Drug Facts

Drug Facts

SPL v3

SPL

SPL Set ID e2df8130-e7c8-4fde-a6d6-c71378991213

Route

TOPICAL

Published

Effective Date 2023-10-13

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Hydrocortisone (0.01 g)

Inactive Ingredients

Propylene Glycol White Petrolatum Mineral Oil Cetostearyl Alcohol Polyoxyl 20 Cetostearyl Ether Chlorocresol Water

Identifiers & Packaging

Pill Appearance

Color: white

Marketing Status

OTC MONOGRAPH DRUG Active Since 2024-01-01

Description

Hydrocortisone 1%

Purpose

Anti-Itch

Medication Information

Purpose

Anti-Itch

Description

Hydrocortisone 1%

Uses

For the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to: eczema, psoriasis, poison ivy, oak & sumac, insect bites, detergents, jewelry, seborrheic dermatitis, and soap
Other uses of this product should be only under the advice and supervision of a doctor

Section 51727-6

Ceteareth 20, Cetostearyl Alcohol, Chlorocresol, Mineral Oil, Propylene Glycol, Purified Water, White Petrolatum

Section 51945-4

Warnings

For external use only

Do not use: For the treatment of diaper rash. Consult a doctor

When using this product:

Avoid contact with the eyes

Do not begin use of any other hydrocortisone product unless you have consulted a doctor

Stop use and ask a doctor if:

Condition worsens

Symptoms persist for more than 7 days or clear up and occur again within a few days

Directions

Adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily.
Children under 2 years of age do not use. Ask a doctor.

Active Ingredient

Hydrocortisone 1%

Keep Out of Reach of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

Structured Label Content

Uses

For the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to: eczema, psoriasis, poison ivy, oak & sumac, insect bites, detergents, jewelry, seborrheic dermatitis, and soap
Other uses of this product should be only under the advice and supervision of a doctor

Section 51727-6 (51727-6)

Ceteareth 20, Cetostearyl Alcohol, Chlorocresol, Mineral Oil, Propylene Glycol, Purified Water, White Petrolatum

Section 51945-4 (51945-4)

Purpose

Anti-Itch

Warnings

For external use only

Do not use: For the treatment of diaper rash. Consult a doctor

When using this product:

Avoid contact with the eyes

Do not begin use of any other hydrocortisone product unless you have consulted a doctor

Stop use and ask a doctor if:

Condition worsens

Symptoms persist for more than 7 days or clear up and occur again within a few days

Directions

Adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily.
Children under 2 years of age do not use. Ask a doctor.

Active Ingredient

Hydrocortisone 1%

Keep Out of Reach of Children (Keep out of reach of Children)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

Advanced Ingredient Data

[{"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WHITE PETROLATUM", "unii": "B6E5W8RQJ4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MINERAL OIL", "unii": "T5L8T28FGP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CETOSTEARYL ALCOHOL", "unii": "2DMT128M1S", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYOXYL 20 CETOSTEARYL ETHER", "unii": "YRC528SWUY", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CHLOROCRESOL", "unii": "36W53O7109", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYDROCORTISONE", "unii": "WI4X0X7BPJ", "classCode": "ACTIB", "strengthNumerator": "0.01", "strengthDenominator": "1", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}]

Raw Label Data

All Sections (JSON)

{"Uses": "For the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to: eczema, psoriasis, poison ivy, oak & sumac, insect bites, detergents, jewelry, seborrheic dermatitis, and soap Other uses of this product should be only under the advice and supervision of a doctor", "51727-6": "Ceteareth 20, Cetostearyl Alcohol, Chlorocresol, Mineral Oil, Propylene Glycol, Purified Water, White Petrolatum", "Purpose": "Anti-Itch", "Warnings": "For external use only Do not use: For the treatment of diaper rash. Consult a doctor When using this product: Avoid contact with the eyes Do not begin use of any other hydrocortisone product unless you have consulted a doctor Stop use and ask a doctor if: Condition worsens Symptoms persist for more than 7 days or clear up and occur again within a few days", "Directions": "Adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily. Children under 2 years of age do not use. Ask a doctor.", "Active Ingredient": "Hydrocortisone 1%", "Keep out of reach of Children": "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:07:25.089183 · Updated: 2026-03-14T23:10:50.302579