Hydrocortisone Ointment

Hydrocortisone Ointment
SPL v1
SPL
SPL Set ID 0c5325e3-4796-856c-e063-6394a90a1f90
Route
TOPICAL
Published
Effective Date 2023-10-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrocortisone (1 g)
Inactive Ingredients
White Petrolatum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-10-01

Description

Hydrocortisone 1%

Purpose

Anti-itch


Medication Information

Purpose

Anti-itch

Description

Hydrocortisone 1%

Uses

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

  • eczema
  • seborrheic dermatitis
  • poison ivy, poison oak, and poison sumac
  • psoriasis
  • insect bites
  • cosmetics
  • jewelry
  • detergents
  • soaps

temporarily relieves external anal and genital itching

other uses of this product should be only under the advise and supervision of a doctor

Section 51945-4

Warnings

For external use only

Directions

adults and children 2 years and over: apply to affected area not more than 3 to 4 times daily

children under 2 years: ask a doctor

for external anal itching in adults:

  • when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly, or by patting or blotting with an appropriate cleansing pad
  • gently dry by patting or blotting with toilet tissue or a soft cloth before applying

for external anal itching in children under 12 years: ask a doctor

Do Not Use
  • for the treatment of diaper rash. Ask a doctor.
  • for external genital itching if you have a vaginal discharge. Ask a doctor.
  • for external anal itching if rectal bleeding occurs. Consult a doctor promptly.
Active Ingredient

Hydrocortisone 1%

Other Information
  • store at 20ºC to 25ºC (68ºF to 77ºF)
Inactive Ingredient

white petrolatum

When Using This Product
  • do not get in the eyes
  • for external anal itching, do not use more than directed unless told to do so by a doctor
  • do not put into the rectum by using fingers or any mechanical device or applicator
Stop Use and Ask A Doctor If
  • condition gets worse, or if symptoms last for more than 7 days or clear up and occur again within a few days. Do not begin use of any other hydrocortisone product.
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
  • seborrheic dermatitis
  • poison ivy, poison oak, and poison sumac
  • psoriasis
  • insect bites
  • cosmetics
  • jewelry
  • detergents
  • soaps

temporarily relieves external anal and genital itching

other uses of this product should be only under the advise and supervision of a doctor

Section 51945-4 (51945-4)

Purpose

Anti-itch

Warnings

For external use only

Directions

adults and children 2 years and over: apply to affected area not more than 3 to 4 times daily

children under 2 years: ask a doctor

for external anal itching in adults:

  • when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly, or by patting or blotting with an appropriate cleansing pad
  • gently dry by patting or blotting with toilet tissue or a soft cloth before applying

for external anal itching in children under 12 years: ask a doctor

Do Not Use (Do not use)
  • for the treatment of diaper rash. Ask a doctor.
  • for external genital itching if you have a vaginal discharge. Ask a doctor.
  • for external anal itching if rectal bleeding occurs. Consult a doctor promptly.
Active Ingredient (Active ingredient)

Hydrocortisone 1%

Other Information (Other information)
  • store at 20ºC to 25ºC (68ºF to 77ºF)
Inactive Ingredient (Inactive ingredient)

white petrolatum

When Using This Product (When using this product)
  • do not get in the eyes
  • for external anal itching, do not use more than directed unless told to do so by a doctor
  • do not put 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)
  • condition gets worse, or if symptoms last for more than 7 days or clear up and occur again within a few days. Do not begin use of any other hydrocortisone product.
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.


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Raw Label Data

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