HYDROCORTISONE MAXIMUM STRENGTH- hydrocortisone ointment

Hydrocortisone by

Drug Labeling and Warnings

Hydrocortisone by is a Otc medication manufactured, distributed, or labeled by Proficient Rx LP. 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
• detergents
• 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 by 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 59°-86°F (15°-30°C).
• 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

Distributed by:

Actavis Pharma Inc.

Parsippany, NJ 07054

Relabeled by:

Proficient Rx LP

Thousand Oaks, CA 91320

Proficient Rx
NDC: 71205-034-30
Compare to the active ingredient in Cortizone10®*

Maximum Strength
Hydrocortisone Ointment, USP 1%
Anti-Itch Ointment

Relieves Itches and Rashes
Net wt. 1 oz (28g)

For the temporary relief of itches and rashes due to:
Insect Bites      Eczema      Seborrheic dermatitis
Poison Ivy, oak & sumac

INGREDIENTS AND APPEARANCE

HYDROCORTISONE  MAXIMUM STRENGTH
hydrocortisone ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71205-034(NDC:0472-0345)
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: 71205-034-30	1 in 1 CARTON	05/01/2018
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	07/21/1998

Labeler - Proficient Rx LP (079196022)

Establishment
Name	Address	ID/FEI	Business Operations
Proficient Rx LP		079196022	RELABEL(71205-034)