FDA.reportPublic FDA data

members mark hydrocortisone

Manufacturer
Sam's West Inc
Effective date
2024-09-23
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:21:58

Label at a glance#

Productmembers mark hydrocortisone
Active ingredientHYDROCORTISONE
Label structure9 sections

Indications and uses

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

Dosage and administration

• for itching of skin irritation, inflammation, and rashes: • adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily • children under 2 years of age: do not use, ask a doctor • for external anal and genital itching, adults: • when practical, clean the affected area with mild soap and warm water and rinse thoroughly • gently dry by patting or blotting with toilet tissu...

Storage and handling

• store at 20°-25°C (68°-77°F)

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Hydrocortisone 1%

Purpose

OTC - PURPOSE SECTION

Anti-itch

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to:
  • eczema
  • psoriasis
  • poison ivy, oak, sumac
  • insect bites
  • detergents
  • jewelry
  • cosmetics
  • soaps
  • seborrheic dermatitis
  • temporarily relieves external anal and genital 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

  • in the genital area if you have a vaginal discharge. Ask a doctor.
  • for the treatment of diaper rash. Ask a doctor.

When using this product

OTC - WHEN USING SECTION

  • avoid contact with the eyes
  • do not use more than directed unless told to do so by a doctor
  • do not put directly into the rectum by using fingers or any mechanical device or applicator

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • condition worsens
  • rectal bleeding occurs
  • symptoms persist for more than 7 days or clear up and occur again within a few days, and do not begin use of any other hydrocortisone product unless you have asked a doctor

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • for itching of skin irritation, inflammation, and rashes:
  • adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily
  • children under 2 years of age: do not use, ask a doctor
  • for external anal and genital itching, adults:
  • when practical, clean the affected area with mild soap and warm water and rinse thoroughly
  • gently dry by patting or blotting with toilet tissue or a soft cloth before applying
  • apply to affected area not more than 3 to 4 times daily
  • children under 12 years of age: ask a doctor

Other information

STORAGE AND HANDLING SECTION

  • store at 20°-25°C (68°-77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

aloe barbadensis leaf juice, aluminum sulfate, calcium acetate, cetearyl alcohol, cetyl alcohol, cholecalciferol, dextrin, glycerin, isopropyl palmitate, light mineral oil, maltodextrin, methylparaben, propylene glycol, propylparaben, purified water, retinyl palmitate, sodium cetearyl sulfate, sodium lauryl sulfate, tocopherol, white petrolatum, white wax, zea mays (corn) oil

Questions or comments?

OTC - QUESTIONS SECTION

1-800-809-0469

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Member’s Mark™

COMPARE TO CORTIZONE•10® PLUS ACTIVE INGREDIENT

MAXIMUM STRENGTH

Hydrocortisone 1% Plus

ANTI-ITCH CREAM

Fast Itch Relief | PLUS 10 MOISTURIZERS

ULTRA MOISTURIZING ITCH RELIEF

•ECZEMA & PSORIASIS

•SKIN IRRITATIONS

•DRY, ITCHY SKIN

•INFLAMMATION & REDNESS

4 -2 OZ (56g) TUBES, TOTAL 8 OZ (224g)

hydrocortisone 1% plus
hydrocortisone 1% plus

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
334fe8d2-68fb-4331-a576-420e302ec069Product name720240320
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
0441a8f5-3835-497c-aedd-bc78cba56b2aProduct name120150317
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
60c52429-fcef-eb54-2387-43bc9e4f296bProduct 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
68196-973-16members mark hydrocortisone56 g in 1 TUBECREAM564
68196-973-34members mark hydrocortisone4 in 1 CARTONCREAM44

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68196-973MEMBERS MARK HYDROCORTISONE (HYDROCORTISONE) CREAM [SAM'S WEST INC]4Current NDC, Legacy NDC, 2 package rows20240927_218f0dcd-fa67-4935-8019-ecbbd53ed2f7.zip

Products#

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

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68196-97368196-973-16, 68196-973-34

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 23 matching rows.

Name, UNII, Kind table
NameUNIIKind
HYDROCORTISONEWI4X0X7BPJACTIB
ALOE VERA LEAFZY81Z83H0XIACT
ALUMINUM SULFATE34S289N54EIACT
CALCIUM ACETATEY882YXF34XIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
CETYL ALCOHOL936JST6JCNIACT
CHOLECALCIFEROL1C6V77QF41IACT
ICODEXTRIN2NX48Z0A9GIACT
GLYCERINPDC6A3C0OXIACT
ISOPROPYL PALMITATE8CRQ2TH63MIACT
LIGHT MINERAL OILN6K5787QVPIACT
MALTODEXTRIN7CVR7L4A2DIACT
METHYLPARABENA2I8C7HI9TIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PROPYLPARABENZ8IX2SC1OHIACT
WATER059QF0KO0RIACT
VITAMIN A PALMITATE1D1K0N0VVCIACT
SODIUM CETOSTEARYL SULFATE7ZBS06BH4BIACT
SODIUM LAURYL SULFATE368GB5141JIACT
TOCOPHEROLR0ZB2556P8IACT
PETROLATUM4T6H12BN9UIACT
WHITE WAX7G1J5DA97FIACT
CORN OIL8470G57WFMIACT

Source Document#

Source XML

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
members mark hydrocortisoneHYDROCORTISONESam's West Inc218f0dcd-fa67-4935-8019-ecbbd53ed2f72024-09-23WarningsExact identifier
ndc (package): 68196-973-16
ndc (package): 68196-973-34
ndc (product): 68196-973
ndc11 (package): 68196097334
ndc11 (package): 68196097316
spl id: 8b4869c2-1d17-4e21-ab2c-b7a46d052a47
spl set id: 218f0dcd-fa67-4935-8019-ecbbd53ed2f7

Reported adverse events (FAERS/openFDA)#

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