SPL v1
SPL
SPL Set ID 197fc623-2fb9-184c-e063-6394a90a4104
Route
TOPICAL
Published
Effective Date 2024-06-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrocortisone (1 g)
Inactive Ingredients
Mineral Oil Petrolatum Ethylhexylglycerin Glycerin Phenoxyethanol Water

Identifiers & Packaging

Pill Appearance
Size: 35 mm
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-05-28

Medication Information

Warnings and Precautions

Indications and Usage

Dosage and Administration

Section 50565-1

Section 51727-6

Section 51945-4

Section 55105-1

Structured Label Content

Indications and Usage (34067-9)

Dosage and Administration (34068-7)

Warnings and Precautions (34071-1)

Section 50565-1 (50565-1)

Section 51727-6 (51727-6)

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:08.634716 · Updated: 2026-03-14T23:03:02.507799