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

Purpose

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

Description

Cortizone 10 Itch Relief Massaging Rollerball Drug Facts


Medication Information

Warnings

For external use only

Purpose

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

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

Description

Cortizone 10 Itch Relief Massaging Rollerball Drug Facts

Principal Display Panel

Cortizone 10

Itch Relief

Massaging Rollerball 1.5 FL OZ (44.3 mL)

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

When Using This

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

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

Warnings

For external use only

Purpose

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

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

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Cortizone 10

Itch Relief

Massaging Rollerball 1.5 FL OZ (44.3 mL)

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

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

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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