Hydrocortisone

Hydrocortisone
SPL v4
SPL
SPL Set ID ff95a536-35b3-4006-b43c-cce359e86aa9
Route
TOPICAL
Published
Effective Date 2023-04-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrocortisone (10 mg)
Inactive Ingredients
Cetostearyl Alcohol Polyoxyl 20 Cetostearyl Ether Ethylhexylglycerin Glycerin Mineral Oil Petrolatum Phenoxyethanol Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-05-08
Description

Hydrocortisone 1%

Purpose

Anti-itch

Medication Information

Purpose

Anti-itch

Description

Hydrocortisone 1%

Uses
  • for the temporary relief of itching associated with minor irritations and rashes
  • other uses of this product should be only under the advice and superivision of a doctor.
Warnings

For external use only.

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.
Do Not Use

for the treatment of diaper rash. Consult a doctor.

Drug Facts

Active Ingredient

Hydrocortisone 1%

Package Labeling:

Inactive Ingredients

Cetearyl alcohol, Ceteareth-20, Ethylhexylglycerin, Glycerin, Glycerol fatty acid ester, Mineral Oil, Petrolatum, Phenoxyethanol, Water

Stop Use and Ask A Doctor If
  • condition worsens of lasts more than 7 days, or clears up and occurs again within a few days.
  • you begin use of any other hydrocortisone product
  • bleeding occurs
Keep Out of Reach of Children.

If swallowed contact a Poison Control Center right away.

Structured Label Content

Uses
  • for the temporary relief of itching associated with minor irritations and rashes
  • other uses of this product should be only under the advice and superivision of a doctor.
Purpose

Anti-itch

Warnings

For external use only.

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.
Do Not Use (Do not use)

for the treatment of diaper rash. Consult a doctor.

Drug Facts

Active Ingredient (Active ingredient)

Hydrocortisone 1%

Package Labeling:

Inactive Ingredients (Inactive ingredients)

Cetearyl alcohol, Ceteareth-20, Ethylhexylglycerin, Glycerin, Glycerol fatty acid ester, Mineral Oil, Petrolatum, Phenoxyethanol, Water

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • condition worsens of lasts more than 7 days, or clears up and occurs again within a few days.
  • you begin use of any other hydrocortisone product
  • bleeding occurs
Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed contact a Poison Control Center right away.

Advanced Ingredient Data

Raw Label Data

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Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:46.602525 · Updated: 2026-03-14T23:05:42.419463