FDA.reportPublic FDA data

0498-0801: 1% Hydrocortisone Cream

Manufacturer
Honeywell Safety Products USA, inc
Effective date
2024-01-22
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
legacy-cache
Hydrated at
2026-08-01 21:13:45

Label at a glance#

ProductHYDROCORTISONE
Active ingredientHYDROCORTISONE ACETATE
Label structure9 sections

Indications and uses

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

Dosage and administration

adults and children 2 years and older: clean the affected area apply to the area not more than 3 to 4 times daily children under 2 years of age: consult a doctor

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

(In each gram)

Hydrocortisone acetate (equivalent to Hydrocortisone 1%)

Purpose

OTC - PURPOSE SECTION

Anti-itch cream

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

For external use only

Ask a doctor before use if

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you are using any other hydrocortisone product

When using the product

OTC - WHEN USING SECTION

  • avoid contact with eyes
  • do not begin use of any other hydrocortisone product unless you have consulted a doctor
  • do not use for the treatment of diaper rash

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • condition worsens
  • condition persists for more than 7 days
  • condition clears up and recurs 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 2 years and older:
  • clean the affected area
  • apply to the area not more than 3 to 4 times daily
  • children under 2 years of age: consult a doctor

Other information

OTHER SAFETY INFORMATION

  • store at room temperature (do not freeze)

Inactive ingredients

INACTIVE INGREDIENT SECTION

cetyl alcohol, citric acid, diazolidinyl urea, edetate disodium, glycerin, glyceryl monostearate, methylparaben, mineral oil, polyethylene glycol, propylene glycol, propylparaben, purified water, stearic acid, trolamine

Questions or comments?

OTC - QUESTIONS SECTION

1-800-430-5490

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

hydrocortisonehydrocortisone

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0498-08010498-0801-03, 0498-0801-02, 0498-0801-01, 0498-0801-32, 0498-0801-33, 0498-0801-34, 0498-0801-35

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
LIGHT MINERAL OILN6K5787QVPIACT
STEARIC ACID4ELV7Z65APIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
CETYL ALCOHOL936JST6JCNIACT
TROLAMINE9O3K93S3TKIACT
METHYLPARABENA2I8C7HI9TIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
DIAZOLIDINYL UREAH5RIZ3MPW4IACT
PROPYLPARABENZ8IX2SC1OHIACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
HYDROCORTISONE ACETATE3X7931PO74ACTIB
EDETATE DISODIUM7FLD91C86KIACT

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
1a8db99f-f13c-cd0b-e063-6394a90a6aea94fc9672-551e-0ad8-e053-2a95a90a837d2024-06-10WarningsExact identifier
spl set id: 94fc9672-551e-0ad8-e053-2a95a90a837d

Reported adverse events (FAERS/openFDA)#

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