Hydrocortisone Cream Usp, 1%

Hydrocortisone Cream Usp, 1%
SPL v2
SPL
SPL Set ID 969cd576-82d3-4662-bbc1-3587a1f6a564
Route
TOPICAL
Published
Effective Date 2025-11-10
Document Type 34390-5 Human OTC Drug Label

Drug Facts

Composition & Product

Active Ingredients
Hydrocortisone (1 g)
Inactive Ingredients
Cetyl Alcohol Citric Acid Monohydrate Glyceryl Monostearate Isopropyl Myristate Methylparaben Polyoxyl 40 Stearate Polysorbate 60 Propylene Glycol Propylparaben Water Sodium Citrate Sorbic Acid Sorbitan Monostearate Stearyl Alcohol White Wax

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-02-25

Description

Hydrocortisone, USP 1%

Purpose

Anti-itch


Medication Information

Purpose

Anti-itch

Description

Hydrocortisone, USP 1%

Use(s)

■temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to 

     ■eczema ■ psoriasis ■ insect bites ■ poison ivy, oak, sumac

     ■detergents ■ jewelry ■ cosmetics ■ soaps ■ seborrheic dermatitis

■temporarily relieves external anal and genital itching

■other uses of this product should be only under the advice and supervision of a doctor

Warnings

For external use only.

Directions

■ for itching of skin irritation, inflammation, and rashes

  ■ 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: consult a doctor

■ for external anal and genital itching

  ■ adults: when practical, clean the affected area with mild soap and warm water; rinse thoroughly

  ■ gently dry by paling or blotting with toilet Issue or a soft cloth before application of this product

  ■ apply to affected area not more than 3 to 4 times daily 

  ■ children under 12 years of age: consult a doctor

Do Not Use

■ in the genital area if you have a vaginal discharge. Consult a doctor.

■ for the treatment o1 diaper rash. Consult a doctor.

Other Information

■ store at 15°C to 30°C (59°F to 86°F). Protect from freezing.

■ before using any medication, read all label directions. Keep carton, it contains important information.

Active Ingredient(s)

Hydrocortisone, USP 1%

Inactive Ingredients

cetyl alcohol, citric acid*, glyceryl stearate, isopropyl myristate, methylparaben, polyoxyl 40 stearate, polysorbate 60, propylene glycol, propylparaben, purified water, sodium citrate solution* sorbic acid, sorbitan monostearate, stearyl alcohol, white wax

*Contains one or more of these ingredients to adjust pH

Questions Or Comments?

Call 1-833-285-4151

Principal Display Panel

Hydrocortisone Cream USP, 1%

Anti-itch Cream

Net wt. 1 oz (28g)

Hydrocortisone Cream USP, 1%

Anti-itch Cream

Net wt. 0.5 oz (14g)

When Using This Product

■ avoid contact with the eyes

■ do not use more than directed unless directed by a doctor

■ do not put directly into the rectum by using fingers or any mechanical device or  isopropyl applicator

Stop Use and Ask Doctor If

■ condition worsens, symptoms persist for more than 7 days or clear up and occur again within a few days

■ do not begin the use of any other hydrocortisone product unless directed by a doctor

■ rectal bleeding occurs

Keep Out of Reach of Children

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.


Structured Label Content

Use(s) (USE(S))

■temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to 

     ■eczema ■ psoriasis ■ insect bites ■ poison ivy, oak, sumac

     ■detergents ■ jewelry ■ cosmetics ■ soaps ■ seborrheic dermatitis

■temporarily relieves external anal and genital itching

■other uses of this product should be only under the advice and supervision of a doctor

Purpose (PURPOSE)

Anti-itch

Warnings (WARNINGS)

For external use only.

Directions (DIRECTIONS)

■ for itching of skin irritation, inflammation, and rashes

  ■ 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: consult a doctor

■ for external anal and genital itching

  ■ adults: when practical, clean the affected area with mild soap and warm water; rinse thoroughly

  ■ gently dry by paling or blotting with toilet Issue or a soft cloth before application of this product

  ■ apply to affected area not more than 3 to 4 times daily 

  ■ children under 12 years of age: consult a doctor

Do Not Use (DO NOT USE)

■ in the genital area if you have a vaginal discharge. Consult a doctor.

■ for the treatment o1 diaper rash. Consult a doctor.

Other Information (OTHER INFORMATION)

■ store at 15°C to 30°C (59°F to 86°F). Protect from freezing.

■ before using any medication, read all label directions. Keep carton, it contains important information.

Active Ingredient(s) (ACTIVE INGREDIENT(S))

Hydrocortisone, USP 1%

Inactive Ingredients (INACTIVE INGREDIENTS)

cetyl alcohol, citric acid*, glyceryl stearate, isopropyl myristate, methylparaben, polyoxyl 40 stearate, polysorbate 60, propylene glycol, propylparaben, purified water, sodium citrate solution* sorbic acid, sorbitan monostearate, stearyl alcohol, white wax

*Contains one or more of these ingredients to adjust pH

Questions Or Comments? (QUESTIONS OR COMMENTS?)

Call 1-833-285-4151

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Hydrocortisone Cream USP, 1%

Anti-itch Cream

Net wt. 1 oz (28g)

Hydrocortisone Cream USP, 1%

Anti-itch Cream

Net wt. 0.5 oz (14g)

When Using This Product (WHEN USING THIS PRODUCT)

■ avoid contact with the eyes

■ do not use more than directed unless directed by a doctor

■ do not put directly into the rectum by using fingers or any mechanical device or  isopropyl applicator

Stop Use and Ask Doctor If (STOP USE AND ASK DOCTOR IF)

■ condition worsens, symptoms persist for more than 7 days or clear up and occur again within a few days

■ do not begin the use of any other hydrocortisone product unless directed by a doctor

■ rectal bleeding occurs

Keep Out of Reach of Children (KEEP OUT OF REACH OF CHILDREN)

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.


Advanced Ingredient Data


Raw Label Data

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