Hydrocortisone Maximum Strength: Package Insert and Label Information

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.

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 DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROCORTISONE (HYDROCORTISONE) HYDROCORTISONE 1 g in 100 g

Inactive Ingredients Ingredient Name Strength MINERAL OIL WHITE PETROLATUM

Product Characteristics Color WHITE Score Shape Size Flavor Imprint Code Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:61269-345-56 1 TUBE in 1 CARTON contains a TUBE 1 28 g in 1 TUBE This package is contained within the CARTON (61269-345-56)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 06/29/2021

Labeler — H2-Pharma, LLC (028473634)

Revised: 01/2023 H2-Pharma, LLC