Cortizone 10 Itch Relief Massaging Rollerball

Cortizone 10 Itch Relief Massaging Rollerball
SPL v4
SPL
SPL Set ID 1e27682c-f856-41f1-9935-37540960a4c7
Route
TOPICAL
Published
Effective Date 2024-05-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrocortisone (1 g)
Inactive Ingredients
Water Alcohol Dimethicone Caprylyl Trisiloxane Cetostearyl Alcohol Ceteth-20 Phosphate Hydroxyethyl Acrylate/sodium Acryloyldimethyl Taurate Copolymer (100000 Mpa.s At 1.5%) Glycerin Ethylhexylglycerin Aloe Vera Leaf Hydroxyacetophenone Glyceryl Monostearate C30-45 Alkyl Cetearyl Dimethicone Crosspolymer Isohexadecane Dihexadecyl Phosphate Aminomethylpropanol Steareth-2 Steareth-21 Polysorbate 60 Edetate Disodium Anhydrous Citric Acid Monohydrate Carbomer Copolymer Type A

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-01-02

Description

Cortizone 10 Itch Relief Massaging Rollerball Drug Facts

Purpose

Hydrocortisone 1%...........................................................................................................................................Anti-itch


Medication Information

Purpose

Hydrocortisone 1%...........................................................................................................................................Anti-itch

Description

Cortizone 10 Itch Relief Massaging Rollerball Drug Facts

In

water, alcohol denat. (15%), dimethicone, caprylyl methicone, cetearyl alcohol, ceteth-20 phosphate, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, glycerin, ethylhexylglycerin, aloe barbadensis leaf juice, hydroxyacetophenone, glyceryl stearate, C30-45 alkyl cetearyl dimethicone crosspolymer, isohexadecane, acrylates/C10-30 alkyl acrylate crosspolymer, dicetyl phosphate, aminomethyl propanol, steareth-2, steareth-21, polysorbate 60, disodium EDTA, citric acid

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

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

Do Not

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

■ if you are allergic to any ingredient in this product

Section 42229-5

Cortizone 10 Itch Relief Massaging Rollerball

Drug Facts

Warnings

For external use only

Directions

■ 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

When Using This

 avoid contact with the eyes ■ do not use more than directed unless told to do so by a doctor

Principal Display Panel

Cortizone 10

Itch Relief

Massaging Rollerball 1.5 FL OZ (44.3 mL)

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, do not use this or 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

In

water, alcohol denat. (15%), dimethicone, caprylyl methicone, cetearyl alcohol, ceteth-20 phosphate, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, glycerin, ethylhexylglycerin, aloe barbadensis leaf juice, hydroxyacetophenone, glyceryl stearate, C30-45 alkyl cetearyl dimethicone crosspolymer, isohexadecane, acrylates/C10-30 alkyl acrylate crosspolymer, dicetyl phosphate, aminomethyl propanol, steareth-2, steareth-21, polysorbate 60, disodium EDTA, citric acid

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

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

Do Not (Do not)

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

■ if you are allergic to any ingredient in this product

Section 42229-5 (42229-5)

Cortizone 10 Itch Relief Massaging Rollerball

Drug Facts

Purpose

Hydrocortisone 1%...........................................................................................................................................Anti-itch

Warnings

For external use only

Directions

■ 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

When Using This (When using this)

 avoid contact with the eyes ■ do not use more than directed unless told to do so by a doctor

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Cortizone 10

Itch Relief

Massaging Rollerball 1.5 FL OZ (44.3 mL)

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, do not use this or 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.


Advanced Ingredient Data


Raw Label Data

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