Hydrocortisone

Hydrocortisone
SPL v2
SPL
SPL Set ID 8f351b04-8f6d-4353-9100-13a8a80d656a
Route
TOPICAL
Published
Effective Date 2024-12-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrocortisone (1.14 g)
Inactive Ingredients
Stearic Acid Propylene Glycol Lanolin Alcohols Mineral Oil Myristic Acid Cetyl Alcohol Polysorbate 80 Sorbitan Monooleate Water Methylparaben Propylparaben

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-06-12

Description

Drug Facts

Purpose

Anti-itch


Medication Information

Purpose

Anti-itch

Description

Drug Facts

Uses

For the temporary relief associated with minor skin irritations, inflammation and rashes due to:

  • eczema
  • seborrheic dermatitis
  • psoriasis
  • insect bites
  • poison ivy, oak, sumac
  • soaps
  • detergents
  • cosmetics
  • jewelry
  • external genital and anal itching.

Other uses of this product should be only under the advice and supervision of a doctor.

Section 42229-5

Drug Facts

Section 50565-1

Keep this and all drugs out of the reach of children

Warnings
  • For external use only
  • avoid contact with the eyes
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
Active Ingredient

Hydrocortisone 1%

Other Information
  • store at 55 to 76F
Inactive Ingredients

stearic acid, propylene glycol, lanolin alcohol in mineral oil, isopropyl in myristate, cetyl alcohol, mono- and di-glycerides, polysorbate 80, sorbitan monooleate, a scent and purified water preserved with methylparaben and propylparaben.

For External Anal Itching Users
  • do not exceed the recommended daily dosage unless directed by a doctor
  • in case of bleeding, consult a doctor promptly
  • do not put this product into the rectum by using fingers or any mechanical device or applicator
Do Not Use This Product and Ask A Doctor
  • if you have a vaginal discharge
  • before treating diaper rash
  • before using on children under 2 years of age
Stop Using This Product and Ask A Doctor
  • if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days
  • before you begin using any other hydrocortisone product
Principal Display Panel 114 G Bottle Label

0394-0859-32

Mericon Industries, Inc.

Hydrocortisone 1%

Lotion

Anti-Itch

Poison Ivy

Poison Oak

Poison Sumac

Hives • Rashes

Net Wt. 4 oz. (114g)


Structured Label Content

Uses

For the temporary relief associated with minor skin irritations, inflammation and rashes due to:

  • eczema
  • seborrheic dermatitis
  • psoriasis
  • insect bites
  • poison ivy, oak, sumac
  • soaps
  • detergents
  • cosmetics
  • jewelry
  • external genital and anal itching.

Other uses of this product should be only under the advice and supervision of a doctor.

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep this and all drugs out of the reach of children

Purpose

Anti-itch

Warnings
  • For external use only
  • avoid contact with the eyes
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
Active Ingredient

Hydrocortisone 1%

Other Information
  • store at 55 to 76F
Inactive Ingredients

stearic acid, propylene glycol, lanolin alcohol in mineral oil, isopropyl in myristate, cetyl alcohol, mono- and di-glycerides, polysorbate 80, sorbitan monooleate, a scent and purified water preserved with methylparaben and propylparaben.

For External Anal Itching Users (For external anal itching users)
  • do not exceed the recommended daily dosage unless directed by a doctor
  • in case of bleeding, consult a doctor promptly
  • do not put this product into the rectum by using fingers or any mechanical device or applicator
Do Not Use This Product and Ask A Doctor (Do not use this product and ask a doctor)
  • if you have a vaginal discharge
  • before treating diaper rash
  • before using on children under 2 years of age
Stop Using This Product and Ask A Doctor (Stop using this product and ask a doctor)
  • if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days
  • before you begin using any other hydrocortisone product
Principal Display Panel 114 G Bottle Label (PRINCIPAL DISPLAY PANEL - 114 g Bottle Label)

0394-0859-32

Mericon Industries, Inc.

Hydrocortisone 1%

Lotion

Anti-Itch

Poison Ivy

Poison Oak

Poison Sumac

Hives • Rashes

Net Wt. 4 oz. (114g)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)