Hydrocortisone 1% Drug Facts

Hydrocortisone 1% Drug Facts
SPL v2
SPL
SPL Set ID 99726aa3-3b45-4175-8471-279419af5457
Route
TOPICAL
Published
Effective Date 2024-09-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrocortisone (1 g)
Inactive Ingredients
Aloe Vera Leaf Petrolatum

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2011-08-18

Description

Hydrocortisone 1%

Purpose

Anti-itch

How Supplied

Hydrocortisone 1% Maximum Strength Anti-Itch Ointment NDC 72162-2284-2: 28 g in a TUBE Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504


Medication Information

Purpose

Anti-itch

How Supplied

Hydrocortisone 1% Maximum Strength Anti-Itch Ointment

  • NDC 72162-2284-2: 28 g in a TUBE

Repackaged/Relabeled by:

Bryant Ranch Prepack, Inc.

Burbank, CA 91504

Description

Hydrocortisone 1%

Uses
  • temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to:
    • eczema
    • psoriasis
    • poison ivy, oak, sumac
    • insect bites
    • detergents
    • jewelry
    • cosmetics
    • soaps
    • seborrheic dermatitis
  • temporarily relieves external anal and genital itching
  • other uses of this product should only be under the advice and supervision of a doctor
Section 51945-4

Hydrocortisone 1% Maximum Strength Anti-Itch Ointment

Warnings

For external use only

Directions
  • for itching of skin irritation, inflammation, and rashes:
    • 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, ask a doctor
  • for external anal and genital itching, adults:
    • when practical, clean 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
    • apply to affected area not more than 3 to 4 times daily
    • children under 12 years of age: ask a doctor
Do Not Use
  • for the treatment of diaper rash. Ask a doctor.
  • in the genital area if you have a vaginal discharge. Ask a doctor.
Active Ingredient

Hydrocortisone 1%

Other Information
  • store at 20°-25°C (68°-77°F)
Inactive Ingredients

aloe barbadensis leaf juice, white petrolatum

Questions Or Comments?

1-800-719-9260

When Using This Product
  • avoid contact with the eyes
  • do not use more than directed unless told to do so by a doctor
  • do not put directly into the rectum by using fingers or any mechanical device or applicator
Stop Use and Ask A Doctor If
  • condition worsens
  • rectal bleeding occurs
  • symptoms persist for more than 7 days or clear up and occur again within a few days, and do not begin use of any other hydrocortisone product unless you have asked a doctor
Keep Out of Reach of Children.

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


Structured Label Content

Uses
  • temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to:
    • eczema
    • psoriasis
    • poison ivy, oak, sumac
    • insect bites
    • detergents
    • jewelry
    • cosmetics
    • soaps
    • seborrheic dermatitis
  • temporarily relieves external anal and genital itching
  • other uses of this product should only be under the advice and supervision of a doctor
Section 51945-4 (51945-4)

Hydrocortisone 1% Maximum Strength Anti-Itch Ointment

Purpose

Anti-itch

Warnings

For external use only

Directions
  • for itching of skin irritation, inflammation, and rashes:
    • 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, ask a doctor
  • for external anal and genital itching, adults:
    • when practical, clean 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
    • apply to affected area not more than 3 to 4 times daily
    • children under 12 years of age: ask a doctor
Do Not Use (Do not use)
  • for the treatment of diaper rash. Ask a doctor.
  • in the genital area if you have a vaginal discharge. Ask a doctor.
How Supplied (HOW SUPPLIED)

Hydrocortisone 1% Maximum Strength Anti-Itch Ointment

  • NDC 72162-2284-2: 28 g in a TUBE

Repackaged/Relabeled by:

Bryant Ranch Prepack, Inc.

Burbank, CA 91504

Active Ingredient (Active ingredient)

Hydrocortisone 1%

Other Information (Other information)
  • store at 20°-25°C (68°-77°F)
Inactive Ingredients (Inactive ingredients)

aloe barbadensis leaf juice, white petrolatum

Questions Or Comments? (Questions or comments?)

1-800-719-9260

When Using This Product (When using this product)
  • avoid contact with the eyes
  • do not use more than directed unless told to do so by a doctor
  • do not put directly 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 worsens
  • rectal bleeding occurs
  • symptoms persist for more than 7 days or clear up and occur again within a few days, and do not begin use of any other hydrocortisone product unless you have asked a doctor
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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