43473-092 Health And Beyond Hydrocortison Cream

SPL v2

SPL

SPL Set ID bdcd5b01-f5e2-4519-bf4d-25e3cc7e67af

Route

TOPICAL

Published

Effective Date 2025-11-22

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Hydrocortisone (1 g)

Inactive Ingredients

Glycerin Polyoxyl 20 Cetostearyl Ether Cetostearyl Alcohol Ethylhexylglycerin Water Mineral Oil Petrolatum Phenoxyethanol Glyceryl Stearate Se

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2025-11-22

Description

Active ingredient Hydrocortisone 1%

Medication Information

Warnings and Precautions

Warnings

For external use only.

Do not use

for the treatment of diaper rash. Consult a doctor

Indications and Usage

Uses

for temorary relief of itching associated with minor irritations and rashes
other uses of this product should be only under the advice and supervision of a doctor

Dosage and Administration

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

Description

Active ingredient Hydrocortisone 1%

Section 44425-7

Stop use and ask a doctor

if condition worsens, or if symptoms persist for more than 7 days, or clears up and occurs again within a few days
with use of any other hydrocortisone products

Section 50565-1

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

Section 51727-6

Inactive ingredients

cetearyl alcohol, ceteareth-20, ethylhexylglycerin, glycerin, glyceryl stearate, mineral oil, petrolactum, phenoxyethanol, water

Section 51945-4

Section 55105-1

Purpose Anti-itch

Section 55106-9

Active ingredient

Hydrocortisone 1%

Structured Label Content

Indications and Usage (34067-9)

Uses

for temorary relief of itching associated with minor irritations and rashes
other uses of this product should be only under the advice and supervision of a doctor

Dosage and Administration (34068-7)

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

Warnings and Precautions (34071-1)

Warnings

For external use only.

Do not use

for the treatment of diaper rash. Consult a doctor

Section 44425-7 (44425-7)

Stop use and ask a doctor

if condition worsens, or if symptoms persist for more than 7 days, or clears up and occurs again within a few days
with use of any other hydrocortisone products

Section 50565-1 (50565-1)

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

Section 51727-6 (51727-6)

Inactive ingredients

cetearyl alcohol, ceteareth-20, ethylhexylglycerin, glycerin, glyceryl stearate, mineral oil, petrolactum, phenoxyethanol, water

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose Anti-itch

Section 55106-9 (55106-9)

Active ingredient

Hydrocortisone 1%

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"34067-9": "Uses for temorary relief of itching associated with minor irritations and rashes other uses of this product should be only under the advice and supervision of a doctor", "34068-7": "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", "34071-1": "Warnings For external use only . Do not use for the treatment of diaper rash. Consult a doctor", "44425-7": "Stop use and ask a doctor if condition worsens, or if symptoms persist for more than 7 days, or clears up and occurs again within a few days with use of any other hydrocortisone products", "50565-1": "Keep out of reach of children . If swallowed, get medical help or contact a Poison Control Center right away.", "51727-6": "Inactive ingredients cetearyl alcohol, ceteareth-20, ethylhexylglycerin, glycerin, glyceryl stearate, mineral oil, petrolactum, phenoxyethanol, water", "55105-1": "Purpose Anti-itch", "55106-9": "Active ingredient Hydrocortisone 1%"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:20.438281 · Updated: 2026-03-14T23:10:41.056891