FDA.reportPublic FDA data

Hydrocortisone

Manufacturer
Derma Care Research Labs, LLC
Effective date
2019-06-14
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 00:21:01

Label at a glance#

ProductHydrocortisone
Active ingredientHYDROCORTISONE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Hydrocortisone 1%

OTC - PURPOSE SECTION

Anti-itch

DOSAGE & ADMINISTRATION SECTION

For the temporary relief of itching associated with minor skin irritations and rashes due to eczema, insect bites, and poison oak.

WARNINGS SECTION

For external use only.

Do not use for the treatment of diaper rash. Ask a doctor.

When using this product use only as directed, avoid contact with eyes or mucous membranes.

Stop use and ask a doctor if condition worsens or symptoms persist for more than 7 days if symptoms clear up and occur again within a few days and do not begin use of any other hydrocortisone product unless you have asked a doctor.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

INDICATIONS & USAGE SECTION

Adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily. Children under 2 years of age: ask a doctor.

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf Extract, Cetearyl Alcohol, Cetyl Alcohol, Chamomilla Recutita (Matricaria) Flower Extract, Dimethicone, Disodium EDTA, Ethylhexylglycerin, Glycerin Methyl Gluceth-20, Petrolatum, Phenoxyethanol, Polysorbate 60, Potassium Hydroxide, Propylene Glycol, Steareth-2, Steareth-21, Stearyl Alcohol, Tocopheryl Acetate, Water.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CartonCarton

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72839-03372839-033-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
STEARYL ALCOHOL2KR89I4H1YIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
CETYL ALCOHOL936JST6JCNIACT
CHAMOMILEFGL3685T2XIACT
DIMETHICONE 3502Y53S6ATLUIACT
WATER059QF0KO0RIACT
HYDROCORTISONEWI4X0X7BPJACTIB
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
METHYL GLUCETH-20J3QD0LD11PIACT
GLYCERINPDC6A3C0OXIACT
PETROLATUM4T6H12BN9UIACT
POLYSORBATE 806OZP39ZG8HIACT
POTASSIUM HYDROXIDEWZH3C48M4TIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
STEARETH-2153J3F32P58IACT
ALOE VERA LEAFZY81Z83H0XIACT

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
b9850246-3a12-2081-e053-2a95a90a98b58b4a447c-30a5-1764-e053-2a95a90a3ec32021-01-22WarningsExact identifier
spl set id: 8b4a447c-30a5-1764-e053-2a95a90a3ec3

Reported adverse events (FAERS/openFDA)#

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