Sam’s West, Inc. Hydrocortisone 1% Plus Drug Facts

Sam’s West, Inc. Hydrocortisone 1% Plus Drug Facts
SPL v4
SPL
SPL Set ID 218f0dcd-fa67-4935-8019-ecbbd53ed2f7
Route
TOPICAL
Published
Effective Date 2024-09-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrocortisone (1 g)
Inactive Ingredients
Aloe Vera Leaf Aluminum Sulfate Calcium Acetate Cetostearyl Alcohol Cetyl Alcohol Cholecalciferol Icodextrin Glycerin Isopropyl Palmitate Light Mineral Oil Maltodextrin Methylparaben Propylene Glycol Propylparaben Water Vitamin A Palmitate Sodium Cetostearyl Sulfate Sodium Lauryl Sulfate Tocopherol Petrolatum White Wax Corn Oil

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-05-30

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
  • detergents
  • jewelry
  • cosmetics
  • soaps
  • seborrheic dermatitis
  • temporarily 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

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, clean the affected area with mild soap and warm water and rinse thoroughly
  • gently dry by patting or blotting with toilet tissue or a 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. Ask a doctor.
  • for the treatment of diaper rash. Ask a doctor.
Active Ingredient

Hydrocortisone 1%

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

aloe barbadensis leaf juice, aluminum sulfate, calcium acetate, cetearyl alcohol, cetyl alcohol, cholecalciferol, dextrin, glycerin, isopropyl palmitate, light mineral oil, maltodextrin, methylparaben, propylene glycol, propylparaben, purified water, retinyl palmitate, sodium cetearyl sulfate, sodium lauryl sulfate, tocopherol, white petrolatum, white wax, zea mays (corn) oil

Questions Or Comments?

1-800-809-0469

Principal Display Panel

Member’s Mark

COMPARE TO CORTIZONE•10® PLUS ACTIVE INGREDIENT

MAXIMUM STRENGTH

Hydrocortisone 1% Plus

ANTI-ITCH CREAM

Fast Itch Relief | PLUS 10 MOISTURIZERS

ULTRA MOISTURIZING ITCH RELIEF

•ECZEMA & PSORIASIS

•SKIN IRRITATIONS

•DRY, ITCHY SKIN

•INFLAMMATION & REDNESS

4 -2 OZ (56g) TUBES, TOTAL 8 OZ (224g)

When Using This Product
  • avoid contact with the 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
  • rectal bleeding occurs
  • symptoms persist 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
Keep Out of Reach of Children.

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


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
  • detergents
  • jewelry
  • cosmetics
  • soaps
  • seborrheic dermatitis
  • temporarily 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

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, clean the affected area with mild soap and warm water and rinse thoroughly
  • gently dry by patting or blotting with toilet tissue or a 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. Ask a doctor.
  • for the treatment of diaper rash. Ask a doctor.
Active Ingredient (Active ingredient)

Hydrocortisone 1%

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

aloe barbadensis leaf juice, aluminum sulfate, calcium acetate, cetearyl alcohol, cetyl alcohol, cholecalciferol, dextrin, glycerin, isopropyl palmitate, light mineral oil, maltodextrin, methylparaben, propylene glycol, propylparaben, purified water, retinyl palmitate, sodium cetearyl sulfate, sodium lauryl sulfate, tocopherol, white petrolatum, white wax, zea mays (corn) oil

Questions Or Comments? (Questions or comments?)

1-800-809-0469

Principal Display Panel

Member’s Mark

COMPARE TO CORTIZONE•10® PLUS ACTIVE INGREDIENT

MAXIMUM STRENGTH

Hydrocortisone 1% Plus

ANTI-ITCH CREAM

Fast Itch Relief | PLUS 10 MOISTURIZERS

ULTRA MOISTURIZING ITCH RELIEF

•ECZEMA & PSORIASIS

•SKIN IRRITATIONS

•DRY, ITCHY SKIN

•INFLAMMATION & REDNESS

4 -2 OZ (56g) TUBES, TOTAL 8 OZ (224g)

When Using This Product (When using this product)
  • avoid contact with the 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
  • rectal bleeding occurs
  • symptoms persist 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
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.


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