Hydrocortisone 1% Cream

SPL v5

SPL

SPL Set ID cb6e0bed-2ea1-49d2-89e7-2554e7565b74

Route

TOPICAL

Published

Effective Date 2022-02-02

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Hydrocortisone (1 g)

Inactive Ingredients

Sodium Lauryl Sulfate Water Cetostearyl Alcohol Petrolatum Propylene Glycol

Identifiers & Packaging

Pill Appearance

Color: white

Marketing Status

OTC MONOGRAPH DRUG Active Since 2022-01-28

Description

Drug Facts

Purpose

Anti-itch cream

Medication Information

Purpose

Anti-itch cream

Description

Drug Facts

Uses

temporary relief of itching associated with minor skin irritations and rashes due to
- eczema
- insect bites
- poison ivy, poison oak, or poison sumac
- soaps
- detergents
- cosmetics
- jewelry
- seborrheic dermatitis
- psoriasis
- external genital and anal itching
other uses of this product should be only under the advice and supervision of a doctor

Section 42229-5

Drug Facts

Section 50565-1

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

Section 50567-7

When using this productconsult a doctor before exceeding recommended dosage

Warnings

For external use only

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. Consult a doctor

Do Not Use

in the eyes
by putting this product into the rectum by using fingers or any mechanical device or applicator

Questions?

Call 1-866-923-4914

Active Ingredient

Hydrocortisone acetate (equivalent to Hydrocortisone 1%)

Other Information

store at room temperature
see carton or tube crimp for lot number and expiration date

Inactive Ingredients

cetostearyl alcohol, propylene glycol, purified water, sodium lauryl sulfate, white petrolatum

Stop Use and Ask A Doctor If

condition gets worse
condition persists for more than 7 days
condition clears up and occurs again within a few days.

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

Ask A Doctor Before Use If You Have

a vaginal discharge
rectal bleeding
diaper rash

Principal Display Panel 28.4 G Tube Carton

MAXIMUM STRENGTH

HYDROCORTISONE 1% CREAM

HYDROCORTISONE ACETATE

ANTI-ITCH

HYPOALLERGENIC

ITCH AND RASH

RELIEF

NET WT 1 OZ (28.4 g)

Structured Label Content

Uses

temporary relief of itching associated with minor skin irritations and rashes due to
- eczema
- insect bites
- poison ivy, poison oak, or poison sumac
- soaps
- detergents
- cosmetics
- jewelry
- seborrheic dermatitis
- psoriasis
- external genital and anal itching
other uses of this product should be only under the advice and supervision of a doctor

Section 42229-5 (42229-5)

Drug Facts

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 50567-7 (50567-7)

When using this productconsult a doctor before exceeding recommended dosage

Purpose

Anti-itch cream

Warnings

For external use only

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. Consult a doctor

Do Not Use (Do not use)

in the eyes
by putting this product into the rectum by using fingers or any mechanical device or applicator

Questions?

Call 1-866-923-4914

Active Ingredient (Active ingredient)

Hydrocortisone acetate (equivalent to Hydrocortisone 1%)

Other Information (Other information)

store at room temperature
see carton or tube crimp for lot number and expiration date

Inactive Ingredients (Inactive ingredients)

cetostearyl alcohol, propylene glycol, purified water, sodium lauryl sulfate, white petrolatum

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

condition gets worse
condition persists for more than 7 days
condition clears up and occurs again within a few days.

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

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

a vaginal discharge
rectal bleeding
diaper rash

Principal Display Panel 28.4 G Tube Carton (PRINCIPAL DISPLAY PANEL - 28.4 g Tube Carton)

MAXIMUM STRENGTH

HYDROCORTISONE 1% CREAM

HYDROCORTISONE ACETATE

ANTI-ITCH

HYPOALLERGENIC

ITCH AND RASH

RELIEF

NET WT 1 OZ (28.4 g)

Advanced Ingredient Data

[{"name": "SODIUM LAURYL SULFATE", "unii": "368GB5141J", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CETOSTEARYL ALCOHOL", "unii": "2DMT128M1S", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PETROLATUM", "unii": "4T6H12BN9U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "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)

{"Uses": "temporary relief of itching associated with minor skin irritations and rashes due to eczema insect bites poison ivy, poison oak, or poison sumac soaps detergents cosmetics jewelry seborrheic dermatitis psoriasis external genital and anal itching other uses of this product should be only under the advice and supervision of a doctor", "42229-5": "Drug Facts", "50565-1": "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.", "50567-7": "When using this product consult a doctor before exceeding recommended dosage", "Purpose": "Anti-itch cream", "Warnings": "For external use only", "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. Consult a doctor", "Do not use": "in the eyes by putting this product into the rectum by using fingers or any mechanical device or applicator", "Questions?": "Call 1-866-923-4914", "Active ingredient": "Hydrocortisone acetate (equivalent to Hydrocortisone 1%)", "Other information": "store at room temperature see carton or tube crimp for lot number and expiration date", "Inactive ingredients": "cetostearyl alcohol, propylene glycol, purified water, sodium lauryl sulfate, white petrolatum", "Stop use and ask a doctor if": "condition gets worse condition persists for more than 7 days condition clears up and occurs again within a few days. Do not begin to use any other hydrocortisone product unless you have consulted a doctor.", "Ask a doctor before use if you have": "a vaginal discharge rectal bleeding diaper rash", "PRINCIPAL DISPLAY PANEL - 28.4 g Tube Carton": "MAXIMUM STRENGTH HYDROCORTISONE 1% CREAM HYDROCORTISONE ACETATE ANTI-ITCH HYPOALLERGENIC ITCH AND RASH RELIEF NET WT 1 OZ (28.4 g)"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:29.880393 · Updated: 2026-03-14T23:09:18.179019