Cortizone-10 Soothing Aloe Creme

Cortizone-10 Soothing Aloe Creme
SPL v2
SPL
SPL Set ID 1a841bf0-9d7b-4566-b442-aa9bcc827846
Route
TOPICAL
Published
Effective Date 2023-11-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrocortisone (1 g)
Inactive Ingredients
Aloe Vera Leaf Aluminum Sulfate Yellow Wax Calcium Acetate Cetostearyl Alcohol Glycerin Maltodextrin Methylparaben Mineral Oil Petrolatum Propylparaben Sodium Cetostearyl Sulfate Sodium Lauryl Sulfate Water

Identifiers & Packaging

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

Description

Cortizone- 10   Cre me with Aloe Drug Facts

Purpose

Anti-itch


Medication Information

Purpose

Anti-itch

Description

Cortizone- 10   Cre me with Aloe Drug Facts

In

aloe barbadensis leaf juice, aluminum sulfate, beeswax, calcium acetate, cetearyl alcohol, dextrin, glycerin, maltodextrin, methylparaben, mineral oil, petrolatum, propylparaben, sodium cetearyl sulfate, sodium lauryl sulfate, water

Use

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 only be under the advice and supervision of a doctor

Active

Hydrocortisone 1%

Section 42229-5

Cortizone- 10   Cre me with Aloe

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.

Principal Display Panel

MA X IMUM STRENGTH

Cortizone - 10

SOOT HING ALOE CRÈME

1% Hydrocortisone Anti-Itch Crème


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

In

aloe barbadensis leaf juice, aluminum sulfate, beeswax, calcium acetate, cetearyl alcohol, dextrin, glycerin, maltodextrin, methylparaben, mineral oil, petrolatum, propylparaben, sodium cetearyl sulfate, sodium lauryl sulfate, water

Use

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 only be under the advice and supervision of a doctor

Active

Hydrocortisone 1%

Section 42229-5 (42229-5)

Cortizone- 10   Cre me with Aloe

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.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

MA X IMUM STRENGTH

Cortizone - 10

SOOT HING ALOE CRÈME

1% Hydrocortisone Anti-Itch Crème


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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