HYDROCORTISONE- hydrocortisone 1% ointment

Hydrocortisone by

Drug Labeling and Warnings

Hydrocortisone by is a Otc medication manufactured, distributed, or labeled by Weeks & Leo Co., Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Hydrocortisone 1%

Purpose

Anti-itch

Uses

For the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to:

• eczema
• seborrheic dermatitis
• poison ivy, poison oak, and poison sumac
• psoriasis
• insect bites
• cosmetics
• jewelry
• detergents
• soaps

temporarily relieves external anal and genital itching

other uses of this product should be only under the advise and supervision of a doctor

Warnings

For external use only

Do not use

• for the treatment of diaper rash. Ask a doctor.
• for external genital itching if you have a vaginal discharge. Ask a doctor.
• for external anal itching if rectal bleeding occurs. Consult a doctor promptly.

When using this product

• do not get in the eyes
• for external anal itching, do not use more than directed unless told to do so by a doctor
• do not put into the rectum by using fingers or any mechanical device or applicator

Stop use and ask a doctor if

• condition gets worse, or if symptoms last for more than 7 days or clear up and occur again within a few days. Do not begin use of any other hydrocortisone product.

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 and over: apply to affected area not more than 3 to 4 times daily

children under 2 years: ask a doctor

for external anal itching in adults:

• when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly, or by patting or blotting with an appropriate cleansing pad
• gently dry by patting or blotting with toilet tissue or a soft cloth before applying

for external anal itching in children under 12 years: ask a doctor

Other information

• store at 20ºC to 25ºC (68ºF to 77ºF)

Inactive ingredient

white petrolatum

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HYDROCORTISONE 
hydrocortisone 1% ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11383-268
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ)	HYDROCORTISONE	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WHITE PETROLATUM (UNII: B6E5W8RQJ4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11383-268-01	28 g in 1 TUBE; Type 0: Not a Combination Product	10/01/2023
2	NDC: 11383-268-02	59 g in 1 TUBE; Type 0: Not a Combination Product	10/01/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	10/01/2023

Labeler - Weeks & Leo Co., Inc. (005290028)

Establishment
Name	Address	ID/FEI	Business Operations
Weeks & Leo Co., Inc.		005290028	manufacture(11383-268)