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

Purpose

Anti-Itch

Description

Hydrocortisone 1%


Medication Information

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.

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

Purpose

Anti-Itch

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.

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

Description

Hydrocortisone 1%

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

Packaging

Drug Facts

Active Ingredient

Hydrocortisone 1%

Keep Out of the Reach of Children.

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


Structured Label Content

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.

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

Purpose

Anti-Itch

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.

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

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

Packaging

Drug Facts (DRUG FACTS)

Active Ingredient (Active ingredient)

Hydrocortisone 1%

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

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