SPL v1
SPL
SPL Set ID 0df06415-5d32-7ef8-e063-6294a90a6e5a
Route
TOPICAL
Published
Effective Date 2024-01-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrocortisone (10 mg)
Inactive Ingredients
Ceteareth-12 Propylene Glycol Methylparaben Edetate Disodium Trolamine Sodium Cetostearyl Sulfate Propylparaben Water Cetostearyl Alcohol Mineral Oil .alpha.-tocopherol Stearic Acid Aloe Vera Leaf

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-01-01

Description

Hydrocortisone, USP 1%

Purpose

Anti-itch


Medication Information

Indications and Usage

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

•eczema

•insect bites

•poison ivy

•poison oak

•poison ...

Purpose

Anti-itch

Description

Hydrocortisone, USP 1%

Section 50570-1

for external feminine itching if you have a vaginal discharge. Consult a doctor.

for the treatment of diaper rash. Consult a doctor.

Section 51945-4

Warnings

For external use only

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
  • For external anal itching
  • Adults: when practical, clean the affected area with mild soap and warm water, rinse thoroughly, gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product

Active Ingredient

Hydrocortisone, USP 1%

Other Information

  • Store at room temperature 59°-86°F (15°-30°C).
  • Protect from freezing.
  • Before using any medication, read all label directions. Keep carton, it contains important information.
Inactive Ingredients

cetostearyl alcohol, sodium cetostearyl sulfate, stearic acid, trolamine, mineral oil , propylene glycol, water, methyl paraben, propyl paraben, EDTA, vitamin E, Aloe vera leaf.

When Using This Product

•avoid contact with the eyes

•do not begin the use of any other hydrocortisone product unless directed by a doctor

•for external anal itching:

do not use more than directed unless directed by a doctor

do not put this product 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 right away.

Stop Use and Ask Your Doctor If

•symptoms last for more than 7 days

•the condition gets worse

•symptoms clear up and occur again in a few days

•rectal bleeding occurs, consult doctor promptly


Structured Label Content

Indications and Usage (34067-9)

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

•eczema

•insect bites

•poison ivy

•poison oak

•poison ...

Section 50570-1 (50570-1)

for external feminine itching if you have a vaginal discharge. Consult a doctor.

for the treatment of diaper rash. Consult a doctor.

Section 51945-4 (51945-4)

Purpose (PURPOSE)

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
  • For external anal itching
  • Adults: when practical, clean the affected area with mild soap and warm water, rinse thoroughly, gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product

Active Ingredient (ACTIVE INGREDIENT)

Hydrocortisone, USP 1%

Other Information (OTHER INFORMATION)

  • Store at room temperature 59°-86°F (15°-30°C).
  • Protect from freezing.
  • Before using any medication, read all label directions. Keep carton, it contains important information.
Inactive Ingredients (INACTIVE INGREDIENTS)

cetostearyl alcohol, sodium cetostearyl sulfate, stearic acid, trolamine, mineral oil , propylene glycol, water, methyl paraben, propyl paraben, EDTA, vitamin E, Aloe vera leaf.

When Using This Product (WHEN USING THIS PRODUCT)

•avoid contact with the eyes

•do not begin the use of any other hydrocortisone product unless directed by a doctor

•for external anal itching:

do not use more than directed unless directed by a doctor

do not put this product into the rectum by using fingers or any mechanical device or applicator

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.

Stop Use and Ask Your Doctor If (STOP USE AND ASK YOUR DOCTOR IF)

•symptoms last for more than 7 days

•the condition gets worse

•symptoms clear up and occur again in a few days

•rectal bleeding occurs, consult doctor promptly


Advanced Ingredient Data


Raw Label Data

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