Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID faa803e6-453c-4d86-85dd-5a5dcdd72d02
Route
TOPICAL
Published
Effective Date 2015-05-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrocortisone (1 mg)
Inactive Ingredients
Lecithin, Soybean Polyhydroxystearic Acid (2300 Mw) Citric Acid Monohydrate Gag Ascorbyl Palmitate Ascorbic Acid Safflower Polyethylene Glycol 400 Dimethicone Phenoxyethanol Acetate Ion Medium-chain Triglycerides Triethoxycaprylylsilane Isostearic Acid Tocopherol Ethylhexylglycerin Polyglyceryl-3 Pentaricinoleate Titanium Dioxide Hexylene Glycol Petrolatum Safflower Oil Zinc Oxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2015-05-12
Description

Active Ingredient: Hydrocortisone 1%

Medication Information

Warnings and Precautions

Warnings:

  • For external use only.
  • Ask a doctor if bleeding occurs or conditions worsens.
Indications and Usage

Uses:

  • Promotes healing of itchy skin.
  • Keeps skin hydrated.
Dosage and Administration

Directions:

  • Occlude eyebrows, outer corners of eyes, nose and lips prior to chemical peel.
Description

Active Ingredient: Hydrocortisone 1%

Section 50565-1

Keep out of reach of children:

  • If swallowed, get medical help or contact a Poison Control Center right away.
Section 50566-9

Stop use and ask a doctor - If conditions worsens.

Section 50567-7

When using this Product:

  • Avoid contact with the eyes, lips and mouth.
  • Do not use more than directed unless told to do so by a doctor.
Section 50570-1

Do not use - If rashes appear on skin.

Section 51727-6

Inactive Ingredients:

Petrolatum, Carthamus Tinctorius (Safflower) Seed Oil, Tocopheryl Acetate, Zinc Oxide , Titanium Dioxide, Caprylic/Capric Triglyceride, Glyceryl Isostearate, Polyhydroxystearic Acid , Glycosaminoglycans, Dimethicone, Triethoxycaprylylsilane, PEG-8 , Tocopherol , Ascorbyl Palmitate , Ascorbic Acid, Citric Acid

Section 51945-4

Manufactured for DermaQuest®, Inc.

Hayward, CA 94544

1272 GK, NL Made in USA

dermaquestinc.com

Section 55105-1

Purpose: Anti-itch

Section 55106-9

Active Ingredient: Hydrocortisone 1%

Structured Label Content

Indications and Usage (34067-9)

Uses:

  • Promotes healing of itchy skin.
  • Keeps skin hydrated.
Dosage and Administration (34068-7)

Directions:

  • Occlude eyebrows, outer corners of eyes, nose and lips prior to chemical peel.
Warnings and Precautions (34071-1)

Warnings:

  • For external use only.
  • Ask a doctor if bleeding occurs or conditions worsens.
Section 50565-1 (50565-1)

Keep out of reach of children:

  • If swallowed, get medical help or contact a Poison Control Center right away.
Section 50566-9 (50566-9)

Stop use and ask a doctor - If conditions worsens.

Section 50567-7 (50567-7)

When using this Product:

  • Avoid contact with the eyes, lips and mouth.
  • Do not use more than directed unless told to do so by a doctor.
Section 50570-1 (50570-1)

Do not use - If rashes appear on skin.

Section 51727-6 (51727-6)

Inactive Ingredients:

Petrolatum, Carthamus Tinctorius (Safflower) Seed Oil, Tocopheryl Acetate, Zinc Oxide , Titanium Dioxide, Caprylic/Capric Triglyceride, Glyceryl Isostearate, Polyhydroxystearic Acid , Glycosaminoglycans, Dimethicone, Triethoxycaprylylsilane, PEG-8 , Tocopherol , Ascorbyl Palmitate , Ascorbic Acid, Citric Acid

Section 51945-4 (51945-4)

Manufactured for DermaQuest®, Inc.

Hayward, CA 94544

1272 GK, NL Made in USA

dermaquestinc.com

Section 55105-1 (55105-1)

Purpose: Anti-itch

Section 55106-9 (55106-9)

Active Ingredient: Hydrocortisone 1%

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:40.166530 · Updated: 2026-03-14T23:05:33.999008