOPICAL1140 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPLOTION / TOPICAL0.85 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TLOTION / TOPICAL1 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KLOTION / TOPICAL22 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APLOTION / TOPICAL80 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TLOTION / TOPICAL1 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APLOTION / TOPICAL80 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CARBOMER 934CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)Z135WT9208LOTION / TOPICAL0.5 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPLOTION / TOPICAL1428 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dr. Sheffield Psoriasis Medicated MoisturizerPSORIASIS MEDICATED MOISTURIZERSheffield Pharmaceuticals LLC03739345-2ed2-4157-89e7-48926721815b2023-11-28WarningsExact identifier
ndc (package): 11527-478-64
ndc (product): 11527-478
ndc11 (package): 11527047864
spl id: 3080c930-e87b-4340-81ee-4a246634f56e
spl set id: 03739345-2ed2-4157-89e7-48926721815b

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.