HYDROCORTISONE 1%- hydrocortisone acetate ointment

Hydrocortisone 1% by

Drug Labeling and Warnings

Hydrocortisone 1% by is a Otc medication manufactured, distributed, or labeled by Ezricare Llc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Hydrocortisone Acetate 1%

Purpose

Antipruritic (Anti-itch)

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

Warnings

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

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

Directions

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

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

Mineral Oil, Sorbitan Sesquioleate, White Petrolatum

Questions or comments?

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

INGREDIENTS AND APPEARANCE

HYDROCORTISONE 1% 
hydrocortisone acetate ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79503-103
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROCORTISONE ACETATE (UNII: 3X7931PO74) (HYDROCORTISONE - UNII:WI4X0X7BPJ)	HYDROCORTISONE ACETATE	10 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
MINERAL OIL (UNII: T5L8T28FGP)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
WHITE PETROLATUM (UNII: B6E5W8RQJ4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79503-103-30	1 in 1 CARTON	08/19/2021	07/01/2025
1		30 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	08/19/2021	07/01/2025

Labeler - Ezricare Llc (117573818)