Hydrocortisone Anti-itch Cream

Hydrocortisone Anti-itch Cream
SPL v1
SPL
SPL Set ID b6599a77-37c1-deec-e053-2995a90abd0e
Route
TOPICAL
Published
Effective Date 2020-11-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrocortisone (0.01 g)
Inactive Ingredients
Water Mineral Oil Propylene Glycol Cetostearyl Alcohol Petrolatum Glyceryl Monostearate Polysorbate 60 Sorbitan Monostearate Methylparaben Propylparaben Edetate Sodium

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-12-09
Description

Active Ingredient Hydrocortisone 1%

Medication Information

Warnings and Precautions

Warnings

For external use only

Indications and Usage

Uses

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

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

Other uses or the use of the product for more than 7 days should be undertaken only under the advice and supervision of a doctor

Dosage and Administration

Directions

For itching of skin irritation, inflammation, and rashes:

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: Ask a doctor

For external anal and genital itching, adults:

When practical, clean the affected area with mild soap and 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.

Description

Active Ingredient Hydrocortisone 1%

Section 42229-5

Other information

  • Store at 20ºC to 25º C (68ºF to 77º F)
  • Lot No. & Exp. Date: see crimp of tube
Section 50565-1

Keep out of reach of children.

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

Section 50566-9

Stop use and ask a doctor if

condition worsens, symptoms persist for more than 7 days or clear up and occur again within a few days, and do not begin use of any other hydrocortisone product unless you have asked a doctor. Rectal bleeding occurs.

Section 50567-7

When using this product

  • Avoid contact with 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
Section 50570-1

Do not use in genital area if you have a vaginal discharge.

Consult a doctor, for the treatment of diaper rash. Ask a doctor.

Section 51727-6

Inactive Ingredients

Purified Water, Mineral Oil, Propylene Glycol, Cetearyl Alcohol, Petrolatum, Glyceryl Stearate, Polysorbate 60, Sorbitan Stearate, Methylparaben, Propylparaben, Disodium Edta

Section 51945-4

PRINCIPAL DISPLAY PANEL

HYDROCORTISONE ANTI-ITCH CREAM

NET WT 0.5 OZ. (14 g)

Section 55105-1

Purpose

Anti-itch

Section 55106-9

Active Ingredient

Hydrocortisone 1%

Structured Label Content

Indications and Usage (34067-9)

Uses

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

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

Other uses or the use of the product for more than 7 days should be undertaken only under the advice and supervision of a doctor

Dosage and Administration (34068-7)

Directions

For itching of skin irritation, inflammation, and rashes:

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: Ask a doctor

For external anal and genital itching, adults:

When practical, clean the affected area with mild soap and 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.

Warnings and Precautions (34071-1)

Warnings

For external use only

Section 42229-5 (42229-5)

Other information

  • Store at 20ºC to 25º C (68ºF to 77º F)
  • Lot No. & Exp. Date: see crimp of tube
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 50566-9 (50566-9)

Stop use and ask a doctor if

condition worsens, symptoms persist for more than 7 days or clear up and occur again within a few days, and do not begin use of any other hydrocortisone product unless you have asked a doctor. Rectal bleeding occurs.

Section 50567-7 (50567-7)

When using this product

  • Avoid contact with 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
Section 50570-1 (50570-1)

Do not use in genital area if you have a vaginal discharge.

Consult a doctor, for the treatment of diaper rash. Ask a doctor.

Section 51727-6 (51727-6)

Inactive Ingredients

Purified Water, Mineral Oil, Propylene Glycol, Cetearyl Alcohol, Petrolatum, Glyceryl Stearate, Polysorbate 60, Sorbitan Stearate, Methylparaben, Propylparaben, Disodium Edta

Section 51945-4 (51945-4)

PRINCIPAL DISPLAY PANEL

HYDROCORTISONE ANTI-ITCH CREAM

NET WT 0.5 OZ. (14 g)

Section 55105-1 (55105-1)

Purpose

Anti-itch

Section 55106-9 (55106-9)

Active Ingredient

Hydrocortisone 1%

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:59:10.622627 · Updated: 2026-03-14T22:59:03.562738