HYDROCORTISONE CREAM

Manufacturer
DIRECT RX
Effective date
2021-09-21
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 22:35:15

Label at a glance#

ProductHYDROCORTISONE
Active ingredientHYDROCORTISONE
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Hydrocortisone 1%

OTC - PURPOSE SECTION

Antipruritic (Anti-itch)

OTC - WHEN USING SECTION

Relieves itches and rashes due to:

Eczema
Psoriasis
Seborrheic dermatitis
Poison ivy
Poison oak
Poison sumac
Insect bites
External anal itching
Soaps
Detergents
Cosmetics
Jewelry

Temporary relief of external anal and genital itching.

Other use of the product should only be under the advice and supervision of a doctor.

WARNINGS SECTION

For external use only

Do not use:

In the eyes
For diaper rash
If you have vaginal discharge
More than the recommended dosage

Ask doctor before use:

If you are pregnant or breast feeding

Stop use and ask a doctor if:

Condition worsens, or is 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 asked a doctor.

​When using this product:

Do not put this product into rectum by using fingers or any mechanical device or applicator.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center right away

OTC - PURPOSE SECTION

Adults and children over 2 years of age - Apply to affected area not more than 3-4 times per day.
Children under 2 years of age - Do not use. Consult a doctor.

For external anal itching Adults - When practical cleanse the affcted area with mild soap and water and rinse thoroughly. Gently dry patting with bathroom tissue or soft cloth before applying. ​Apply to affected area not more than 3-4 times per day. Children under 12 years of age: consult a doctor.

OTHER SAFETY INFORMATION

store between 20ºC and 25ºC (68ºFk and 77ºF)
avoid excessive heat and humidity

INACTIVE INGREDIENT SECTION

Cetomacrogol 1000, Cetostearyl alcohol, Chlorocresol, Disodium EDTA, Liquid paraffin, Propylene glycol, Purified water, Sodium metabisulphite, White soft paraffin.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

276276

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72189-276-28GM - Gram72189-276299cf256-53a4-4510-8368-2b054466caec12021-11-09
70512-101-30GM - Gram70512-10163cc083c-6e85-434c-9785-501ae92e4f1212020-08-06

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72189-27672189-276-28
70512-101

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 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
074aa01c-4b42-5382-e063-6394a90abefbcc82086b-3034-1805-e053-2a95a90af0bd2023-10-09WarningsExact identifier
spl set id: cc82086b-3034-1805-e053-2a95a90af0bd

Reported adverse events (FAERS/openFDA)#

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