Hydrocortisone Cream 1%

Hydrocortisone Cream 1%
SPL v11
SPL
SPL Set ID 4c96ec41-841c-322b-e054-00144ff8d46c
Route
TOPICAL
Published
Effective Date 2025-04-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrocortisone (1 g)
Inactive Ingredients
Polysorbate 60 Edetate Disodium Water Sorbitan Stearate Petrolatum Aloe Vera Leaf Cetyl Alcohol Glyceryl Mono- And Dipalmitostearate Methylparaben Mineral Oil Propylene Glycol Propylparaben

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2017-04-07

Description

Hydrocortisone 1%

Purpose

Anti-Itch


Medication Information

Purpose

Anti-Itch

Description

Hydrocortisone 1%

Uses

Temporarily relieves itching associated with minor skin irritations, inflammation and rashes due to:

  • eczema
  • seborrheic dermatitis
  • psoriasis
  • insect bites
  • poison ivy, oak, sumac
  • soaps
  • detergents
  • cosmetics
  • jewelry
  • external genital and anal itching

Other uses of this product should be only under the advice and supervision of a doctor

Label

Warnings
  • for external use only
  • avoid contact with eyes
  • do not put this product into the rectum by using fingers or any mechanical device or applicator

For External Anal Itching Users:

  • do not exceed the recommended daily dosage unless directed by a doctor
  • in case of bleeding, consult a doctor promptly
  • children under 12 years of age: consult a doctor

Before using any medication, read all label directions. Keep this carton as it contains important information

Directions
  • 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 applying
  • adults and children 12 years of age and older, apply to the affected area not more than 3 to 4 times daily
  • children under 12 years of age: do not use, consult a doctor
Package Label

Active Ingredient

Hydrocortisone 1%

Other Information
  • to open; unscrew cap and pull tab to remove foil seal
  • if seal has been broken, do not use this product. Return product to the store where you bought it
  • store at controlled room temperature 15°-30°C (59°-86°F)
  • see carton or tube crimp for lot number and expiration date
Inactive Ingredients

Aloe barbadensis leaf juice, ethylparaben, glycerin, glycerol monostearate, hexadecanol, mineral water, octadecannol, petrolatum, purified water, sodium dodecyl sulfate

Keep Out of Reach of Children

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

Do Not Use This Product and Ask A Doctor
  • If you have a vaginal discharge
  • before treating diaper rash
  • before using on children under 2 years of age
Stop Using This Product and Ask A Doctor
  • in case of bleeding
  • if condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days
  • before you begin using any other hydrocortisone product

Structured Label Content

Uses

Temporarily relieves itching associated with minor skin irritations, inflammation and rashes due to:

  • eczema
  • seborrheic dermatitis
  • psoriasis
  • insect bites
  • poison ivy, oak, sumac
  • soaps
  • detergents
  • cosmetics
  • jewelry
  • external genital and anal itching

Other uses of this product should be only under the advice and supervision of a doctor

Label

Purpose

Anti-Itch

Warnings
  • for external use only
  • avoid contact with eyes
  • do not put this product into the rectum by using fingers or any mechanical device or applicator

For External Anal Itching Users:

  • do not exceed the recommended daily dosage unless directed by a doctor
  • in case of bleeding, consult a doctor promptly
  • children under 12 years of age: consult a doctor

Before using any medication, read all label directions. Keep this carton as it contains important information

Directions
  • 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 applying
  • adults and children 12 years of age and older, apply to the affected area not more than 3 to 4 times daily
  • children under 12 years of age: do not use, consult a doctor
Package Label

Active Ingredient

Hydrocortisone 1%

Other Information
  • to open; unscrew cap and pull tab to remove foil seal
  • if seal has been broken, do not use this product. Return product to the store where you bought it
  • store at controlled room temperature 15°-30°C (59°-86°F)
  • see carton or tube crimp for lot number and expiration date
Inactive Ingredients

Aloe barbadensis leaf juice, ethylparaben, glycerin, glycerol monostearate, hexadecanol, mineral water, octadecannol, petrolatum, purified water, sodium dodecyl sulfate

Keep Out of Reach of Children (Keep out of reach of children)

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

Do Not Use This Product and Ask A Doctor (Do not use this product and ask a doctor)
  • If you have a vaginal discharge
  • before treating diaper rash
  • before using on children under 2 years of age
Stop Using This Product and Ask A Doctor (Stop using this product and ask a doctor)
  • in case of bleeding
  • if condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days
  • before you begin using any other hydrocortisone product

Advanced Ingredient Data


Raw Label Data

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