Hydrocortisone

Hydrocortisone
SPL v4
SPL
SPL Set ID c57d5f8e-5934-4cbb-999a-cdd55e5b105f
Route
TOPICAL
Published
Effective Date 2024-02-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrocortisone (1 g)
Inactive Ingredients
Medium-chain Triglycerides Methylparaben Propylparaben Petrolatum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 1989-10-03

Description

Drug Facts

Purpose

Anti-itch ointment


Medication Information

Purpose

Anti-itch ointment

Description

Drug Facts

Uses
  • temporary relief of itching associated with minor skin irritations and rashes due to
    • o
      eczema
    • o
      insect bites
    • o
      poison ivy, poison oak, or poison sumac
    • o
      soaps
    • o
      detergents
    • o
      cosmetics
    • o
      jewelry
    • o
      seborrheic dermatitis
    • o
      psoriasis
    • o
      external genital and anal 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 right away.

Section 50567-7

When using this product consult a doctor before exceeding recommended dosage

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, 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 application of this product

Children under 12 years of age: consult a doctor

Do Not Use
  • in the eyes
  • by putting this product into the rectum by using fingers or any mechanical device or applicator
Questions?

Call 1-866-923-4914

Active Ingredient

Hydrocortisone 1%

Other Information
  • To open: unscrew cap, pull tab to remove foil seal, and screw cap back onto tube
  • store at room temperature
  • see carton or tube crimp for lot number and expiration date
Inactive Ingredients

Fractionated Coconut Oil, Methylparaben, Propylparaben, White Petrolatum

Stop Use and Ask A Doctor If
  • condition gets worse
  • condition persists for more than 7 days
  • condition clears up and occurs again within a few days. Do not begin to use any other hydrocortisone product unless you have consulted a doctor.
Ask A Doctor Before Use If You Have
  • a vaginal discharge
  • rectal bleeding
  • diaper rash
Principal Display Panel 28.4 G Tube Carton

Itch and Rash Relief

MAXIMUM STRENGTH

Hydrocortisone 1%

Ointment

Antipruritic (Anti-Itch)

NET WT 1 oz (28.4 g)


Structured Label Content

Uses
  • temporary relief of itching associated with minor skin irritations and rashes due to
    • o
      eczema
    • o
      insect bites
    • o
      poison ivy, poison oak, or poison sumac
    • o
      soaps
    • o
      detergents
    • o
      cosmetics
    • o
      jewelry
    • o
      seborrheic dermatitis
    • o
      psoriasis
    • o
      external genital and anal 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 right away.

Section 50567-7 (50567-7)

When using this product consult a doctor before exceeding recommended dosage

Purpose

Anti-itch ointment

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, 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 application of this product

Children under 12 years of age: consult a doctor

Do Not Use (Do not use)
  • in the eyes
  • by putting this product into the rectum by using fingers or any mechanical device or applicator
Questions?

Call 1-866-923-4914

Active Ingredient (Active ingredient)

Hydrocortisone 1%

Other Information (Other information)
  • To open: unscrew cap, pull tab to remove foil seal, and screw cap back onto tube
  • store at room temperature
  • see carton or tube crimp for lot number and expiration date
Inactive Ingredients (Inactive ingredients)

Fractionated Coconut Oil, Methylparaben, Propylparaben, White Petrolatum

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • condition gets worse
  • condition persists for more than 7 days
  • condition clears up and occurs again within a few days. Do not begin to use any other hydrocortisone product unless you have consulted a doctor.
Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • a vaginal discharge
  • rectal bleeding
  • diaper rash
Principal Display Panel 28.4 G Tube Carton (PRINCIPAL DISPLAY PANEL - 28.4 g Tube Carton)

Itch and Rash Relief

MAXIMUM STRENGTH

Hydrocortisone 1%

Ointment

Antipruritic (Anti-Itch)

NET WT 1 oz (28.4 g)


Advanced Ingredient Data


Raw Label Data

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