Hydrocortisone

Hydrocortisone
SPL v1
SPL
SPL Set ID 26bc238d-3bda-0c29-e063-6394a90a35fb
Route
TOPICAL
Published
Effective Date 2024-11-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrocortisone (10 mg)
Inactive Ingredients
Aloe Vera Leaf Propylene Glycol Water Glyceryl Stearate Se Methylchloroisothiazolinone Stearic Acid White Petrolatum Cetostearyl Alcohol Trolamine

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-11-12
Description

Purpose Hydrocortisone USP 1% ............................................................................................................................................................................................................................................ Antipruritic (Anti-Itch) Uses For temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, psoriasis and for external genital, feminine, and anal itching

Medication Information

Warnings and Precautions

For External Use Only

If pregnant or breast-feeding, ask a health professional before use

Do not use In the eyes For diaper rash For external genital or feminine itching if you have a vaginal discharge More than the recommended

daily dosage unless directed by a doctor This product in the rectum by using fingers or any mechanical device or applicator

Ask a doctor before use if you are using any other hydrocortisone product

Stop use and ask a doctor if Condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days (do not

continue to use this or any other hydrocortisone product for longer than 7 days) Bleeding occurs due to anal itching

Indications and Usage

For temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, psoriasis and for external genital, feminine, and anal itching

Dosage and Administration

Purpose

Hydrocortisone USP 1% ............................................................................................................................................................................................................................................ Antipruritic (Anti-Itch)

Uses

For temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to eczema, insect bites, poison ivy, poison oak,

poison sumac, soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, psoriasis and for external genital, feminine, and anal itching

Description

Purpose Hydrocortisone USP 1% ............................................................................................................................................................................................................................................ Antipruritic (Anti-Itch) Uses For temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, psoriasis and for external genital, feminine, and anal itching

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

nactive Ingredients Aloe Vera, Cetostearyl Alcohol, Glyceryl Monostearate SE, Methylchloroisothiazolinone, Propylene Glycol, Purified Water, Stearic Acid, Trolamine, White Petrolatum

Section 51945-4

Section 55105-1

antipruritic (Anti-Itch

Structured Label Content

Indications and Usage (34067-9)

For temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, psoriasis and for external genital, feminine, and anal itching

Dosage and Administration (34068-7)

Purpose

Hydrocortisone USP 1% ............................................................................................................................................................................................................................................ Antipruritic (Anti-Itch)

Uses

For temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to eczema, insect bites, poison ivy, poison oak,

poison sumac, soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, psoriasis and for external genital, feminine, and anal itching

Warnings and Precautions (34071-1)

For External Use Only

If pregnant or breast-feeding, ask a health professional before use

Do not use In the eyes For diaper rash For external genital or feminine itching if you have a vaginal discharge More than the recommended

daily dosage unless directed by a doctor This product in the rectum by using fingers or any mechanical device or applicator

Ask a doctor before use if you are using any other hydrocortisone product

Stop use and ask a doctor if Condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days (do not

continue to use this or any other hydrocortisone product for longer than 7 days) Bleeding occurs due to anal itching

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)

nactive Ingredients Aloe Vera, Cetostearyl Alcohol, Glyceryl Monostearate SE, Methylchloroisothiazolinone, Propylene Glycol, Purified Water, Stearic Acid, Trolamine, White Petrolatum

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

antipruritic (Anti-Itch

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:23.930972 · Updated: 2026-03-14T23:05:05.669082