FDA.reportPublic FDA data

HYDROCORTISONE CREAM 1%

Manufacturer
JHK Inc dba American Safety & First Aid
Effective date
2024-04-25
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:12:03

Label at a glance#

ProductHYDROCORTISONE
Active ingredientHYDROCORTISONE ACETATE
Label structure10 sections

Dosage and administration

Adults and children two years and over: apply to affected area not more than three to four times daily Children under two years: Do not use

Storage and handling

Do not use if packet is torn, cut or opened Store at room temperature (do not freeze) See packet for Lot Number and expiration date

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Hydrocortisone acetate 1%

Purpose

OTC - PURPOSE SECTION

Anti-Itch Cream

Use

INDICATIONS & USAGE SECTION

Temporarily relieves itching associated with minor skin irritations and rashes due to:

  • Eczema
  • Insect Bites
  • Poison Ivy, Oak or Sumac
  • Soaps, Detergents or Cosmetics
  • Jewelry

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

  • With any other hydrocortisone product unless you have consulted a doctor
  • For the treatment of diaper rash, consult a doctor

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • Condition worsens
  • Symptoms persist for more than seven days
  • Symptoms clear up and occur again within a few days

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

  • Adults and children two years and over: apply to affected area not more than three to four times daily
  • Children under two years: Do not use

Other Information

STORAGE AND HANDLING SECTION

  • Do not use if packet is torn, cut or opened
  • Store at room temperature (do not freeze)
  • See packet for Lot Number and expiration date

Inactive ingredient

INACTIVE INGREDIENT SECTION

Cetearyl alcohol, Ceteareth-20, Ethylhexylglycerin/Phenoxyethanol Glycerin, Glycerol fatty acid ester Mineral Oil, Petrolatum, Water

Questions?

OTC - QUESTIONS SECTION

1-866-651-3660 Monday-Friday

8:00am-5:00pm EST

PRINCIPAL DISPLAY PANEL - 25 Packet Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Product #1014

Hydrocortisone Cream
USP 1%

For the temporary relief of itching
associated with minor skin
irritations and rashes.

25 - Unit Dose Packets

PRINCIPAL DISPLAY PANEL - 25 Packet Carton
PRINCIPAL DISPLAY PANEL - 25 Packet Carton

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73598-1014-12024-05-06C16284748780-11030e365-0a9a-111a-e063-dadaa90a10e2HYDROCORTISONE CREAM 1%
73598-1014-12024-01-30C16284748780-11030e365-0a9a-111a-e063-dadaa90a10e2HYDROCORTISONE CREAM 1%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73598-1014-1HYDROCORTISONE25 in 1 CARTONCREAM252
73598-1014-1HYDROCORTISONE1 g in 1 PACKETCREAM12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73598-1014HYDROCORTISONE (HYDROCORTISONE ACETATE) CREAM [JHK INC DBA AMERICAN SAFETY & FIRST AID]2Current NDC, Legacy NDC, 2 package rows20240507_64adc8d0-7ca4-4c1a-813f-f1df47e916f2.zip

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73598-101473598-1014-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
HYDROCORTISONE ACETATE3X7931PO74ACTIB
CETOSTEARYL ALCOHOL2DMT128M1SIACT
POLYOXYL 20 CETOSTEARYL ETHERYRC528SWUYIACT
PETROLATUM4T6H12BN9UIACT
WATER059QF0KO0RIACT

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
HYDROCORTISONEHYDROCORTISONE ACETATEJHK Inc dba American Safety & First Aid64adc8d0-7ca4-4c1a-813f-f1df47e916f22024-04-25WarningsExact identifier
ndc (package): 73598-1014-1
ndc (product): 73598-1014
ndc11 (package): 73598101401
spl id: 10a607b9-d690-40aa-b3d6-d2f5000a398b
spl set id: 64adc8d0-7ca4-4c1a-813f-f1df47e916f2

Reported adverse events (FAERS/openFDA)#

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