Hydrocortisone

Manufacturer
Premier Brands of America, Inc.
Effective date
2025-10-27
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:41:02

Label at a glance#

ProductHydrocortisone
Active ingredientHYDROCORTISONE
Label structure8 sections

Indications and uses

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

Dosage and administration

twist cap counterclockwise to unlock actuator adults and children 2 years of age and older: spray affected area not more than 3 to 4 times daily children under 2 years of age: do not use, consult a doctor to apply to face, spray into palm of hand and gently apply

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Hydrocortisone 1%

Purpose

OTC - PURPOSE SECTION

Anti-itch

Uses

INDICATIONS & USAGE SECTION

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

  • eczema
  • insect bites
  • poison ivy
  • poison oak
  • poison sumac
  • soaps
  • jewelry
  • detergents
  • cosmetics
  • seborrheic dermatitis
  • psoriasis
  • other uses of this product should be only under the advice and supervision of a doctor

Warnings

WARNINGS SECTION

For external use only.

Flammable:

SAFE HANDLING WARNING SECTION

Keep away from heat, sparks and open flame. Contents under pressure. Do not puncture or incinerate. Do not store at temperatures above 120 ºF. Intentional misuse by deliberately concentrating and inhaling contents can be harmful or fatal.

Do not use

OTC - DO NOT USE SECTION

  • for external genital, vaginal or anal itching
  • with other hydrocortisone product unless directed by a doctor
  • in or near the eyes
  • for diaper rash

When using this product

OTC - WHEN USING SECTION

  • avoid contact with the eyes
  • if product gets into the eye, flush with water for 15 minutes

Stop use and ask a 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 and do not begin use of any other hydrocortisone product unless you have consulted a doctor

Keep out of the 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

  • twist cap counterclockwise to unlock actuator
  • adults and children 2 years of age and older: spray affected area not more than 3 to 4 times daily
  • children under 2 years of age: do not use, consult a doctor
  • to apply to face, spray into palm of hand and gently apply

Inactive ingredients

INACTIVE INGREDIENT SECTION

aloe barbadensis leaf juice, avena sativa (oat) kernel extract, citric acid, disodium EDTA, ethoxydiglycol, glycerin, maltodextrin, menthyl lactate, methyl gluceth-20, PEG-8, SD alcohol 40-B, sodium citrate, water

Questions ?

OTC - QUESTIONS SECTION

Call 1-866-964-0939

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Cutter
Poison Ivy Itch Relief

For Poison Ivy, Oak, & Sumac

Maximum Strength

Relieves Itching

Calms irritated skin

No touch, no mess

HYDROCORTISONE 1% / ANTI-ITCH

NET WT 4.0 0Z (113 g)

ArtworkArtwork

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
317564hydrocortisone 1 % Topical SprayPSN4
317564hydrocortisone 10 MG/ML Topical SpraySCD4
317564hydrocortisone 1 % Topical SpraySY4

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-130850037540013GTIN-13: 0850037540013
EAN-13: 0850037540013
GTIN-12: 850037540013
UPC-A: 850037540013
GTIN storage (14 digits): 00850037540013
50-119CU_050037540013_Hydrocortisone.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
15bd4439-874a-4934-9954-248e5455d460Product name120260310
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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
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61e59a42-186b-9f4b-aec3-fb49a6debc31Product name120140508
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a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
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fe21f3fd-a378-0654-1972-db3c3b64470eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
56104-250-00Hydrocortisone113 g in 1 CANAEROSOL, SPRAY1134

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
56104-25056104-250-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
32024-10-15full-release2026-06-01 00:25:56

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 CONTINUOUS SPRAYPremier Brands of America, Inc.d344f68b-9b62-3029-e053-2995a90a16652025-10-27WarningsExact identifier
ndc (package): 56104-250-00
ndc (product): 56104-250
ndc11 (package): 56104025000
spl id: 422b3418-94ea-ea94-e063-6294a90ac334
spl set id: d344f68b-9b62-3029-e053-2995a90a1665

Reported adverse events (FAERS/openFDA)#

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