Hydrocortisone Maximum Strength

Hydrocortisone Maximum Strength by

Drug Labeling and Warnings

Hydrocortisone Maximum Strength by is a Otc medication manufactured, distributed, or labeled by H2-Pharma, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HYDROCORTISONE MAXIMUM STRENGTH- hydrocortisone ointment 
H2-Pharma, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Hydrocortisone Maximum Strength

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

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

PRINCIPAL DISPLAY PANEL - 28 g Tube Carton

NDC: 61269-345-56
*Compare to the active ingredient in
Maximum Strength Cortizone 10®

Maximum Strength
Hydrocortisone Ointment, USP 1%

Anti-itch Ointment

For external use only

Relieves itches and rashes
For temporary relief of:
Skin irritations, inflammation, rashes | Insect bites, eczema, psoriasis | Seborrheic dermatitis | Poison ivy, oak, and sumac | External anal and genital itching

Net wt. 1 oz (28 g)

H2 pharma

HYDROCORTISONE MAXIMUM STRENGTH 
hydrocortisone ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	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: 61269-345-56	1 in 1 CARTON	06/29/2021	12/31/2023
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	12/31/2023

Labeler - H2-Pharma, LLC (028473634)

Revised: 2/2023

Document Id: 43b058bb-4e4a-4252-b759-51da5e0732fa

34390-5

Set id: a1bafcb9-6a4d-4b89-8249-cb17528293b8

Version: 3

Effective Time: 20230207