FDA.reportPublic FDA data

Hydrocortisone Cream

Manufacturer
Trifecta Pharmaceuticals USA
Effective date
2025-05-08
Label type
HUMAN OTC DRUG LABEL
Version
11
Source
full-release
Hydrated at
2026-06-01 01:00:42

Label at a glance#

ProductHydrocortisone Cream
Active ingredientHYDROCORTISONE
Label structure14 sections

Indications and uses

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

Dosage and administration

When practical, cleanse 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 adults and children 12 years of age and older, apply to the affected area not more than 3 to 4 times daily children under 12 years of age: do not use, consult a doctor

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

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

Warnings

WARNINGS SECTION

  • for external use only
  • avoid contact with eyes
  • do not put this product into the rectum by using fingers or any mechanical device or applicator

For External Anal Itching Users:

  • do not exceed the recommended daily dosage unless directed by a doctor
  • in case of bleeding, consult a doctor promptly
  • children under 12 years of age: consult a doctor

Before using any medication, read all label directions. Keep this carton as it contains important information

Stop using this product and ask a doctor

OTC - STOP USE SECTION

  • in case of bleeding
  • if condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days
  • before you begin using any other hydrocortisone product

Do not use this product and ask a doctor

OTC - DO NOT USE SECTION

  • If you have a vaginal discharge
  • before treating diaper rash
  • before using on children under 2 years of age

Directions

DOSAGE & ADMINISTRATION SECTION

  • When practical, cleanse 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
  • adults and children 12 years of age and older, apply to the affected area not more than 3 to 4 times daily
  • children under 12 years of age: do not use, consult a doctor

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aloe barbadensis leaf juice, ethylparaben, glycerin, glycerol monostearate, hexadecanol, mineral water, octadecannol, petrolatum, purified water, sodium dodecyl sulfate

Other Information

SPL UNCLASSIFIED SECTION

  • to open; unscrew cap and pull tab to remove foil seal
  • if seal has been broken, do not use this product. Return product to the store where you bought it
  • store at controlled room temperature 15°-30°C (59°-86°F)
  • see carton or tube crimp for lot number and expiration date

Other Information

SPL UNCLASSIFIED SECTION

Distributed By:

Trifecta Pharmaceuticals USA®

101 NE Third Avenue, Suite 1500

Ft. Lauderdale, FL. 33301 USA

www.trifecta-pharma.com

1-888-296-9067

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

4040 GLOBE HYDROCORTISONE CREAM WITH ALOE 1OZ 042525 CDER4040 GLOBE HYDROCORTISONE CREAM WITH ALOE 1OZ 042525 CDER

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

404004-FBA GLOBE HYDROCORTISONE CREAM WITH ALOE 1OZ 4PK_BOX 042525 CDER404004-FBA GLOBE HYDROCORTISONE CREAM WITH ALOE 1OZ 4PK_BOX 042525 CDER

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

404003-FBA GLOBE HYDROCORTISONE CREAM WITH ALOE 1OZ 3PK_BOX 042525 CDER404003-FBA GLOBE HYDROCORTISONE CREAM WITH ALOE 1OZ 3PK_BOX 042525 CDER

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
106258hydrocortisone 1 % Topical CreamPSN11
106258hydrocortisone 10 MG/ML Topical CreamSCD11
106258hydrocortisone 1 % (as hydrocortisone acetate 1.2 % ) Topical CreamSY11
106258hydrocortisone 1 % Topical CreamSY11
106258hydrocortisone 1 GM per 100 GM Topical CreamSY11

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
69396-028-01Hydrocortisone Cream28.4 g in 1 TUBECREAM28.411
69396-028-01Hydrocortisone Cream1 in 1 BOXCREAM111
69396-028-02Hydrocortisone Cream56 g in 1 TUBECREAM5611
69396-028-02Hydrocortisone Cream1 in 1 BOXCREAM111
69396-028-33Hydrocortisone Cream3 in 1 BOXCREAM311
69396-028-33Hydrocortisone Cream28.4 g in 1 TUBECREAM28.411
69396-028-44Hydrocortisone Cream28.4 g in 1 TUBECREAM28.411
69396-028-44Hydrocortisone Cream4 in 1 BOXCREAM411

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69396-028HYDROCORTISONE CREAM (HYDROCORTISONE) CREAM [TRIFECTA PHARMACEUTICALS USA]11Current NDC, Legacy NDC, 8 package rows20250510_4c96ec41-841c-322b-e054-00144ff8d46c.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69396-028-01GM - Gram69396-0288971e9bc-b3c0-4894-bbc5-049a7cf7feaa12019-04-11

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
69396-02869396-028-01, 69396-028-02, 69396-028-44, 69396-028-33

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
POLYSORBATE 60CAL22UVI4MIACT
EDETATE DISODIUM7FLD91C86KIACT
WATER059QF0KO0RIACT
SORBITAN STEARATENVZ4I0H58XIACT
PETROLATUM4T6H12BN9UIACT
ALOE VERA LEAFZY81Z83H0XIACT
HYDROCORTISONEWI4X0X7BPJACTIB
CETYL ALCOHOL936JST6JCNIACT
GLYCERYL MONO- AND DIPALMITOSTEARATEKC98RO82HJIACT
METHYLPARABENA2I8C7HI9TIACT
MINERAL OILT5L8T28FGPIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PROPYLPARABENZ8IX2SC1OHIACT

Source Document#

Source XML · Source PDF

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
Hydrocortisone CreamHYDROCORTISONETrifecta Pharmaceuticals USA4c96ec41-841c-322b-e054-00144ff8d46c2025-05-08WarningsExact identifier
ndc (package): 69396-028-44
ndc (package): 69396-028-33
ndc (package): 69396-028-02
ndc (package): 69396-028-01
ndc (product): 69396-028
ndc11 (package): 69396002802
ndc11 (package): 69396002801
ndc11 (package): 69396002833
ndc11 (package): 69396002844
spl id: 34a27d85-dac3-2169-e063-6294a90ae708
spl set id: 4c96ec41-841c-322b-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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