Leader Hydrocortisone Cream With Aloe

Leader Hydrocortisone Cream With Aloe
SPL v1
SPL
SPL Set ID 16f2f3cb-4611-5867-e063-6394a90af107
Route
TOPICAL
Published
Effective Date 2024-05-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-04-16

Description

Hydrocortisone 1%

Purpose

Anti-Itch


Medication Information

Purpose

Anti-Itch

Description

Hydrocortisone 1%

Uses

For temporary relief of 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

Section 51945-4

Warnings
  • for external use only
Questions

Call 1-888-296-9067

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, ask a doctor

For external and anal itching

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 applicaiton of this product.

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°-25°C (68°-77°F)
  • Tamper Evident: do not use if the seal on the tube is punctured or not visible.
Inactive Ingredients

Aloe barbadensis leaf juice, 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
  • 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 fingers or 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
  • 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

For temporary relief of 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

Section 51945-4 (51945-4)

Purpose

Anti-Itch

Warnings
  • for external use only
Questions

Call 1-888-296-9067

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, ask a doctor

For external and anal itching

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 applicaiton of this product.

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°-25°C (68°-77°F)
  • Tamper Evident: do not use if the seal on the tube is punctured or not visible.
Inactive Ingredients

Aloe barbadensis leaf juice, 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
  • 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 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 immediately.

Stop Using This Product and Ask A Doctor (Stop using this product and ask a doctor)
  • 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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