Hydrocortisone Cream

Hydrocortisone Cream
SPL v5
SPL
SPL Set ID 779f945f-ab69-40de-8d86-ab76debc5c7c
Route
TOPICAL
Published
Effective Date 2024-02-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrocortisone (10 mg)
Inactive Ingredients
Alcohol Methylparaben Mineral Oil Paraffin Propylparaben Water White Wax

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 1974-01-01
Description

Active Ingredient (in each gram): Hydrocortisone Acetate 10mg (equivalent to Hydrocortisone 1%)

Medication Information

Warnings and Precautions

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 clal 911 or your local emergency provider.

Indications and Usage

Dosage and Administration

Directions:

Adults and children 12 years of age and over: apply topically to the area 3 to 4 times daily.

Children under 12 years of age: do not use, ask a doctor

Description

Active Ingredient (in each gram): Hydrocortisone Acetate 10mg (equivalent to Hydrocortisone 1%)

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: emulsifying wax, ethanol, methylparaben, mineral oil, paraffin, petrolatum, propylparaben, purified water, white wax

Section 51945-4

Section 55105-1

Purpose: anti-itch cream

Section 55106-9

Active Ingredient (in each gram): Hydrocortisone Acetate 10mg (equivalent to Hydrocortisone 1%)

Structured Label Content

Indications and Usage (34067-9)

Dosage and Administration (34068-7)

Directions:

Adults and children 12 years of age and over: apply topically to the area 3 to 4 times daily.

Children under 12 years of age: do not use, ask a doctor

Warnings and Precautions (34071-1)

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 clal 911 or your local emergency provider.

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: emulsifying wax, ethanol, methylparaben, mineral oil, paraffin, petrolatum, propylparaben, purified water, white wax

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 Acetate 10mg (equivalent to Hydrocortisone 1%)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:02:47.684098 · Updated: 2026-03-14T23:02:32.213463