FDA.reportPublic FDA data

Dr. Sheffield Hydrocortisone Anti itch

Manufacturer
Sheffield Pharmaceuticals LLC
Effective date
2023-10-30
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:58:25

Label at a glance#

ProductDr. Sheffield Hydrocortisone Anti itch
Active ingredientHydrocortisone
Label structure10 sections

Indications and uses

For temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to: eczema insect bites poison ivy poison oak poison sumac soaps detergents cosmetics jewelry seborrheic dermatitis psoriasis external feminine, genital and anal itching. Other uses of this product should be only under the advice and supervision of a doctor.

Dosage and administration

apply to affected area not more than 3 to 4 times daily. do not use. Consult a doctor. adults: when practical cleanse the affected area with mild soap and warm water and rinse thoroughly or by patting or blotting with toilet tissue or a soft cloth before application of this product. children under 12 years of age with external anal itching: consult a doctor.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Hydrocortisone 1.0%

Purpose

OTC - PURPOSE SECTION

Anti-itch

Uses

INDICATIONS & USAGE SECTION

For temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to:

  • eczema
  • insect bites
  • poison ivy
  • poison oak
  • poison sumac
  • soaps
  • detergents
  • cosmetics
  • jewelry
  • seborrheic dermatitis
  • psoriasis
  • external feminine, genital and anal itching.

Other uses of this product should be only under the advice and supervision of a doctor.

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

  • for the treatment of diaper rash, consult a doctor.
  • for external genital itching if you have a vaginal discharge, consult a doctor.

When using this product

OTC - WHEN USING SECTION

  • avoid contact with eyes
  • do not begin the use of any other hydrocortisone product unless you have consulted a doctor.
  • for external genital, feminine and anal itching do not exceed the recommended daily dosage unless directed by a doctor. In case of bleeding, stop use, consult a doctor.
  • do not put this product into the rectum by using fingers or any mechanical device or applicator.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • If condition worsens
  • symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and do not begin use of any other hydrocortisone product unless directed by a doctor.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 2 years and older

SPL UNCLASSIFIED SECTION

  • apply to affected area not more than 3 to 4 times daily.

Children under 2 years of age

SPL UNCLASSIFIED SECTION

  • do not use. Consult a doctor.

For external anal itching:

SPL UNCLASSIFIED SECTION

  • adults: when practical cleanse the affected area with mild soap and warm water and rinse thoroughly or by patting or blotting with toilet tissue or a soft cloth before application of this product.
  • children under 12 years of age with external anal itching: consult a doctor.

Other information

SPL UNCLASSIFIED SECTION

store at a controlled room temperature 20 - 25ºC (68 - 77ºF).

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aloe barbadensis leaf extract, Benzyl alcohol, Ceteareth-20, Cetearyl alcohol, Cetyl palmitate, Glycerin, Isopropyl myristate, Isostearyl neopentanoate, Methylparaben, PEG-40 stearate, Propylene glycol, Purified water

Principal Display Panel – 1oz Carton Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to the active ingredient of Cortizone●10®*

NDC 11527-052-55

Hydrocortisone MAXIMUM STRENGTH

Net Wt. 1 oz (28g) Hydrocortisone 1% Anti-itch Cream

Dr. Sheffield's

SHEAF-FIELDTM

Made in the USA

Principal Display Panel – 1oz Carton Label
Principal Display Panel – 1oz Carton Label

Principal Display Panel – 1oz Tube Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 11527-052-55

Hydrocortisone MAXIMUM STRENGTH

Net Wt. 1 oz (28g) Hydrocortisone 1% Anti-itch Cream

Dr. Sheffield's

SHEAF-FIELDTM

Made in the USA

Principal Display Panel – 1oz Tube Label
Principal Display Panel – 1oz Tube Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
106258hydrocortisone 1 % Topical CreamPSN4
106258hydrocortisone 10 MG/ML Topical CreamSCD4
106258hydrocortisone 1 % (as hydrocortisone acetate 1.2 % ) Topical CreamSY4
106258hydrocortisone 1 % Topical CreamSY4
106258hydrocortisone 1 GM per 100 GM Topical CreamSY4

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
HYDROCORTISONE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
15bd4439-874a-4934-9954-248e5455d460Product name120260310
9962b773-9f2e-22cc-0032-535e48ac417bProduct name320250724
56bb0587-1bf2-48b2-9d93-fc9f59d1eeb2Product name120250325
4d56e8eb-d741-d4a5-de3f-2bab1af75a60Product name720220608
626d7260-31b5-4412-84fd-579746adb6b3Product name120210513
8a011600-5e61-4c59-ab7b-54ab658a3b71Product name220181127
a919621a-248d-3c7a-1084-9f9ce286fdfdProduct name220181009
e7d5a174-836b-a0af-b014-cb0826c69ddcProduct name220181004
fcce390d-6460-4701-87cf-940d8800a1c3Product name220180212
bf065fa6-1e3b-e4c3-0bde-2dc842ceeea1Product name220150218
02657a3f-1489-66ea-f740-5ab9524e57d7Product name120140508
26f3d783-2cc1-4327-e77d-71804cf675a2Product name120140508
36fdc54c-bbeb-981e-8a53-4d768e283892Product name120140508
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
61e59a42-186b-9f4b-aec3-fb49a6debc31Product name120140508
705740e1-dee5-2610-c5a3-4c59cd9d62afProduct name120140508
7bdc4804-3832-c0df-e519-72b6d47c9792Product name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
abaf203f-619e-f265-559f-8c81af5cb1c2Product name120140508
acc4d8bb-0e29-e9f8-65f8-31e94184a9c0Product name120140508
b045ad64-0f28-9a02-2f9b-b34d94fb2278Product name120140508
bfd28ffb-d550-3fe9-f65b-10bcb7f971fdProduct name120140508
da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508
fe21f3fd-a378-0654-1972-db3c3b64470eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11527-052-51Dr. Sheffield Hydrocortisone Anti itch1 in 1 CARTONCREAM14
11527-052-51Dr. Sheffield Hydrocortisone Anti itch14 g in 1 TUBECREAM144
11527-052-55Dr. Sheffield Hydrocortisone Anti itch1 in 1 CARTONCREAM14
11527-052-55Dr. Sheffield Hydrocortisone Anti itch28 g in 1 TUBECREAM284

