Medpura

Medpura
SPL v7
SPL
SPL Set ID fa956b6a-1712-4f7a-9490-11866dcd17c8
Route
TOPICAL
Published
Effective Date 2026-01-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrocortisone (1 mg)
Inactive Ingredients
Aloe Cetostearyl Alcohol Ethylparaben Glycerin Glyceryl Monostearate Mineral Oil Petrolatum Laureth-23 Water Stearic Acid

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-01-06

Description

Hydrocortisone 1%

Purpose

Anti-itch


Medication Information

Purpose

Anti-itch

Description

Hydrocortisone 1%

Uses

temporarily relieves itching associated with minor skin irritations, inflammation and rashes due to:

  • eczema
  • insect bites
  • poison ivy, oak or sumac
  • soaps
  • detergents
  • cosmetics
  • jewelry,
  • seborrheic dermatitis
  • psoriasis
  • temporarily relieves external anal and genital itching
  • Other uses of this product should only be under the advice and supervision of a doctor.
Section 42229-5

Manufactured for:

Akron Pharma, Inc.

Fairfield, NJ 07004

www.akronpharma.com

Section 51945-4

Warnings

For external use only.

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: ask a doctor

for external anal and genital itching, adults:

  • when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly
  • gently dry by patting or blotting with toilet tissue or a soft cloth before applying
  • apply to affected area not more than 3 to 4 times daily
  • children under 12 years of age: ask a doctor
Do Not Use
  • in the genital area if you have a vaginal discharge.
  • for the treatment of diaper rash, Consult a doctor.
Active Ingredient

Hydrocortisone 1%

Other Information

store at room temperature 20 0-25 0C (68 0-77 0F).

Inactive Ingredients

Aloe oil, Cetostearyl Alcohol, Ethylparaben, Glycerin, Glyceryl Monostearate, Mineral Oil, Petrolatum, Polyoxyl lauryl ether, Purified water, Stearic Acid

Questions Or Comments?

Call toll-free 1-877-225-6999

When Using This Product
  • avoid contact with eyes
  • do not use more than directed unless told to do so 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, and do not begin use of any other hydrocortisone product unless you have asked a doctor
  • rectal bleeding occurs.
Keep Out of Reach of Children

If swallowed, get medical help or contact Poison Control Center right away (1-800-222-1222).


Structured Label Content

Uses

temporarily relieves itching associated with minor skin irritations, inflammation and rashes due to:

  • eczema
  • insect bites
  • poison ivy, oak or sumac
  • soaps
  • detergents
  • cosmetics
  • jewelry,
  • seborrheic dermatitis
  • psoriasis
  • temporarily relieves external anal and genital itching
  • Other uses of this product should only be under the advice and supervision of a doctor.
Section 42229-5 (42229-5)

Manufactured for:

Akron Pharma, Inc.

Fairfield, NJ 07004

www.akronpharma.com

Section 51945-4 (51945-4)

Purpose

Anti-itch

Warnings

For external use only.

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: ask a doctor

for external anal and genital itching, adults:

  • when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly
  • gently dry by patting or blotting with toilet tissue or a soft cloth before applying
  • apply to affected area not more than 3 to 4 times daily
  • children under 12 years of age: ask a doctor
Do Not Use (Do not use)
  • in the genital area if you have a vaginal discharge.
  • for the treatment of diaper rash, Consult a doctor.
Active Ingredient

Hydrocortisone 1%

Other Information

store at room temperature 20 0-25 0C (68 0-77 0F).

Inactive Ingredients

Aloe oil, Cetostearyl Alcohol, Ethylparaben, Glycerin, Glyceryl Monostearate, Mineral Oil, Petrolatum, Polyoxyl lauryl ether, Purified water, Stearic Acid

Questions Or Comments? (Questions or Comments?)

Call toll-free 1-877-225-6999

When Using This Product (When using this product)
  • avoid contact with eyes
  • do not use more than directed unless told to do so 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 (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, and do not begin use of any other hydrocortisone product unless you have asked a doctor
  • rectal bleeding occurs.
Keep Out of Reach of Children (Keep out of Reach of Children)

If swallowed, get medical help or contact Poison Control Center right away (1-800-222-1222).


Advanced Ingredient Data


Raw Label Data

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