Hydrocortisone Ointment 1% Antipruritic (anti-itch)

Hydrocortisone Ointment 1% Antipruritic (anti-itch)
SPL v9
SPL
SPL Set ID 9a23c992-2df9-4bef-9409-47805eecfacd
Route
TOPICAL
Published
Effective Date 2016-04-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2016-04-09

Description

Hydrocortisone 1%

Purpose

Anti-Itch


Medication Information

Purpose

Anti-Itch

Description

Hydrocortisone 1%

Uses

temporary relieves itching associated with minor skin irritations, inflammation and rashes due to:

● eczema        ● seborrheic dermatitis    ● psoriasis   ● insect bites   ● poison ivy, oak, sumac   ● soaps

● detergents    ● cosmetics                     ● jewelry     ● external genital and anal itching

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

Section 42229-5

MAXIMUM STRENGTH

Distributed by:

Trifecta Pharmaceuticals USA™

101 NE Third Avenue, Suite 1500

Ft. Lauderdale, FL 33301 USA

Product of PRC



www.trifecta-pharma.com

Warnings

● for external use only ● avoid contact with the eyes

do not put this product into the rectum by using fingers or any mechanical device or applicator

Stop using this product and ask a doctor ● in case of bleeding

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

● before you begin using any other hydrocortisone product

Do not use this product and ask a doctor

● if you have a vaginal discharge ● before treating diaper rash ● before using on children under 2 years of age

For External Anal Itching Users: ● do not exceed the recommended daily dosage unless directed by a doctor

● in case of bleeding, consult a doctor promptly

● do not put this product into the rectum by using fingers or any mechanical device or applicator

● children under 12 years of age: consult a doctor



Before using any medication, read all label directions. Keep this carton. It contains important information.

Packaging

Drug Facts

Directions

● when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly.

● gently dry by patting or blotting with toilet tissue or a soft cloth before applying.

● adults and children 12 years of age and older: apply to the affected area not more than 3 to 4 times daily.

● children under 12 years of age: Do not use, consult a doctor.

Active Ingredient

Hydrocortisone 1%

Other Information

● to open: unscrew cap and pull tab to remove foil seal

● if seal has been broken, do not use this product. Return product to the Store where you bought it

● store at controlled room temperature 15°-30°C ( 59 °- 86 °F)



see carton or tube crimp for lot number and expiration date

Inactive Ingredients

Light Mineral Oil, Petrolatum

Keep Out of the Reach of Children.

If swallowed, get medical help or contact a Poison Control Center immediately.


Structured Label Content

Uses

temporary relieves itching associated with minor skin irritations, inflammation and rashes due to:

● eczema        ● seborrheic dermatitis    ● psoriasis   ● insect bites   ● poison ivy, oak, sumac   ● soaps

● detergents    ● cosmetics                     ● jewelry     ● 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)

MAXIMUM STRENGTH

Distributed by:

Trifecta Pharmaceuticals USA™

101 NE Third Avenue, Suite 1500

Ft. Lauderdale, FL 33301 USA

Product of PRC



www.trifecta-pharma.com

Purpose

Anti-Itch

Warnings

● for external use only ● avoid contact with the eyes

do not put this product into the rectum by using fingers or any mechanical device or applicator

Stop using this product and ask a doctor ● in case of bleeding

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

● before you begin using any other hydrocortisone product

Do not use this product and ask a doctor

● if you have a vaginal discharge ● before treating diaper rash ● before using on children under 2 years of age

For External Anal Itching Users: ● do not exceed the recommended daily dosage unless directed by a doctor

● in case of bleeding, consult a doctor promptly

● do not put this product into the rectum by using fingers or any mechanical device or applicator

● children under 12 years of age: consult a doctor



Before using any medication, read all label directions. Keep this carton. It contains important information.

Packaging

Drug Facts (DRUG FACTS)

Directions

● when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly.

● gently dry by patting or blotting with toilet tissue or a soft cloth before applying.

● adults and children 12 years of age and older: apply to the affected area not more than 3 to 4 times daily.

● children under 12 years of age: Do not use, consult a doctor.

Active Ingredient (Active ingredient)

Hydrocortisone 1%

Other Information (Other information)

● to open: unscrew cap and pull tab to remove foil seal

● if seal has been broken, do not use this product. Return product to the Store where you bought it

● store at controlled room temperature 15°-30°C ( 59 °- 86 °F)



see carton or tube crimp for lot number and expiration date

Inactive Ingredients (Inactive ingredients)

Light Mineral Oil, Petrolatum

Keep Out of the Reach of Children. (Keep out of the reach of children.)

If swallowed, get medical help or contact a Poison Control Center immediately.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)