drug facts

drug facts
SPL v1
SPL
SPL Set ID c04e0cee-2e3b-4e14-9d98-53090d81eec5
Route
topical
Published
Effective Date 2010-08-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
hydrocortisone (10 mg)

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2010-01-01
Description

ACTIVE INGREDIENT: Hydrocortisone 1%

Medication Information

Warnings and Precautions

WARNINGS:

For external use only.

Ask a doctor if bleeding occurs or conditions worsens



Active Ingredient

ACTIVE INGREDIENT:

Hydrocortisone 1%

Indications and Usage

USES:

  • promotes healing of itchy skin
  • keeps skin hydrated



Dosage and Administration

DIRECTIONS:

Apply to the skin as instructed by your skincare professional to keep the skin hydrated and to promote healing.

Description

ACTIVE INGREDIENT: Hydrocortisone 1%

Section 50565-1

Keep out of reach of chilren.

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

Section 51727-6

INACTIVE INGREDIENTS:

Petrolatum, Tocopheryl Acetate (Vitamin E), Carthamus Tinctorius (Safflower) Seed Oil, Ubiquinone (Co-Enzyme Q10), Zinc Oxide (Cl 77947), Titanium Dioxide (Cl 77891), Ascorbyl Palmiate (Vitamin C), Glycosaminoglycans.

Section 51945-4

DISTRIBUTOR:

DermaQuest, Inc.

Hayward, CA

dermaquestinc.com



IMAGE OF PRINCIPAL DISPLAY PANEL:





Section 55105-1

PURPOSE:

Anti-itch

Structured Label Content

Warnings and Precautions (34071-1)

WARNINGS:

For external use only.

Ask a doctor if bleeding occurs or conditions worsens



Active Ingredient (55106-9)

ACTIVE INGREDIENT:

Hydrocortisone 1%

Indications and Usage (34067-9)

USES:

  • promotes healing of itchy skin
  • keeps skin hydrated



Dosage and Administration (34068-7)

DIRECTIONS:

Apply to the skin as instructed by your skincare professional to keep the skin hydrated and to promote healing.

Section 50565-1 (50565-1)

Keep out of reach of chilren.

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

Section 51727-6 (51727-6)

INACTIVE INGREDIENTS:

Petrolatum, Tocopheryl Acetate (Vitamin E), Carthamus Tinctorius (Safflower) Seed Oil, Ubiquinone (Co-Enzyme Q10), Zinc Oxide (Cl 77947), Titanium Dioxide (Cl 77891), Ascorbyl Palmiate (Vitamin C), Glycosaminoglycans.

Section 51945-4 (51945-4)

DISTRIBUTOR:

DermaQuest, Inc.

Hayward, CA

dermaquestinc.com



IMAGE OF PRINCIPAL DISPLAY PANEL:





Section 55105-1 (55105-1)

PURPOSE:

Anti-itch

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:07.155412 · Updated: 2026-03-14T22:52:27.184723