SPL v1
SPL
SPL Set ID 39fae2a4-902e-3c88-e063-6394a90acbd5
Route
TOPICAL
Published
Effective Date 2025-07-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrocortisone (1 g)
Inactive Ingredients
Methylparaben Petrolatum Edetate Disodium Propylene Glycol Mineral Oil Sorbitan Monostearate Polysorbate 60 Propylparaben Water

Identifiers & Packaging

Pill Appearance
Size: 105 mm
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-07-16

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: 2026-02-15T12:06:31.665205 · Updated: 2026-03-14T23:09:21.323328