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11527-052DR. SHEFFIELD HYDROCORTISONE ANTI ITCH (HYDROCORTISONE) CREAM [SHEFFIELD PHARMACEUTICALS LLC]4Current NDC, Legacy NDC, 4 package rows20231031_71c9f2f4-2188-45eb-b55e-3856ac78070b.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
HydrocortisoneACTIVE INGREDIENTWI4X0X7BPJ2
HydrocortisoneACTIVE MOIETYWI4X0X7BPJ2
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0X2
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBH2
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1S2
CETYL PALMITATEINACTIVE INGREDIENT5ZA2S6B08X2
GLYCERININACTIVE INGREDIENTPDC6A3C0OX2
ISOPROPYL MYRISTATEINACTIVE INGREDIENT0RE8K4LNJS2
ISOSTEARYL NEOPENTANOATEINACTIVE INGREDIENT411THY156Q2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9T2
PEG-40 STEARATEINACTIVE INGREDIENTECU18C66Q72
POLYOXYL 20 CETOSTEARYL ETHERINACTIVE INGREDIENTYRC528SWUY2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V32
WATERINACTIVE INGREDIENT059QF0KO0R2

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11527-05211527-052-55, 11527-052-51

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
HydrocortisoneWI4X0X7BPJACTIB
ALOE VERA LEAFZY81Z83H0XIACT
BENZYL ALCOHOLLKG8494WBHIACT
POLYOXYL 20 CETOSTEARYL ETHERYRC528SWUYIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
CETYL PALMITATE5ZA2S6B08XIACT
GLYCERINPDC6A3C0OXIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
ISOSTEARYL NEOPENTANOATE411THY156QIACT
METHYLPARABENA2I8C7HI9TIACT
PEG-40 STEARATEECU18C66Q7IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT

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 · 24 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
POLYOXYL 20 CETOSTEARYL ETHERPOLYOXYL 20 CETOSTEARYL ETHERYRC528SWUYCREAM / TOPICAL180 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
ISOPROPYL MYRISTATEISOPROPYL MYRISTATE0RE8K4LNJSCREAM / TOPICAL65000 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CREAM / TOPICAL76000 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CREAM / TOPICAL76000 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHCREAM / TOPICAL160 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
ISOPROPYL MYRISTATEISOPROPYL MYRISTATE0RE8K4LNJSCREAM / TOPICAL65000 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TCREAM / TOPICAL3000 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TCREAM / TOPICAL3000 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCREAM / TOPICAL1720 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TCREAM / TOPICAL3000 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHCREAM / TOPICAL160 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
CETYL PALMITATECETYL PALMITATE5ZA2S6B08XCREAM / TOPICAL0.32 %w/wExact identifier — unii+route+dosage form
3 equally ranked IID candidates
ISOPROPYL MYRISTATEISOPROPYL MYRISTATE0RE8K4LNJSCREAM / TOPICAL65000 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHCREAM / TOPICAL160 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
CETOSTEARYL ALCOHOLCETOSTEARYL ALCOHOL2DMT128M1SCREAM / TOPICAL1428 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
CETYL PALMITATECETYL PALMITATE5ZA2S6B08XCREAM / TOPICAL0.32 %w/wExact identifier — unii+route+dosage form
3 equally ranked IID candidates
CETOSTEARYL ALCOHOLCETOSTEARYL ALCOHOL2DMT128M1SCREAM / TOPICAL1428 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
POLYOXYL 20 CETOSTEARYL ETHERPOLYOXYL 20 CETOSTEARYL ETHERYRC528SWUYCREAM / TOPICAL180 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
CETYL PALMITATECETYL PALMITATE5ZA2S6B08XCREAM / TOPICAL0.32 %w/wExact identifier — unii+route+dosage form
3 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCREAM / TOPICAL1720 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
CETOSTEARYL ALCOHOLCETOSTEARYL ALCOHOL2DMT128M1SCREAM / TOPICAL1428 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
POLYOXYL 20 CETOSTEARYL ETHERPOLYOXYL 20 CETOSTEARYL ETHERYRC528SWUYCREAM / TOPICAL180 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CREAM / TOPICAL76000 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCREAM / TOPICAL1720 mgExact identifier — unii+route+dosage form
3 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 Hydrocortisone Anti itchHYDROCORTISONESheffield Pharmaceuticals LLC71c9f2f4-2188-45eb-b55e-3856ac78070b2023-10-30WarningsExact identifier
ndc (package): 11527-052-51
ndc (package): 11527-052-55
ndc (product): 11527-052
ndc11 (package): 11527005255
ndc11 (package): 11527005251
spl id: 73503439-5ce2-480b-bf3f-9362a31c8e29
spl set id: 71c9f2f4-2188-45eb-b55e-3856ac78070b

Reported adverse events (FAERS/openFDA)#

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