Hydrocortisone 1% Cream

Hydrocortisone 1% Cream
SPL v3
SPL
SPL Set ID b3bdff5e-37fe-442a-a370-7b19799ea781
Route
TOPICAL
Published
Effective Date 2025-10-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrocortisone (10 mg)
Inactive Ingredients
Phenoxyethanol Aloe Vera Leaf Cetyl Alcohol Dimethicone Edetic Acid Ethylparaben Ginger Oil Glycerin Maltodextrin Methyl Gluceth-20 Methylparaben Petrolatum Polysorbate 80 Propylene Glycol Water Stearic Acid Trisodium Citrate Dihydrate .alpha.-tocopherol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-10-15

Description

Hydrocortisone 1%

Purpose

Anti-itch


Medication Information

Purpose

Anti-itch

Description

Hydrocortisone 1%

Uses

temporarily relieves itching associated with minor skin irritations, inflammation and rashes due to:

• eczema • psoriasis • poison ivy, oak, sumac • insect bites • sunburn • detergents • jewelry • cosmetics • soaps • seborrheic dermatitis • temporarily relieves external anal and genital itching • other uses of this product should be under advice and supervision of a doctor

Warnings

For external use only.

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 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 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
  • in the genital area if you have a vaginal discharge. Consult a doctor.
  • for the treatment of diaper rash. Consult a doctor.
Questions?

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

Other Information
  • store at room temperature 68°-77°F(20°-25°C).
  • tamper-evident: do not use if foil seal is broken or missing.
Package Labeling:

Inactive Ingredients

2-phenoxyethanol, aloe barbadensis leaf juice, cetyl alcohol, dimethicone, EDTA, ethylparaben, ginger oil, glycerin, glyceryl stearate, maltodextrin, methyl gluceth-20, methylparaben, methylpentadecane, petrolatum, polysorbate 80, propylene glycol, purified water, stearic acid, trisodium citrate dihydrate, vitamin E

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
Stop Use and Ask A Doctor If
  • condition worsens, symptoms persists 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
Keep Out of Reach of Children

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

Active Ingredient (in Each Gram)

Hydrocortisone 1%


Structured Label Content

Uses

temporarily relieves itching associated with minor skin irritations, inflammation and rashes due to:

• eczema • psoriasis • poison ivy, oak, sumac • insect bites • sunburn • detergents • jewelry • cosmetics • soaps • seborrheic dermatitis • temporarily relieves external anal and genital itching • other uses of this product should be under advice and supervision of a doctor

Purpose

Anti-itch

Warnings

For external use only.

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 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 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.
Questions?

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

Other Information (Other information)
  • store at room temperature 68°-77°F(20°-25°C).
  • tamper-evident: do not use if foil seal is broken or missing.
Package Labeling:

Inactive Ingredients (Inactive ingredients)

2-phenoxyethanol, aloe barbadensis leaf juice, cetyl alcohol, dimethicone, EDTA, ethylparaben, ginger oil, glycerin, glyceryl stearate, maltodextrin, methyl gluceth-20, methylparaben, methylpentadecane, petrolatum, polysorbate 80, propylene glycol, purified water, stearic acid, trisodium citrate dihydrate, vitamin E

When Using This Product (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
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • condition worsens, symptoms persists 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
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.

Active Ingredient (in Each Gram) (Active ingredient (in each gram))

Hydrocortisone 1%


Advanced Ingredient Data


Raw Label Data

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