Cortizone 10 Ultra Soothing Creme

Cortizone 10 Ultra Soothing Creme
SPL v2
SPL
SPL Set ID 4b62615f-e713-42f2-8b9c-9eebf8d1b270
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
Water Cetostearyl Alcohol Glycerin Petrolatum Mineral Oil Isopropyl Palmitate Sodium Lauryl Sulfate Yellow Wax Sodium Cetostearyl Sulfate Methylparaben .alpha.-tocopherol Acetate Propylparaben Propylene Glycol Cetyl Alcohol Aluminum Sulfate Calcium Acetate Corn Oil Cholecalciferol Vitamin A Palmitate Aloe Vera Leaf Maltodextrin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-01-01

Description

Cortizone 10 Ultra Soothing Creme Drug Facts

Purpose

Anti-itch


Medication Information

Purpose

Anti-itch

Description

Cortizone 10 Ultra Soothing Creme Drug Facts

Use

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

  eczema  psoriasispoison ivy, oak, sumac  insect bites  detergents  jewelry   cosmetics

    soaps  seborrheic dermatitis

 temporarily relieves external anal and genital itching

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

Section 42229-5

Cortizone 10 Ultra Soothing Creme

Drug Facts

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: 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. Consult a doctor. ■ for the treatment of diaper rash. Consult a doctor.

Active Ingredient

Hydrocortisone1%

Inactive Ingredients

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 (309-071)

Principal Display Panel

Cortizone 10

ULTRA SOOTHING CREME

1% Hydrocortisone

Anti-itch Creme

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

Use

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

  eczema  psoriasispoison ivy, oak, sumac  insect bites  detergents  jewelry   cosmetics

    soaps  seborrheic dermatitis

 temporarily relieves external anal and genital itching

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

Section 42229-5 (42229-5)

Cortizone 10 Ultra Soothing Creme

Drug Facts

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: 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. Consult a doctor. ■ for the treatment of diaper rash. Consult a doctor.

Active Ingredient (Active ingredient)

Hydrocortisone1%

Inactive Ingredients (Inactive ingredients)

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 (309-071)

Principal Display Panel

Cortizone 10

ULTRA SOOTHING CREME

1% Hydrocortisone

Anti-itch Creme

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.


Advanced Ingredient Data


Raw Label Data

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