Hydrocortisone Cream

Hydrocortisone Cream
SPL v2
SPL
SPL Set ID c76fb030-cbb5-4773-aa52-d038cb41d0af
Route
TOPICAL
Published
Effective Date 2025-12-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrocortisone (10 mg)
Inactive Ingredients
Cetearyl Alcohol Ceteareth-20 Ethylhexylglycerin Glycerin Mineral Oil White Petrolatum Phenoxyethanol Water Glyceryl Stearate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-08-14

Description

Active Ingredient (in each gram): Hydrocortisone 1%


Medication Information

Dosage and Administration

Directions:

  • Adults and children 12 years of age and over: apply topically to the area not more than 3 to 4 times daily.
  • Children under 12 years of age: ask a doctor
Description

Active Ingredient (in each gram): Hydrocortisone 1%

Uses

Temporarily relieves itching associated with minor skin irritations and rashes due to

  • eczema
  • insect bites
  • poison oak, ivy and sumac
  • soaps and detergents
  • cosmetics
  • jewelry
  • psoriasis
  • seborrheic dermatitis

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

Section 50565-1

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

Section 50566-9

Stop use and ask a doctor if:

  • condition worsens
  • condition lasts for more than 7 days
  • symptoms clear up and occur again within a few days
Section 50570-1

Do not use:

  • in the eyes or over large portions of the body
  • for the treatment of diaper rash
  • with any other hydrocortisone product

Section 51727-6

Inactive Ingredients: Cetearyl Alcohol, Ceteareth-20, Ethylhexylglycerin, Glycerin, Glyceryl Stearate, Mineral Oil, White Petrolatum, Phenoxyethanol, Water

Section 51945-4

Section 55105-1

Purpose: anti-itch cream

Section 55106-9

Active Ingredient (in each gram): Hydrocortisone 1%

Section 60561-8
  • ointment enclosed in a sealed packet
  • avoid excessive heat
  • do not use if packet is torn, cut or open
  • store at 59° to 86°F (15°-30°C)
Warnings: for External Use Only

Do not get in eyes

Allergy alert: A severe allergic reaction to insect bites or stings may require life support measures. In such cases, immediately call 911 or your clocal emergency provider.


Structured Label Content

Uses

Temporarily relieves itching associated with minor skin irritations and rashes due to

  • eczema
  • insect bites
  • poison oak, ivy and sumac
  • soaps and detergents
  • cosmetics
  • jewelry
  • psoriasis
  • seborrheic dermatitis

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

Dosage and Administration (34068-7)

Directions:

  • Adults and children 12 years of age and over: apply topically to the area not more than 3 to 4 times daily.
  • Children under 12 years of age: ask a doctor
Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

Stop use and ask a doctor if:

  • condition worsens
  • condition lasts for more than 7 days
  • symptoms clear up and occur again within a few days
Section 50570-1 (50570-1)

Do not use:

  • in the eyes or over large portions of the body
  • for the treatment of diaper rash
  • with any other hydrocortisone product

Section 51727-6 (51727-6)

Inactive Ingredients: Cetearyl Alcohol, Ceteareth-20, Ethylhexylglycerin, Glycerin, Glyceryl Stearate, Mineral Oil, White Petrolatum, Phenoxyethanol, Water

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose: anti-itch cream

Section 55106-9 (55106-9)

Active Ingredient (in each gram): Hydrocortisone 1%

Section 60561-8 (60561-8)
  • ointment enclosed in a sealed packet
  • avoid excessive heat
  • do not use if packet is torn, cut or open
  • store at 59° to 86°F (15°-30°C)
Warnings: for External Use Only (Warnings: For external use only)

Do not get in eyes

Allergy alert: A severe allergic reaction to insect bites or stings may require life support measures. In such cases, immediately call 911 or your clocal emergency provider.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)