Hydrocortisone Ointment 1%

Hydrocortisone Ointment 1%
SPL v1
SPL
SPL Set ID c22bba5c-bb6f-494e-987a-f6e36c1b4893
Route
TOPICAL
Published
Effective Date 2025-03-06
Document Type 34390-5 Human OTC Drug Label

Drug Facts

Composition & Product

Active Ingredients
Hydrocortisone (1 g)
Inactive Ingredients
Cetyl Alcohol Glyceryl Stearate Isopropyl Myristate Methylparaben Polyoxyl 40 Stearate Polysorbate 40 Propylene Glycol Propylparaben Water Sorbic Acid Sorbitan Monostearate Stearyl Alcohol White Wax Sodium Citrate

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-03-06
Description

Hydrocortisone, USP 1%

Purpose

Anti-itch

Medication Information

Purpose

Anti-itch

Description

Hydrocortisone, USP 1%

Use(s)

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

  • eczema
  • insect bites
  • poison ivy
  • poison oak
  • poison sumac
  • soaps
  • jewelry
  • detergents
  • cosmetics
  • psoriasis
  • seborrheic dermatitis
  • for external genital, feminine and anal itching
  • other uses of this product should be only under the advice and supervision of a doctor


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, 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.

Children under 12 years of age: consult a doctor

Do Not Use
  • for external feminine itching if you have a vaginal discharge.  Consult a doctor.
  • for the treatment of diaper rash.  Consult a doctor.
Questions?

1-833-285-4151 between 9 am and 4 pm EST, Monday-Friday. 

Other Information
  • Store at room temperature 590-860F (150-300C). Protect from freezing. 
  • Before using any medication, read all label directions. Keep carton, it contains important information.
Inactive Ingredient

cetyl alcohol, glyceryl stearate, isopropyl myristate, methylparaben, polyoxyl 40 stearate, polysorbate 60, propylene glycol, propylparaben, purified water, sorbic acid, sorbitan monostearate, stearyl alcohol, white wax, May contain citric acid or sodium citrate solution to adjust pH.

Active Ingredient(s)

Hydrocortisone, USP 1%

Principal Display Panel
When Using This Product
  • avoid contact with the eyes
  • do not begin the use of any other hydrocortisone product unless directed by a doctor
  • for external anal itching:
  • do not use more than directed unless directed by a doctor
  • do not put this product into the rectum by using fingers or any mechanical device or applicator
Stop Use and Ask A Doctor If
  • symptoms last for more than 7 days
  • the condition gets worse, symptoms clear up and occur again in a few days
  • rectal bleeding occurs, consult doctor promptly
Keep Out of Reach of Children

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

Structured Label Content

Use(s) (USE(S))

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

  • eczema
  • insect bites
  • poison ivy
  • poison oak
  • poison sumac
  • soaps
  • jewelry
  • detergents
  • cosmetics
  • psoriasis
  • seborrheic dermatitis
  • for external genital, feminine and anal itching
  • other uses of this product should be only under the advice and supervision of a doctor


Purpose (PURPOSE)

Anti-itch

Warnings (WARNINGS)

For external use only

Directions (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, 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.

Children under 12 years of age: consult a doctor

Do Not Use (DO NOT USE)
  • for external feminine itching if you have a vaginal discharge.  Consult a doctor.
  • for the treatment of diaper rash.  Consult a doctor.
Questions? (QUESTIONS?)

1-833-285-4151 between 9 am and 4 pm EST, Monday-Friday. 

Other Information (OTHER INFORMATION)
  • Store at room temperature 590-860F (150-300C). Protect from freezing. 
  • Before using any medication, read all label directions. Keep carton, it contains important information.
Inactive Ingredient (INACTIVE INGREDIENT)

cetyl alcohol, glyceryl stearate, isopropyl myristate, methylparaben, polyoxyl 40 stearate, polysorbate 60, propylene glycol, propylparaben, purified water, sorbic acid, sorbitan monostearate, stearyl alcohol, white wax, May contain citric acid or sodium citrate solution to adjust pH.

Active Ingredient(s) (ACTIVE INGREDIENT(S))

Hydrocortisone, USP 1%

Principal Display Panel (PRINCIPAL DISPLAY PANEL)
When Using This Product (WHEN USING THIS PRODUCT)
  • avoid contact with the eyes
  • do not begin the use of any other hydrocortisone product unless directed by a doctor
  • for external anal itching:
  • do not use more than directed unless directed by a doctor
  • do not put this product 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)
  • symptoms last for more than 7 days
  • the condition gets worse, symptoms clear up and occur again in a few days
  • rectal bleeding occurs, consult doctor promptly
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.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:40.821048 · Updated: 2026-03-14T23:07:51.764628