Hydrocortisone 1% Cream

Hydrocortisone 1% Cream
SPL v9
SPL
SPL Set ID 9f0b09e7-6cfd-4fd6-8631-67799edf4e08
Route
TOPICAL
Published
Effective Date 2025-04-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrocortisone (1 g)
Inactive Ingredients
Cetostearyl Alcohol Propylene Glycol Water Sodium Lauryl Sulfate Petrolatum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2001-06-01

Description

Drug Facts

Purpose

Anti-itch cream


Medication Information

Purpose

Anti-itch cream

Description

Drug Facts

Uses
  • temporary relief of itching associated with minor skin irritations and rashes due to
    • eczema
    • insect bites
    • poison ivy, poison oak, or poison sumac
    • soaps
    • detergents
    • cosmetics
    • jewelry
    • seborrheic dermatitis
    • psoriasis
    • 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 productconsult 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 acetate (equivalent to 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

cetostearyl alcohol, propylene glycol, purified water, sodium lauryl sulfate, 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 Carton

Itch and Rash Relief

Hydrocortisone 1%

Cream

Hydrocortisone Acetate

Antipruritic (Anti-Itch)

MAXIMUM STRENGTH

NET WT 1 oz (28.4 g)


Structured Label Content

Uses
  • temporary relief of itching associated with minor skin irritations and rashes due to
    • eczema
    • insect bites
    • poison ivy, poison oak, or poison sumac
    • soaps
    • detergents
    • cosmetics
    • jewelry
    • seborrheic dermatitis
    • psoriasis
    • 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 productconsult a doctor before exceeding recommended dosage

Purpose

Anti-itch cream

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 acetate (equivalent to 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)

cetostearyl alcohol, propylene glycol, purified water, sodium lauryl sulfate, 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 Carton (PRINCIPAL DISPLAY PANEL - 28.4 g Carton)

Itch and Rash Relief

Hydrocortisone 1%

Cream

Hydrocortisone Acetate

Antipruritic (Anti-Itch)

MAXIMUM STRENGTH

NET WT 1 oz (28.4 g)


Advanced Ingredient Data


Raw Label Data

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