SPL v1
SPL
SPL Set ID 37ce6c35-b211-43de-e063-6294a90ab773
Route
TOPICAL
Published
Effective Date 2025-06-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrocortisone (1 g)
Inactive Ingredients
Cetostearyl Alcohol Propylene Glycol Water White Petrolatum Chlorocresol Mineral Oil Ceteareth-20

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-06-17
Description

Hydrocortisone 1%

Medication Information

Description

Hydrocortisone 1%

Uses
  • For the temporary relief of itchng associtated with minor skin irritations, inflammation, and rashes due to eczema, psoriasis, poison ivy, poison oak, poison sumac, insect bites, detergents, jewelry, seborrheic dermatitis, and soaps
  • Other uses of this product should be onl under the advise and supervision of a doctor
Section 51945-4

Section 55105-1

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
Do Not Use

Do not use for the treatment of diaper rash. Consult a doctor

Active Ingredient

Hydrocortisone 1%

Inactive Ingredients

Ceteareth 20, Cetostearyl Alcohol, Chlorocresol, Mineral Oil, Propylene Glycol, Purified Water, White Petrolatum

When Using This Product

When using this product

  • avoid contact with eyes
  • do not begin use of any other hydrocortisone product unless you have consulted a doctor
Stop Use and Ask A Doctor If

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
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.

Structured Label Content

Uses
  • For the temporary relief of itchng associtated with minor skin irritations, inflammation, and rashes due to eczema, psoriasis, poison ivy, poison oak, poison sumac, insect bites, detergents, jewelry, seborrheic dermatitis, and soaps
  • Other uses of this product should be onl under the advise and supervision of a doctor
Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

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
Do Not Use (Do not use)

Do not use for the treatment of diaper rash. Consult a doctor

Active Ingredient

Hydrocortisone 1%

Inactive Ingredients

Ceteareth 20, Cetostearyl Alcohol, Chlorocresol, Mineral Oil, Propylene Glycol, Purified Water, White Petrolatum

When Using This Product (When using this product)

When using this product

  • avoid contact with eyes
  • do not begin use of any other hydrocortisone product unless you have consulted a doctor
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

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
Keep Out of Reach of Children (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

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:06:19.696843 · Updated: 2026-03-14T23:09:03.764166