Hydrocortisone Ointment Maximum Strength - Actavis

Hydrocortisone Ointment Maximum Strength - Actavis
SPL v14
SPL
SPL Set ID 21587275-aa63-43bb-a88d-2750d6213d68
Route
TOPICAL
Published
Effective Date 2020-06-01
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 NOT FINAL Active Since 1998-07-21

Description

Hydrocortisone, USP 1%

Purpose

Anti-itch

How Supplied

Product: 50090-0238 NDC: 50090-0238-0 28 g in a TUBE / 1 in a CARTON


Medication Information

Purpose

Anti-itch

How Supplied

Product: 50090-0238

NDC: 50090-0238-0 28 g in a TUBE / 1 in a CARTON

Description

Hydrocortisone, USP 1%

Uses

for the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to:

  • eczema
  • insect bites
  • poison ivy
  • poison oak
  • poison sumac
  • soaps
  • jewelry
  • detergents
  • cosmetics
  • psoriasis
  • seborrheic dermatitis
  • for external genital, feminine and anal itching
  • other uses of this product should be only under the advice and supervision of a doctor
Warnings

For external use only

Directions

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

  • do not use, consult a doctor

For external anal 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 

Children under 12 years of age: consult a doctor

Do Not Use
  • for external feminine itching if you have a vaginal discharge. Consult a doctor.
  • for the treatment of diaper rash. Consult a doctor.
Drug Facts



Questions?

1-800-432-8534 between 9 am and 4 pm EST, Monday–Friday.

Hydrocortisone
Active Ingredient

Hydrocortisone, USP 1%

Other Information
  • Store at room temperature 59°-86°F (15°-30°C).
  • Before using any medication, read all label directions. Keep carton, it contains important information.
Inactive Ingredients

mineral oil, white petrolatum

When Using This Product
  • avoid contact with the eyes

  • do not begin the use of any other hydrocortisone product unless directed by a doctor

  • for external anal itching:

  • do not use more than directed unless directed by a doctor

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

Stop Use and Ask A Doctor If
  • symptoms last for more than 7 days
  • the condition gets worse
  • symptoms clear up and occur again in a few days
  • rectal bleeding occurs, consult doctor promptly
Keep Out of Reach of Children.

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


Structured Label Content

Uses

for the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to:

  • eczema
  • insect bites
  • poison ivy
  • poison oak
  • poison sumac
  • soaps
  • jewelry
  • detergents
  • cosmetics
  • psoriasis
  • seborrheic dermatitis
  • for external genital, feminine and anal itching
  • other uses of this product should be only under the advice and supervision of a doctor
Purpose

Anti-itch

Warnings

For external use only

Directions

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

  • do not use, consult a doctor

For external anal 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 

Children under 12 years of age: consult a doctor

Do Not Use (Do not use)
  • for external feminine itching if you have a vaginal discharge. Consult a doctor.
  • for the treatment of diaper rash. Consult a doctor.
Drug Facts



Questions?

1-800-432-8534 between 9 am and 4 pm EST, Monday–Friday.

How Supplied (HOW SUPPLIED)

Product: 50090-0238

NDC: 50090-0238-0 28 g in a TUBE / 1 in a CARTON

Hydrocortisone
Active Ingredient (Active ingredient)

Hydrocortisone, USP 1%

Other Information (Other information)
  • Store at room temperature 59°-86°F (15°-30°C).
  • Before using any medication, read all label directions. Keep carton, it contains important information.
Inactive Ingredients (Inactive ingredients)

mineral oil, white petrolatum

When Using This Product (When using this product)
  • avoid contact with the eyes

  • do not begin the use of any other hydrocortisone product unless directed by a doctor

  • for external anal itching:

  • do not use more than directed unless directed by a doctor

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

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • symptoms last for more than 7 days
  • the condition gets worse
  • symptoms clear up and occur again in a few days
  • rectal bleeding occurs, consult doctor promptly
Keep Out of Reach of Children. (Keep out of reach of children.)

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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)