EZRI CARE TM Hydrocortisone Ointment USP 1%

Manufacturer
Ezricare Llc
Effective date
2024-01-11
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 21:14:45

Label at a glance#

ProductHydrocortisone 1%
Active ingredientHYDROCORTISONE ACETATE
Label structure10 sections

Indications and uses

For temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, psoriasis and for external genital, feminine, and anal itching

Dosage and administration

• 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: consult a doctor. • When used for anal itching, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry, patting or blotting with bathroom tissue or soft cloth before applying. Children under 12: consult a doctor before using for anal itching.

Storage and handling

• Do not use if seal on the tube is damaged or is not visible. To open, unscrew cap, pull tab to remove foil seal • Store at room temperature • Avoid excessive heat • See crimp of tube or carton for Lot Number and Expiry Date

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Hydrocortisone Acetate 1%

Purpose

OTC - PURPOSE SECTION

Antipruritic (Anti-itch)

Uses

INDICATIONS & USAGE SECTION

For temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, psoriasis and for external genital, feminine, and anal itching

Warnings

WARNINGS SECTION

For external use only

If pregnant or breast-feeding, ask a health professional before use

Do not use • in the eyes • for diaper rash • for external genital or feminine itching if you have a vaginal discharge • more than the recommended daily dosage unless directed by a doctor • this product in the rectum by using finger or any mechanical device or applicator

Stop use and ask a doctor if • condition worsens or if symptoms persist more than 7 days or clear up and occur again within a few days. Do not continue to use this or any other hydrocortisone product for longer than 7 days, or if bleeding occurs near anus when used for anal itching

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.

Directions

DOSAGE & ADMINISTRATION 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: consult a doctor. • When used for anal itching, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry, patting or blotting with bathroom tissue or soft cloth before applying. Children under 12: consult a doctor before using for anal itching.

Other information

STORAGE AND HANDLING SECTION

• Do not use if seal on the tube is damaged or is not visible. To open, unscrew cap, pull tab to remove foil seal • Store at room temperature
• Avoid excessive heat • See crimp of tube or carton for Lot Number and Expiry Date

Inactive ingredients

INACTIVE INGREDIENT SECTION

Mineral Oil, Sorbitan Sesquioleate, White Petrolatum

Questions or comments?

OTC - QUESTIONS SECTION

718-502-6610 between 9 am to 4 pm EST, Monday-Friday.

SPL UNCLASSIFIED SECTION

Maximum Strength Anti-itch Ointment

Compared to the active ingredient in Cortizone •10®*

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

*This product is not affiliated with, manufactured by, or produced by the makers or owners of Cortizone • 10®

Distributed by:

EzriCare, LLC

Lakewood, NJ

www.EzriCare.com

Made in India

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Ezricare-103Ezricare-103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79503-103HYDROCORTISONE 1% (HYDROCORTISONE ACETATE) OINTMENT [EZRICARE LLC]2Legacy NDC20240112_1ccb2b62-8dae-4840-bde6-e4b9ed764857.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
79503-103-30GM - Gram79503-103c15c8ecb-81a7-4d96-8864-98a3826095aa12022-05-04

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79503-10379503-103-30

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 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
90838075-1bd2-4c22-b31e-fb4393ec2b481ccb2b62-8dae-4840-bde6-e4b9ed7648572024-01-11WarningsExact identifier
spl id: 90838075-1bd2-4c22-b31e-fb4393ec2b48
spl set id: 1ccb2b62-8dae-4840-bde6-e4b9ed764857

Reported adverse events (FAERS/openFDA)#

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