HYDROCORTISONE

Manufacturer
Kinray Inc. | Dynarerx Corporation
Effective date
2017-06-14
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:15:39

Label at a glance#

ProductHYDROCORTISONE
Active ingredientHYDROCORTISONE
Label structure10 sections

Indications and uses

in the eyes longer than 1 week unless directed by a physician for diaper rash if you have vaginal discharge more than the recommended daily dosage unless directed by a doctor in the rectum bu using fingers or any other mechanical device or applicator For temporary relief of minor skin irritations and external itching.

Dosage and administration

Adults and children over 2 years of age Apply evenly to affected area no more than 3 or 4 times daily. Children under 2 years of age Do not use consult a physician Adults When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly Gently dry, patting and blotting with bathroom tissue or soft cloth before applying apply externally to the area up to 6 times daily or after each bowel ...

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient                            Purpose

Hydrocortisone 1%            Antipruritic (anti-itch)

Warnings:

WARNINGS SECTION

For external use only

Purpose

OTC - PURPOSE SECTION

Hydrocortisone is for temporary relief of;


minor skin irritations
Itching and rashes due to;
eczema
insect bites
poison ivy
poison oak
poison sumac
soaps
detergents
cosmetics
jewelry

and for external itching of;
genital
feminine and
anal itching

Indications and Usage

INDICATIONS & USAGE SECTION

  • in the eyes
  • longer than 1 week unless directed by a physician
  • for diaper rash
  • if you have vaginal discharge
  • more than the recommended daily dosage unless directed by a doctor
  • in the rectum bu using fingers or any other mechanical device or applicator
  • For temporary relief of minor skin irritations and external itching.

Stop use and ask a physician if:

OTC - STOP USE SECTION

  • the condition persists or gets worse
  • symptoms clear up and occur again within a few days
  • you are pregnant or breast feeding

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.

Dosage and Administration

DOSAGE & ADMINISTRATION SECTION

Adults and children over 2 years of age
  • Apply evenly to affected area no more than 3 or 4 times daily.
Children under 2 years of age
  • Do not use
  • consult a physician
Adults
  • When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly
  • Gently dry, patting and blotting with bathroom tissue or soft cloth before applying
  • apply externally to the area up to 6 times daily or after each bowel movement

Other information:

SPL UNCLASSIFIED SECTION

  • Store at 20 deg - 25 deg C (68 deg - 77 deg F)
  • Avoid excessive heat and humidity

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Cetostearyl alcohol, glyceryl monostearate, mrthylchloroisothiazolinone, propylene glycol, purified water, stearic acid, triethanolamine, white soft paraffin.

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

KR-1139

Hydrocortisone248.jpg

HydrocortisoneHydrocortisone

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63777-248-012025-05-20C16284748780-19d75b9d0-8c9e-f424-e053-dadaa90a57ceHydrocortisone
63777-248-012020-01-31C16284748780-19d75b9d0-8c9e-f424-e053-dadaa90a57ceHydrocortisone

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63777-24863777-248-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

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
d400789c-b96f-4eb5-a8a8-ef52b6733fc42b36f50b-2ca9-4c52-a6fa-a9d70851d80e2025-05-15WarningsExact identifier
spl set id: 2b36f50b-2ca9-4c52-a6fa-a9d70851d80e

Reported adverse events (FAERS/openFDA)#

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