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SPL v1

SPL

SPL Set ID 4924ca59-7295-50af-e063-6394a90a5ed3

Route

CUTANEOUS

Published

Effective Date 2026-01-25

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Hydrocortisone (1 g)

Inactive Ingredients

Methoxy Peg-22/dodecyl Glycol Copolymer Stearyl Alcohol Glyceryl Monostearate Water

Identifiers & Packaging

Marketing Status

UNAPPROVED HOMEOPATHIC Active Since 2026-01-24

Description

Hydrocortisone

Medication Information

Warnings and Precautions

keep out of reach of children section

Indications and Usage

Anti-inflammatory

Dosage and Administration

Apply to the affected area

Description

Hydrocortisone

Section 50565-1

keep out of reach of children section

Section 51727-6

Glyceryl Monostearate,Stearyl Alcohol,Water,Vaseline

Section 51945-4

Section 55105-1

Anti-inflammatory

Section 55106-9

Hydrocortisone

Structured Label Content

Indications and Usage (34067-9)

Anti-inflammatory

Dosage and Administration (34068-7)

Apply to the affected area

Warnings and Precautions (34071-1)

keep out of reach of children section

Section 50565-1 (50565-1)

keep out of reach of children section

Section 51727-6 (51727-6)

Glyceryl Monostearate,Stearyl Alcohol,Water,Vaseline

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Anti-inflammatory

Section 55106-9 (55106-9)

Hydrocortisone

Advanced Ingredient Data

[{"name": "METHOXY PEG-22/DODECYL GLYCOL COPOLYMER", "unii": "2T6YOF5WQT", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYDROCORTISONE", "unii": "WI4X0X7BPJ", "classCode": "ACTIB", "strengthNumerator": "1", "strengthDenominator": "1", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "1"}, {"name": "STEARYL ALCOHOL", "unii": "2KR89I4H1Y", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERYL MONOSTEARATE", "unii": "230OU9XXE4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Anti-inflammatory", "34068-7": "Apply to the affected area", "34071-1": "keep out of reach of children section", "50565-1": "keep out of reach of children section", "51727-6": "Glyceryl Monostearate,Stearyl Alcohol,Water,Vaseline", "55105-1": "Anti-inflammatory", "55106-9": "Hydrocortisone"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:12:12.556426 · Updated: 2026-03-14T23:17:37.584721