Hydrocortisone 1% Cream

Hydrocortisone 1% Cream
SPL v2
SPL
SPL Set ID 31431866-6fb5-2acd-e063-6294a90ac520
Route
TOPICAL
Published
Effective Date 2025-03-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrocortisone (10 mg)
Inactive Ingredients
Water Glycerin Phenoxyethanol Peg-100 Stearate Mineral Oil Cetyl Alcohol White Petrolatum Stearyl Alcohol Glyceryl Stearate Se Xanthan Gum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-03-28

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
  • insect bites
  • poison ivy, oak, or sumac
  • soaps
  • detergents
  • cosmetics
  • jewelry
  • seborrheic dermatitis
  • psoriarsis
  • temporarity relieves external anal and genital itching
  • other uses of this product should be only under the advice and supervision of a doctor
Warnings

For external use only

Jar Label

NDC 73141-622-54

Hydrocortisone Cream 1%

Maximum Strength Anti-Itch Cream

NET WT 1LB (454g)

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: do not use, ask a doctor
  • for external anal and genital itching, adults:
  • when practical, cleanse 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.
Carton Label

NDC 73141-622-28

Hydrocortisone Cream 1%

Maximum Strength Anti-Itch Cream

NET WT 1 OZ (28g)

Active Ingredient

Hydrocortisone 1%

Other Information
  • store at 20-25°C (68-77°F)
Inactive Ingredients

Cetyl alcohol, glycerin, glyceryl stearate SE, mineral oil, PEG-100 stearate, phenoxyethanol, purified water, stearyl alcohol, white petrolatum, xanthan gum

Questions Or Comments?

Call 1(800)380-6709

Distributed By:

A2A Integrated Pharmaceuticals

Bowling Green, KY 42101

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
  • rectal bleeding occurs
  • condition worsens, symptoms persist for more than 7 days or clear up and occur again within a few days, and do not use this or any other hydrocortisone product unless you have asked a doctor
Keep Out of Reach of Children.

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


Structured Label Content

Uses
  • temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to:
  • eczema
  • insect bites
  • poison ivy, oak, or sumac
  • soaps
  • detergents
  • cosmetics
  • jewelry
  • seborrheic dermatitis
  • psoriarsis
  • temporarity relieves external anal and genital itching
  • other uses of this product should be only under the advice and supervision of a doctor
Purpose

Anti-Itch

Warnings

For external use only

Jar Label

NDC 73141-622-54

Hydrocortisone Cream 1%

Maximum Strength Anti-Itch Cream

NET WT 1LB (454g)

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: do not use, ask a doctor
  • for external anal and genital itching, adults:
  • when practical, cleanse 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.
Carton Label

NDC 73141-622-28

Hydrocortisone Cream 1%

Maximum Strength Anti-Itch Cream

NET WT 1 OZ (28g)

Active Ingredient (Active ingredient)

Hydrocortisone 1%

Other Information (Other information)
  • store at 20-25°C (68-77°F)
Inactive Ingredients (Inactive ingredients)

Cetyl alcohol, glycerin, glyceryl stearate SE, mineral oil, PEG-100 stearate, phenoxyethanol, purified water, stearyl alcohol, white petrolatum, xanthan gum

Questions Or Comments? (Questions or comments?)

Call 1(800)380-6709

Distributed By:

A2A Integrated Pharmaceuticals

Bowling Green, KY 42101

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)
  • rectal bleeding occurs
  • condition worsens, symptoms persist for more than 7 days or clear up and occur again within a few days, and do not use this or any other hydrocortisone product unless you have asked 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 immediately. (1-800-222-1222)


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