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

Purpose

Anti-itch

Description

Hydrocortisone USP, 1%


Medication Information

Warnings

For external use only.

Purpose

Anti-itch

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

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.

Inactive Ingredients

mineral oil, white petrolatum

Description

Hydrocortisone USP, 1%

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)









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



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.

Active Ingredient(s)

Hydrocortisone USP, 1%

Questions Or Comments?

Call 1-833-285-4151

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

Warnings (WARNINGS)

For external use only.

Purpose (PURPOSE)

Anti-itch

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

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.

Inactive Ingredients (INACTIVE INGREDIENTS)

mineral oil, white petrolatum

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)









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



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.

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

Hydrocortisone USP, 1%

Questions Or Comments? (QUESTIONS OR COMMENTS?)

Call 1-833-285-4151

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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