HYDROCORTISONE CREAM USP 1%

Manufacturer
Delsam Pharma Llc
Effective date
2018-09-24
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 00:49:36

Label at a glance#

ProductHYDROCORTISONE
Active ingredientHYDROCORTISONE
Label structure11 sections

Indications and uses

• for temporary relief of itching associated with minor skin irritations and rashes due to: • Eczema • Insect bites • Soaps and detergents  • Cosmetics • Jewelry • Seborrheic dermatitis • Psoriasis • Poison ivy, oak or sumac • For external genital, feminine and anal itching • Other uses of this product should be only under the advice and supervision of a doctor

Dosage and administration

For minor skin irritations and rashes, adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily. For external anal itching: • Adults: when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly • Gently dry by patting or blotting with toilet tissue or soft cloth before application of this product • Children: under 12 years of age, consul...

Storage and handling

• Do not use if seal is damaged or is not visible. To open, unscrew cap, pull tab to remove foil seal • store at room temperature • See crimp of tube or carton for Lot Number and Expiration Date

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Hydrocortisone USP 1%

Purpose

OTC - PURPOSE SECTION

Anti-itch

Uses

INDICATIONS & USAGE SECTION

• for temporary relief of itching associated with minor skin irritations and rashes due to: • Eczema • Insect bites • Soaps and detergents • Cosmetics • Jewelry • Seborrheic dermatitis • Psoriasis • Poison ivy, oak or sumac • For external genital, feminine and anal itching • Other uses of this product should be only under the advice and supervision of a doctor

Warnings

WARNINGS SECTION

For external use only

Do not use • In children under 2 years of age • If you have a vaginal discharge • For the treatment of diaper rash

Ask a doctor before use if you have • External genital or feminine itching • External anal itching • Bleeding

When using this product • Avoid contact with eyes • Do not exceed the recommended daily dosage unless directed by a doctor • Do not put this product into the rectum by using fingers or any mechanical device or applicator

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Directions

DOSAGE & ADMINISTRATION SECTION

For minor skin irritations and rashes, adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily. For external anal itching: • Adults: when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly • Gently dry by patting or blotting with toilet tissue or soft cloth before application of this product • Children: under 12 years of age, consult a doctor.

Inactive ingredients:

INACTIVE INGREDIENT SECTION

Cetostearyl Alcohol, Cetomacrogol 1000, White Petroleum Jelly, Propylene Glycol, Light Liquid Paraffin, Mono basic Sodium Phosphate, Propyl Paraben, Methyl Paraben, Chlorocresol, Purified Water

Other information

STORAGE AND HANDLING SECTION

• Do not use if seal is damaged or is not visible. To open, unscrew cap, pull tab to remove foil seal

• store at room temperature • See crimp of tube or carton for Lot Number and Expiration Date

Questions or comments?

OTC - QUESTIONS SECTION

1-866-826-1306‬ between 9 am and 4 pm EST, Monday-Friday.

SPL UNCLASSIFIED SECTION

MAXIMUM STRENGTH ANTI-ITCH CREAM

Temporary Relief the Discomfort of itching, Rashes and Irritation on Skin Due to Eczema, Psoriasis and Insect bites

Compared to the active ingredient in Cortizone 10

Distributed by:

Delsam Pharma Llc

Bronx, Newyork 10467.

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Hydrocortisone CreamHydrocortisone Cream

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72570-103-302023-03-16C16284748780-19d75b9d0-6394-f424-e053-dadaa90a57ceHYDROCORTISONE CREAM USP 1%
72570-103-302020-01-31C16284748780-19d75b9d0-6394-f424-e053-dadaa90a57ceHYDROCORTISONE CREAM USP 1%

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72570-10372570-103-30

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 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
41990bad-981b-4123-b8a4-2fc576ec2c87f3ddbf5f-4682-4e92-86d3-5f042e826e4a2023-03-15WarningsExact identifier
spl set id: f3ddbf5f-4682-4e92-86d3-5f042e826e4a

Reported adverse events (FAERS/openFDA)#

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