Hydrocortisone Maximum Strength

Hydrocortisone Maximum Strength
SPL v3
SPL
SPL Set ID 66cf83dd-4205-4ae7-a7d4-7e0e1aebaadf
Route
TOPICAL
Published
Effective Date 2022-06-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrocortisone (1 g)
Inactive Ingredients
Mineral Oil White Petrolatum

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2021-06-29

Description

Drug Facts

Purpose

Anti-itch

How Supplied

Product: 50090-5856 NDC: 50090-5856-0 28 g in a TUBE / 1 in a CARTON


Medication Information

Purpose

Anti-itch

How Supplied

Product: 50090-5856

NDC: 50090-5856-0 28 g in a TUBE / 1 in a CARTON

Description

Drug Facts

Uses
  • temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to
    • eczema
    • psoriasis
    • insect bites
    • poison ivy, oak, sumac
    • detergents
    • jewelry
    • cosmetics
    • soaps
    • seborrheic dermatitis
  • temporarily relieves external anal and genital itching
  • other uses of this product should be only under the advice and supervision of a doctor
Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

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: consult a doctor
  • for external anal and genital 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
    • apply to affected area not more than 3 to 4 times daily
    • children under 12 years of age: consult a doctor
Do Not Use
  • in the genital area if you have a vaginal discharge. Consult a doctor.
  • for the treatment of diaper rash. Consult a doctor.
Hydrocortisone
Active Ingredient

Hydrocortisone USP, 1%

Other Information
  • store at 15°-30°C (59°-86°F). Protect from freezing.
  • before using any medication, read all label directions. Keep carton, it contains important information.
Inactive Ingredients

mineral oil, white petrolatum

Questions Or Comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

When Using This Product
  • avoid contact with the eyes
  • do not use more than directed unless directed 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, symptoms persist for more than 7 days or clear up and occur again within a few days
  • do not begin the use of any other hydrocortisone product unless directed by a doctor
  • rectal bleeding occurs

Structured Label Content

Uses
  • temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to
    • eczema
    • psoriasis
    • insect bites
    • poison ivy, oak, sumac
    • detergents
    • jewelry
    • cosmetics
    • soaps
    • seborrheic dermatitis
  • temporarily relieves external anal and genital itching
  • other uses of this product should be only under the advice and supervision of a doctor
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

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: consult a doctor
  • for external anal and genital 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
    • apply to affected area not more than 3 to 4 times daily
    • children under 12 years of age: consult a doctor
Do Not Use (Do not use)
  • in the genital area if you have a vaginal discharge. Consult a doctor.
  • for the treatment of diaper rash. Consult a doctor.
How Supplied (HOW SUPPLIED)

Product: 50090-5856

NDC: 50090-5856-0 28 g in a TUBE / 1 in a CARTON

Hydrocortisone (hydrocortisone)
Active Ingredient (Active ingredient)

Hydrocortisone USP, 1%

Other Information (Other information)
  • store at 15°-30°C (59°-86°F). Protect from freezing.
  • before using any medication, read all label directions. Keep carton, it contains important information.
Inactive Ingredients (Inactive ingredients)

mineral oil, white petrolatum

Questions Or Comments? (Questions or comments?)

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

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

Advanced Ingredient Data


Raw Label Data

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