HYDROCORTISONE CREAM USP, 1%

Manufacturer
Encube Ethicals, Inc. | Encube Ethicals Private Limited
Effective date
2025-11-10
Label type
Human OTC Drug Label
Version
2
Source
full-release
Hydrated at
2026-06-01 01:43:10

Label at a glance#

ProductHYDROCORTISONE
Active ingredientHYDROCORTISONE
Label structure13 sections

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: consult a doctor ■ for external anal and genital itching   ■ adults: when practical, clean the affected area with mild soap and warm water; rinse thoroughly   ■ gently dry by paling or blotting with toilet Issue or a ...

Storage and handling

■ store at 15°C to 30°C (59°F to 86°F). Protect from freezing. ■ before using any medication, read all label directions. Keep carton, it contains important information.

Label contents#

Full prescribing information#

ACTIVE INGREDIENT(S)

OTC - ACTIVE INGREDIENT SECTION

Hydrocortisone, USP 1%

PURPOSE

OTC - PURPOSE SECTION

Anti-itch

USE(S)

INDICATIONS & USAGE SECTION

■temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to 

     ■eczema ■ psoriasis ■ insect bites ■ poison ivy, oak, sumac

     ■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. Consult a doctor.
■ for the treatment o1 diaper rash. Consult a doctor.

WHEN USING THIS PRODUCT

OTC - WHEN USING SECTION

■ avoid contact with the eyes

■ do not use more than directed unless directed by a doctor

■ do not put directly into the rectum by using fingers or any mechanical device or  isopropyl applicator

STOP USE AND ASK DOCTOR IF

OTC - STOP USE SECTION

■ condition worsens, symptoms persist for more than 7 days or clear up and occur again within a few days

■ do not begin the use of any other hydrocortisone product unless directed by a doctor

■ rectal bleeding occurs

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 (1-800-222-1222) 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: consult a doctor

■ for external anal and genital itching

  ■ adults: when practical, clean the affected area with mild soap and warm water; rinse thoroughly

  ■ gently dry by paling or blotting with toilet Issue or a soft cloth before application of this product

  ■ apply to affected area not more than 3 to 4 times daily 

  ■ children under 12 years of age: consult a doctor

OTHER INFORMATION

STORAGE AND HANDLING SECTION

■ store at 15°C to 30°C (59°F to 86°F). Protect from freezing.

■ before using any medication, read all label directions. Keep carton, it contains important information.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

cetyl alcohol, citric acid*, glyceryl stearate, isopropyl myristate, methylparaben, polyoxyl 40 stearate, polysorbate 60, propylene glycol, propylparaben, purified water, sodium citrate solution* sorbic acid, sorbitan monostearate, stearyl alcohol, white wax

*Contains one or more of these ingredients to adjust pH

QUESTIONS OR COMMENTS?

SPL UNCLASSIFIED SECTION

Call 1-833-285-4151

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Hydrocortisone Cream USP, 1%

Anti-itch Cream

Net wt. 1 oz (28g)

carton28g
carton28g

Hydrocortisone Cream USP, 1%

Anti-itch Cream

Net wt. 0.5 oz (14g)

carton14gcarton14g

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
106258hydrocortisone 1 % Topical CreamPSN2
106258hydrocortisone 10 MG/ML Topical CreamSCD2
106258hydrocortisone 1 % (as hydrocortisone acetate 1.2 % ) Topical CreamSY2
106258hydrocortisone 1 % Topical CreamSY2
106258hydrocortisone 1 GM per 100 GM Topical CreamSY2

DailyMed Pharmacologic Classes#

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

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130321922096057GTIN-13: 0321922096057
EAN-13: 0321922096057
GTIN-12: 321922096057
UPC-A: 321922096057
GTIN storage (14 digits): 00321922096057
carton28g.jpg

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
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
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
21922-096-04HYDROCORTISONE1 in 1 CARTONCREAM12
21922-096-04HYDROCORTISONE14 g in 1 TUBECREAM142
21922-096-05HYDROCORTISONE28 g in 1 TUBECREAM282
21922-096-05HYDROCORTISONE1 in 1 CARTONCREAM12

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
21922-09621922-096-04, 21922-096-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
12025-02-25full-release2026-06-01 01:14:18

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
HYDROCORTISONEHYDROCORTISONEEncube Ethicals, Inc.969cd576-82d3-4662-bbc1-3587a1f6a5642025-11-10WarningsExact identifier
ndc (package): 21922-096-04
ndc (package): 21922-096-05
ndc (product): 21922-096
ndc11 (package): 21922009605
ndc11 (package): 21922009604
spl id: 00f13ac4-5e1e-4ff8-8a9f-50a7c272ea20
spl set id: 969cd576-82d3-4662-bbc1-3587a1f6a564

Reported adverse events (FAERS/openFDA)#

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