Hydrocortisone Cream

Hydrocortisone Cream
SPL v1
SPL
SPL Set ID 97caf1c9-1159-40f9-aa2a-a9be6cc2563d
Route
TOPICAL
Published
Effective Date 2010-07-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrocortisone (10 mg)
Inactive Ingredients
Alcohol Methylparaben Mineral Oil Paraffin Petrolatum Propylparaben Water Cetostearyl Alcohol Polysorbate 60 Peg-150 Distearate Steareth-20

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2010-07-28
Description

Drug Facts

Medication Information

Description

Drug Facts

Uses:

For temporary relief of itching associated with minor skin irritations, inflammation or rashes. Other uses of product should be only under the advice and supervision of a doctor.

Section 42229-5

Drug Facts

Warnings

For external use only

Directions
  • apply to affected area not more than 3 to 4 times daily
  • children under 2: ask a doctor
Do Not Use
  • in eyes
  • for treatment of diaper rash
Active Ingredient

Hydrocortisone 1.0%

Inactive Ingredients

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

Stop Use, As A Doctor
  • if condition worsens or lasts more than 7 days, or clears up and occurs again within a few days
  • with use of other hydrocortisone products
Principle Display Panel

HYDROCORTISONE CREAM

1/32 oz. (0.9g)

Dist by:UniShield

San Fernando, CA 91340

ACTIVE INGREDIENT

Hydrocortisone 1.0%

USES: For temporary relief

of itching associated with

minor skin irritations, inflammation or rashes.

Other uses of product

should be only under

the advice and supervision

of a doctor.

Keep Out of Reach of Children.

If ingested, contact a Poison Control Center right away

Structured Label Content

Uses: (USES:)

For temporary relief of itching associated with minor skin irritations, inflammation or rashes. Other uses of product should be only under the advice and supervision of a doctor.

Section 42229-5 (42229-5)

Drug Facts

Warnings

For external use only

Directions
  • apply to affected area not more than 3 to 4 times daily
  • children under 2: ask a doctor
Do Not Use (Do not use)
  • in eyes
  • for treatment of diaper rash
Active Ingredient (ACTIVE INGREDIENT)

Hydrocortisone 1.0%

Inactive Ingredients (Inactive ingredients)

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

Stop Use, As A Doctor (Stop use, as a doctor)
  • if condition worsens or lasts more than 7 days, or clears up and occurs again within a few days
  • with use of other hydrocortisone products
Principle Display Panel (PRINCIPLE DISPLAY PANEL)

HYDROCORTISONE CREAM

1/32 oz. (0.9g)

Dist by:UniShield

San Fernando, CA 91340

ACTIVE INGREDIENT

Hydrocortisone 1.0%

USES: For temporary relief

of itching associated with

minor skin irritations, inflammation or rashes.

Other uses of product

should be only under

the advice and supervision

of a doctor.

Keep Out of Reach of Children. (Keep out of reach of children.)

If ingested, contact a Poison Control Center right away

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:07.123834 · Updated: 2026-03-14T22:52:27.184723