SPL v2
SPL
SPL Set ID 027fae33-93a0-a61f-e063-6294a90a990f
Route
TOPICAL
Published
Effective Date 2023-12-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrocortisone (1 g)
Inactive Ingredients
Water Alcohol Dimethyl Isosorbide Glycerin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-12-27
Description

Hydrocortisone 1%

Medication Information

Warnings and Precautions

For external use only.

Flammable. Keep away from fire or flame.

Do not use for the treatment of diaper rash. Consult a doctor.

When using this product

  • avoid contact with eyes. In case of contact with eyes, flush thoroughly with water
  • avoid contact with broken skin
  • do not inhale or ingest
  • contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120F.

Stop use and ask a doctor if

condition worsens

symptoms last more than 7 days or clear up and occur again within a few days.

Indications and Usage

For the temporary relief of itching associated with minor skin irritation and rashes due to

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

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

Dosage and Administration

Adults and children 2 years or older: apply to affected area not more than 3 to 4 times daily

Children under 2 years of age: ask a doctor

To apply to face, spray into palm of hand and gently apply.

Description

Hydrocortisone 1%

Section 50565-1

If product is swallowed, get medical help or contact a Poison Control Center right away.

Section 51727-6

Alcohol denat., dimethyl isosorbide, glycerin, water.

Section 51945-4

Section 55105-1

Anti-itch

Section 55106-9

Hydrocortisone 1%

Structured Label Content

Indications and Usage (34067-9)

For the temporary relief of itching associated with minor skin irritation and rashes due to

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

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

Dosage and Administration (34068-7)

Adults and children 2 years or older: apply to affected area not more than 3 to 4 times daily

Children under 2 years of age: ask a doctor

To apply to face, spray into palm of hand and gently apply.

Warnings and Precautions (34071-1)

For external use only.

Flammable. Keep away from fire or flame.

Do not use for the treatment of diaper rash. Consult a doctor.

When using this product

  • avoid contact with eyes. In case of contact with eyes, flush thoroughly with water
  • avoid contact with broken skin
  • do not inhale or ingest
  • contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120F.

Stop use and ask a doctor if

condition worsens

symptoms last more than 7 days or clear up and occur again within a few days.

Section 50565-1 (50565-1)

If product is swallowed, get medical help or contact a Poison Control Center right away.

Section 51727-6 (51727-6)

Alcohol denat., dimethyl isosorbide, glycerin, water.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Anti-itch

Section 55106-9 (55106-9)

Hydrocortisone 1%

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:36.427705 · Updated: 2026-03-14T23:02:15.001245