HYDROCORTISONE MAXIMUM STRENGTH- hydrocortisone ointment

Hydrocortisone Maximum Strength by

Drug Labeling and Warnings

Hydrocortisone Maximum Strength by is a Otc medication manufactured, distributed, or labeled by A-S Medication Solutions. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

Active ingredient

Hydrocortisone USP, 1%

Purpose

Anti-itch

Uses

• temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to
  • eczema
  • psoriasis
  • insect bites
  • poison ivy, oak, sumac
  • detergents
  • jewelry
  • cosmetics
  • soaps
  • seborrheic dermatitis
• temporarily relieves external anal and genital 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

• in the genital area 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 use more than directed unless directed by a doctor
• do not put directly into the rectum by using fingers or any mechanical device or applicator

Stop use and ask a doctor if

• condition worsens, symptoms persist for more than 7 days or clear up and occur again within a few days
• do not begin the use of any other hydrocortisone product unless directed by a doctor
• rectal bleeding occurs

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

• for itching of skin irritation, inflammation, and rashes
  • 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
• for external anal and genital 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
  • apply to affected area not more than 3 to 4 times daily
  • children under 12 years of age: consult a doctor

Other information

• store at 15°-30°C (59°-86°F). Protect from freezing.
• before using any medication, read all label directions. Keep carton, it contains important information.

Inactive ingredients

mineral oil, white petrolatum

Questions or comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

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Distributed by: H2-Pharma, LLC
Montgomery, AL 36117

HOW SUPPLIED

Product: 50090-5856

NDC: 50090-5856-0 28 g in a TUBE / 1 in a CARTON

hydrocortisone

INGREDIENTS AND APPEARANCE

HYDROCORTISONE MAXIMUM STRENGTH 
hydrocortisone ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50090-5856(NDC:61269-345)
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)
WHITE PETROLATUM (UNII: B6E5W8RQJ4)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50090-5856-0	1 in 1 CARTON	11/12/2021
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	06/29/2021

Labeler - A-S Medication Solutions (830016429)

Establishment
Name	Address	ID/FEI	Business Operations
A-S Medication Solutions		830016429	RELABEL(50090-5856)