Always Save Hydrocortisone Cream 1%

Always Save Hydrocortisone Cream 1%
SPL v1
SPL
SPL Set ID 141aa2a7-8789-1127-e063-6294a90a2d23
Route
TOPICAL
Published
Effective Date 2023-11-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrocortisone (1 g)
Inactive Ingredients
Sorbitan Monostearate Propylene Glycol Mineral Oil Polysorbate 60 Petrolatum Cetyl Alcohol Water Propylparaben Glyceryl Mono And Dipalmitostearate Edetate Disodium Methylparaben

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-02-20

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
  • seborrheic dermatitis
  • psoriasis
  • insect bites
  • poison ivy
  • poison oak
  • poison sumac
  • soaps
  • detergents
  • cosmetics
  • jewelry
  • external feminine, genital and anal itching

Other uses of this product should be only under the advice and supervision of a doctor

Label

Warnings
  • for external use only
Questions

Call 1-800-883-0085

Directions

Adults and children 2 years 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 and anal ithcing

  • adults: When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly or by patting or blotting with toilet tissue or a soft cloth before application of this product.
  • children under 12 years of age with external anal itching, consult a doctor.
Do Not Use
  • For the treatment of diaper rash, consult a doctor
  • For external genital itching if you have a vaginal discharge, consult a doctor
Active Ingredient

Hydrocortisone 1%

Other Information

Store at controlled room temperature 20°C - 25°C (68°F - 77°F).

Inactive Ingredients

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 begin the use of any other hydrocortisone product unless you have consulted a doctor
  • for external genital, feminine and anal itching do not exceed the recommended daily dosage unless directed by a doctor. In case of bleeding, stop use, consult a doctor.
  • Do not put this product into the rectum by using fingersor any mechanical device or applicator.
Keep Out of Reach of Children

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

Stop Using This Product and Ask A Doctor If
  • Conditions worsen
  • Symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and do not begin use of any other hydrocortisone product unless directed by a doctor.

Structured Label Content

Uses

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

  • eczema
  • seborrheic dermatitis
  • psoriasis
  • insect bites
  • poison ivy
  • poison oak
  • poison sumac
  • soaps
  • detergents
  • cosmetics
  • jewelry
  • external feminine, genital and anal itching

Other uses of this product should be only under the advice and supervision of a doctor

Label

Purpose

Anti-Itch

Warnings
  • for external use only
Questions

Call 1-800-883-0085

Directions

Adults and children 2 years 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 and anal ithcing

  • adults: When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly or by patting or blotting with toilet tissue or a soft cloth before application of this product.
  • children under 12 years of age with external anal itching, consult a doctor.
Do Not Use
  • For the treatment of diaper rash, consult a doctor
  • For external genital itching if you have a vaginal discharge, consult a doctor
Active Ingredient

Hydrocortisone 1%

Other Information

Store at controlled room temperature 20°C - 25°C (68°F - 77°F).

Inactive Ingredients

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 begin the use of any other hydrocortisone product unless you have consulted a doctor
  • for external genital, feminine and anal itching do not exceed the recommended daily dosage unless directed by a doctor. In case of bleeding, stop use, consult a doctor.
  • Do not put this product into the rectum by using fingersor 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 immediately.

Stop Using This Product and Ask A Doctor If (Stop Using this product and ask a doctor if)
  • Conditions worsen
  • Symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and do not begin use of any other hydrocortisone product unless directed by a doctor.

Advanced Ingredient Data


Raw Label Data

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