HYDROCORTISONE MAXIMUM STRENGTH- hydrocortisone ointment

Hydrocortisone by

Drug Labeling and Warnings

Hydrocortisone by is a Otc medication manufactured, distributed, or labeled by Chain Drug Consortium, LLC, Teva Pharmaceuticals USA, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Hydrocortisone, USP 1%

Purpose

Anti-itch

Uses

    for the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to:
     eczema      insect bites      poison ivy      poison oak      poison sumac      soaps
     jewelry       detergrents      cosmetics      psoriasis         seborrheic dermatitis
for external genital, feminine and anal itching  other uses of this product should be only under the advice and supervision of a doctor

Warnings

For external use only

Do not use

• for external feminine itching if you have a vaginal discharge. Consult a doctor.
• for the treatment of diaper rash. Consult a doctor.

When using this product

• avoid contact with the eyes
• do not begin the use of any other hydrocortisone product unless directed by a doctor
• for external anal itching:
  • do not use more than directed unless directed by a doctor
  • do not put this product into the rectum using fingers or any mechanical device or applicator

Stop use and ask a doctor if

• symptoms last for more than 7 days
• the condition gets worse
• symptoms clear up and occur again in a few days
• rectal bleeding occurs, consult doctor promptly

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 do not use, consult a doctor
For external anal itching
Adults: when practical, clean the affected area with mild soap and warm water, rinse thoroughly, gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product
Children under 12 years of age: consult a doctor

Other information

  Store at room temperature 59º-86ºF (15 -30ºC).
  Before using any medication, read all label directions. Keep carton, it contains important information.

Inactive ingredients

mineral oil, white petrolatum

Questions?

1-800-432-8534 between 9 am and 4 pm EST, Monday–Friday.

PRINCIPAL DISPLAY PANEL

Premier Value®

COMPARE TO THE ACTIVE INGREDIENT IN CORTIZONE10®*

MAXIMUM STRENGTH
Hydrocortisone Ointment, USP 1%
ANTI-ITCH OINTMENT
Relieves Itches and Rashes

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

NET WT 1 OZ (28g)

INGREDIENTS AND APPEARANCE

HYDROCORTISONE  MAXIMUM STRENGTH
hydrocortisone ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68016-009
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
MINERAL OIL (UNII: T5L8T28FGP)
PETROLATUM (UNII: 4T6H12BN9U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68016-009-01	1 in 1 CARTON	09/08/2006
1		28 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 NOT FINAL	part348	09/08/2006

Labeler - Chain Drug Consortium, LLC (101668460)