81552-003 Hydrocortisone Cream

SPL v2

SPL

SPL Set ID e8154890-eb2f-42c1-a594-9f2a40424b04

Route

TOPICAL

Published

Effective Date 2021-04-20

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Hydrocortisone (1 g)

Inactive Ingredients

Petrolatum Paraffin Octadecanol (mixture Of Isomers) Water Stearic Acid Glycerol Formal

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2021-04-20

Description

Hydrocortisone 1%

Purpose

Anti-Itch

Medication Information

Purpose

Anti-Itch

Description

Hydrocortisone 1%

Use

Temporary relieves itching associated with minor irritations and rashes

Other uses should be only under the advice and supervision of a doctor

Section 50565-1

Keep out of reach of children. If ingested, get medical help or contact a poison control center right away

Section 50566-9

Stop use and ask a doctor if

Condition worsens or persists for more than 7 days

Symptoms clear up and occur within a few days

Section 50567-7

When using this product

Do not use any other hydrocortisone products unless you have contacted a doctor

Section 50570-1

Do not use

In or near eyes
For diaper rash, consult a doctor

Section 51945-4

Warnings

For external use only

Directions

Adults and children two years of age and older: Apply to affected area not more than 3-4 timesdaily

Children under 2 years of age: Do not use

Active Ingredient

Hydrocortisone 1%

Other Information

Store at room temperature

Inactive Ingredients

Petrolactum, Liquid Paraffin, Octadecanol, Glycerol, Stearic Acid, Purified Water

Structured Label Content

Use

Temporary relieves itching associated with minor irritations and rashes

Other uses should be only under the advice and supervision of a doctor

Section 50565-1 (50565-1)

Keep out of reach of children. If ingested, get medical help or contact a poison control center right away

Section 50566-9 (50566-9)

Stop use and ask a doctor if

Condition worsens or persists for more than 7 days

Symptoms clear up and occur within a few days

Section 50567-7 (50567-7)

When using this product

Do not use any other hydrocortisone products unless you have contacted a doctor

Section 50570-1 (50570-1)

Do not use

In or near eyes
For diaper rash, consult a doctor

Section 51945-4 (51945-4)

Purpose

Anti-Itch

Warnings (WARNINGS)

For external use only

Directions

Adults and children two years of age and older: Apply to affected area not more than 3-4 timesdaily

Children under 2 years of age: Do not use

Active Ingredient

Hydrocortisone 1%

Other Information

Store at room temperature

Inactive Ingredients (Inactive ingredients)

Petrolactum, Liquid Paraffin, Octadecanol, Glycerol, Stearic Acid, Purified Water

Advanced Ingredient Data

[{"name": "PETROLATUM", "unii": "4T6H12BN9U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PARAFFIN", "unii": "I9O0E3H2ZE", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "OCTADECANOL (MIXTURE OF ISOMERS)", "unii": "C6BPY2QY39", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STEARIC ACID", "unii": "4ELV7Z65AP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCEROL FORMAL", "unii": "3L7GR2604E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYDROCORTISONE", "unii": "WI4X0X7BPJ", "classCode": "ACTIB", "strengthNumerator": "1", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}]

Raw Label Data

All Sections (JSON)

{"Use": " Temporary relieves itching associated with minor irritations and rashes Other uses should be only under the advice and supervision of a doctor", "50565-1": "Keep out of reach of children. If ingested, get medical help or contact a poison control center right away", "50566-9": "Stop use and ask a doctor if Condition worsens or persists for more than 7 days Symptoms clear up and occur within a few days", "50567-7": "When using this product Do not use any other hydrocortisone products unless you have contacted a doctor", "50570-1": "Do not use In or near eyes For diaper rash, consult a doctor", "Purpose": "Anti-Itch", "WARNINGS": "For external use only", "Directions": "Adults and children two years of age and older: Apply to affected area not more than 3-4 timesdaily Children under 2 years of age: Do not use", "Active Ingredient": "Hydrocortisone 1%", "Other Information": "Store at room temperature", "Inactive ingredients": "Petrolactum, Liquid Paraffin, Octadecanol, Glycerol, Stearic Acid, Purified Water"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:59:52.855318 · Updated: 2026-03-14T23:00:02.948947