Hydrocortisone Cream

Hydrocortisone Cream
SPL v4
SPL
SPL Set ID 8b8cdb26-8e8f-4e95-9d83-d685c90afe01
Route
TOPICAL
Published
Effective Date 2026-01-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrocortisone (10 mg)
Inactive Ingredients
Aloe Vera Leaf Cetyl Alcohol Edetate Disodium Methylparaben Mineral Oil Petrolatum Polysorbate 60 Propylene Glycol Propylparaben Water Sorbitan Monostearate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-08-30

Description

Hydrocortisone 1%

Purpose

Anti-itch


Medication Information

Purpose

Anti-itch

Description

Hydrocortisone 1%

Uses
  • temporary relief of external anal itching
  • temporary relief of itching associated with minor skin irritations and rashes
  • other uses of this product should be only under the advice and supervision of a doctor
Warnings

For external use only.

Directions

Adults:

  • when practical, cleanse the affected area by patting or blotting with an appropriate cleansing wipe. Gently dry by patting or blotting with a tissue or soft cloth before application of this product.
  • 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
Do Not Use

for the treatment of diaper rash. Consult a doctor.

Drug Facts

Questions?

1-800-639-3803 Weekdays 9 AM to 4 PM EST

Active Ingredient

Hydrocortisone 1%

Other Information

store at room temperature 68° - 77° F (20° - 25° C)

Package Labeling:

Inactive Ingredients

aloe barbadensis leaf juice, cetyl alcohol, edetate disodium, methylparaben, mineral oil, mono- and di-glycerides, petrolatum, polysorbate 60, propylene glycol, propylparaben, purified water, sorbitan monostearate

When Using This Product
  • avoid contact with the eyes
  • do not exceed the recommended daily dosage unless directed by a doctor
  • do not put into the rectum by using fingers or any mechanical device or applicator
Stop Use and Ask A Doctor If
  • bleeding occurs
  • condition worsens
  • 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 consulted a doctor.
Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).


Structured Label Content

Uses
  • temporary relief of external anal itching
  • temporary relief of itching associated with minor skin irritations and rashes
  • other uses of this product should be only under the advice and supervision of a doctor
Purpose

Anti-itch

Warnings

For external use only.

Directions

Adults:

  • when practical, cleanse the affected area by patting or blotting with an appropriate cleansing wipe. Gently dry by patting or blotting with a tissue or soft cloth before application of this product.
  • 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
Do Not Use (Do not use)

for the treatment of diaper rash. Consult a doctor.

Drug Facts

Questions?

1-800-639-3803 Weekdays 9 AM to 4 PM EST

Active Ingredient (Active ingredient)

Hydrocortisone 1%

Other Information (Other information)

store at room temperature 68° - 77° F (20° - 25° C)

Package Labeling:

Inactive Ingredients (Inactive ingredients)

aloe barbadensis leaf juice, cetyl alcohol, edetate disodium, methylparaben, mineral oil, mono- and di-glycerides, petrolatum, polysorbate 60, propylene glycol, propylparaben, purified water, sorbitan monostearate

When Using This Product (When using this product)
  • avoid contact with the eyes
  • do not exceed the recommended daily dosage unless directed by a doctor
  • do not put 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)
  • bleeding occurs
  • condition worsens
  • 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 consulted a doctor.
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 (1-800-222-1222).


Advanced Ingredient Data


Raw Label Data

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