Hydrocortisone Cream 1%

Hydrocortisone Cream 1%
SPL v7
SPL
SPL Set ID d57a59fb-c8f2-f73b-e053-2995a90a4cdb
Route
TOPICAL
Published
Effective Date 2025-05-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrocortisone (1 g)
Inactive Ingredients
Edetic Acid Maltodextrin Ginger Oil Polysorbate 80 Stearic Acid Methyl Gluceth-20 3-methylpentadecane Phenoxyethanol Ethylparaben Dimethicone Glycerin Glyceryl Monostearate Petrolatum Aloe Vera Leaf Cetyl Alcohol Water Trisodium Citrate Dihydrate Methylparaben Propylene Glycol .alpha.-tocopherol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-01-13

Description

Hydrocortisone 1%

Purpose

Anti-Itch


Medication Information

Purpose

Anti-Itch

Description

Hydrocortisone 1%

Uses

For temporarily rellief of itching associated with minor skin irritations, inflammation and rashes due to:

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

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

Warnings
  • for external use only

Questions

Call 1-888-296-9067

Directions

For itching of skin irritation, inflammation, and rashes:

Adults and Children 2 years and older

  • Apply to affected area not more than 3 to 4 times daily.

Children under 2 years of age: ask a doctor

For external anal and genital itching, adults:

  • When practical, clean 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.
  • Apply to affected area not more than 3 to 4 times daily

  • Children under 12 years of age; ask 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.

Package Label

Active Ingredient

Hydrocortisone 1%

Other Information
  • store at controlled room temperature 20°- 25°C (68°-77°F)

Inactive Ingredients

Aloe barbadensis leaf juice, Cetyl alcohol, Dimethicone, EDTA, Ethylparaben, Ginger Oil, glycerin, Glycerol Stearate, Maltodextrin, Methyl gluceth-20, Methylparaben, Methylpentadecane, petrolatum, 2-Phenoxyethanol, Polysorbate 80, Propylene Glycol, purified water, Stearic Acid, Trisodium citrate dihydrate, Vitamin E.

When Using This Product

When using this product

  • avoid contact with the eyes
  • Do not use more than directed unless told to do so by a doctor
  • Do not put directly into the rectum by using fingers or any mechanical device or applicator.
Keep Out of Reach of Children

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

Stop Using This Product and Ask A Doctor
  • Conditions worsen, symptoms persist for more than 7 days or clear up and occur again within a few days. Do not begin use of any other hydrocortisone product unless you have asked a doctor.
  • Rectal bleeding occurs

Structured Label Content

Uses

For temporarily rellief of itching associated with minor skin irritations, inflammation and rashes due to:

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

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

Purpose

Anti-Itch

Warnings
  • for external use only

Questions

Call 1-888-296-9067

Directions

For itching of skin irritation, inflammation, and rashes:

Adults and Children 2 years and older

  • Apply to affected area not more than 3 to 4 times daily.

Children under 2 years of age: ask a doctor

For external anal and genital itching, adults:

  • When practical, clean 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.
  • Apply to affected area not more than 3 to 4 times daily

  • Children under 12 years of age; ask a doctor.

Do Not Use (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.

Package Label

Active Ingredient

Hydrocortisone 1%

Other Information
  • store at controlled room temperature 20°- 25°C (68°-77°F)

Inactive Ingredients

Aloe barbadensis leaf juice, Cetyl alcohol, Dimethicone, EDTA, Ethylparaben, Ginger Oil, glycerin, Glycerol Stearate, Maltodextrin, Methyl gluceth-20, Methylparaben, Methylpentadecane, petrolatum, 2-Phenoxyethanol, Polysorbate 80, Propylene Glycol, purified water, Stearic Acid, Trisodium citrate dihydrate, Vitamin E.

When Using This Product (When using this product)

When using this product

  • avoid contact with the eyes
  • Do not use more than directed unless told to do so by a doctor
  • Do not put directly into the rectum by using fingers or any mechanical device or applicator.
Keep Out of Reach of Children (Keep out of reach of children)

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

Stop Using This Product and Ask A Doctor (Stop using this product and ask a doctor)
  • Conditions worsen, symptoms persist for more than 7 days or clear up and occur again within a few days. Do not begin use of any other hydrocortisone product unless you have asked a doctor.
  • Rectal bleeding occurs

Advanced Ingredient Data


Raw Label Data

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