hydrocortisone ointment 1%

hydrocortisone ointment 1%
SPL v10
SPL
SPL Set ID 2999fecb-cb15-4023-ade4-ab5822b094d5
Route
topical
Published
Effective Date 2015-03-28
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

Pill Appearance
Color: white
Marketing Status
otc monograph drug active Since 2015-03-10

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 for lot number and expiration date.

Description

Hydrocortisone 1%

Section 42229-5

Distributed by:

Trifecta Pharmaceuticals USA™

101 NE Third Avenue, Suite 1500

Ft. Lauderdale, FL 33301, USA

1-888-296-9067

Section 51727-6

Inactive ingredients Light Mineral Oil, White Petrolatum

Packaging

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
  • 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 for lot number and expiration date.

Section 42229-5 (42229-5)

Distributed by:

Trifecta Pharmaceuticals USA™

101 NE Third Avenue, Suite 1500

Ft. Lauderdale, FL 33301, USA

1-888-296-9067

Section 51727-6 (51727-6)

Inactive ingredients Light Mineral Oil, White Petrolatum

Packaging

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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