Hydrocortisone Ointment 1%

Hydrocortisone Ointment 1%
SPL v2
SPL
SPL Set ID d6f5c0df-6262-4704-bb24-430f66bb2ca8
Route
TOPICAL
Published
Effective Date 2025-03-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrocortisone (1 g)
Inactive Ingredients
Mineral Oil Petrolatum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-03-06

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 patting or blotting with toilet tissue 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 of 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

mineral oil, white petrolatum

Questions Or Comments?

Call 1-833-285-4151

Principal Display Panel

Hydrocortisone Ointment USP, 1%

Anti-itch ointment

Net wt. 0.5 oz (14g)





Hydrocortisone Ointment USP, 1%

Anti-itch ointment

Net wt. 1 oz (28g)









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 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 patting or blotting with toilet tissue 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 of 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)

mineral oil, white petrolatum

Questions Or Comments? (QUESTIONS OR COMMENTS?)

Call 1-833-285-4151

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Hydrocortisone Ointment USP, 1%

Anti-itch ointment

Net wt. 0.5 oz (14g)





Hydrocortisone Ointment USP, 1%

Anti-itch ointment

Net wt. 1 oz (28g)









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 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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