Cortizone 10 Ultra Soothing Itch Relief Cream

Cortizone 10 Ultra Soothing Itch Relief Cream
SPL v1
SPL
SPL Set ID 8a9e2d32-a65f-4253-8041-4146f4e3b738
Route
TOPICAL
Published
Effective Date 2025-02-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrocortisone (1 g)
Inactive Ingredients
Water Cetearyl Alcohol Glycerin Petrolatum Mineral Oil Isopropyl Palmitate Sodium Lauryl Sulfate Beeswax Sodium Cetearyl Sulfate Methylparaben Alpha-tocopherol Acetate Propylparaben Propylene Glycol Cetyl Alcohol Aluminum Sulfate Calcium Acetate Dextrin, Potato Zea Mays (corn) Oil Cholecalciferol Retinyl Palmitate Aloe Vera Leaf Maltodextrin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-02-01

Description

Cortizone 10   Ultra Soothing Itch Relief Cream Drug Facts

Purpose

Anti-Itch


Medication Information

Purpose

Anti-Itch

Description

Cortizone 10   Ultra Soothing Itch Relief Cream Drug Facts

D

■ 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 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

Uses

for the temporary relief of 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

Inactive

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

Warnings

For external use only .

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.

     

Cortizone 10   Ultra Soothing Itch Relief Cream

Drug Facts

Active Ingredients

Hydrocortisone 1%

Principal Display Panel

MAXIMUM STRENGTH

Cortizone 10

ULTRA SOOTHING

ITCH RELIEF

CREAM

1% Hydrocortisone

Anti-Itch Cream

Net wt 1 oz (28 g)

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 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

■ rectal bleeding occurs

Keep Out of Reach of Children.

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


Structured Label Content

D

■ 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 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

Uses

for the temporary relief of 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

Inactive

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

Warnings

For external use only .

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.

     

Cortizone 10   Ultra Soothing Itch Relief Cream

Drug Facts

Active Ingredients (Active ingredients)

Hydrocortisone 1%

Principal Display Panel

MAXIMUM STRENGTH

Cortizone 10

ULTRA SOOTHING

ITCH RELIEF

CREAM

1% Hydrocortisone

Anti-Itch Cream

Net wt 1 oz (28 g)

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 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

■ 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.


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Raw Label Data

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