EUCRISA Full Patient Information

(crisaborole)

Full Patient Information

17 PATIENT COUNSELING INFORMATION

Advise the patient or caregivers to read the FDA-approved patient labeling (Patient Information).

Hypersensitivity Reactions

Advise patients to discontinue EUCRISA and seek medical attention immediately if signs or symptoms of hypersensitivity occur [see Warnings and Precautions (5.1)].

Administration Instructions

Advise patients or caregivers that EUCRISA is for topical use only and is not for ophthalmic, oral, or intravaginal use.

This Patient Information has been approved by the U.S. Food and Drug Administration.		Revised: 4/2023
PATIENT INFORMATION EUCRISA (you-KRIS-a) (crisaborole) ointment
Important information: EUCRISA is for use on skin (topical use) only. Do not use EUCRISA in your eyes, mouth, or vagina.
What is EUCRISA? EUCRISA is a prescription medicine used on the skin (topical) to treat mild to moderate eczema (atopic dermatitis) in adults and children 3 months of age and older. It is not known if EUCRISA is safe and effective in children under 3 months of age.
Who should not use EUCRISA? Do not use EUCRISA if you are allergic to crisaborole or any of the ingredients in EUCRISA. See the end of this Patient Information leaflet for a complete list of ingredients in EUCRISA.
Before using EUCRISA, tell your healthcare provider about all of your medical conditions, including if you: • are pregnant or plan to become pregnant. It is not known if EUCRISA will harm your unborn baby. • are breastfeeding or plan to breastfeed. It is not known if EUCRISA passes into your breast milk. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
How should I use EUCRISA? • Use EUCRISA exactly as your healthcare provider tells you to use it. • Apply a thin layer of EUCRISA to the affected areas 2 times each day or as directed by your healthcare provider. • Wash your hands after applying EUCRISA, unless hands are being treated. If someone else applies EUCRISA for you, they should wash their hands after applying EUCRISA.
What are the possible side effects of EUCRISA? EUCRISA may cause side effects. • Allergic reactions. EUCRISA may cause allergic reactions at or near the application site or at a distant site which may be serious. Stop using EUCRISA and get medical help right away if you have any symptoms of an allergic reaction including:
o trouble breathing or throat tightness	o hives
o chest tightness	o itching
o feeling faint o swelling of your face, eyelids, lips, mouth, tongue or throat	o redness
The most common side effect of EUCRISA is application site pain, such as burning or stinging. This is not the only possible side effect of EUCRISA. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store EUCRISA? • Store EUCRISA at room temperature, between 68°F to 77°F (20°C to 25°C). • Keep the tube tightly closed. Keep EUCRISA and all medicines out of the reach of children.
General information about the safe and effective use of EUCRISA Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use EUCRISA for a condition for which it was not prescribed. Do not give EUCRISA to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about EUCRISA that is written for healthcare professionals.
What are the ingredients in EUCRISA? Active ingredient: crisaborole Inactive ingredients: white petrolatum, propylene glycol, mono- and di-glycerides, paraffin, butylated hydroxytoluene, and edetate calcium disodium. LAB-0917-5.0 For more information, call 1-866-EUCRISA [1-866-382-7472] or go to www.EUCRISA.com

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EUCRISA Quick Finder

Medication Guide

Health Professional Information

Full Patient Information

17 PATIENT COUNSELING INFORMATION

Advise the patient or caregivers to read the FDA-approved patient labeling (Patient Information).

Hypersensitivity Reactions

Advise patients to discontinue EUCRISA and seek medical attention immediately if signs or symptoms of hypersensitivity occur [see Warnings and Precautions (5.1)].

Administration Instructions

Advise patients or caregivers that EUCRISA is for topical use only and is not for ophthalmic, oral, or intravaginal use.

This Patient Information has been approved by the U.S. Food and Drug Administration.		Revised: 4/2023
PATIENT INFORMATION EUCRISA (you-KRIS-a) (crisaborole) ointment
Important information: EUCRISA is for use on skin (topical use) only. Do not use EUCRISA in your eyes, mouth, or vagina.
What is EUCRISA? EUCRISA is a prescription medicine used on the skin (topical) to treat mild to moderate eczema (atopic dermatitis) in adults and children 3 months of age and older. It is not known if EUCRISA is safe and effective in children under 3 months of age.
Who should not use EUCRISA? Do not use EUCRISA if you are allergic to crisaborole or any of the ingredients in EUCRISA. See the end of this Patient Information leaflet for a complete list of ingredients in EUCRISA.
Before using EUCRISA, tell your healthcare provider about all of your medical conditions, including if you: • are pregnant or plan to become pregnant. It is not known if EUCRISA will harm your unborn baby. • are breastfeeding or plan to breastfeed. It is not known if EUCRISA passes into your breast milk. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
How should I use EUCRISA? • Use EUCRISA exactly as your healthcare provider tells you to use it. • Apply a thin layer of EUCRISA to the affected areas 2 times each day or as directed by your healthcare provider. • Wash your hands after applying EUCRISA, unless hands are being treated. If someone else applies EUCRISA for you, they should wash their hands after applying EUCRISA.
What are the possible side effects of EUCRISA? EUCRISA may cause side effects. • Allergic reactions. EUCRISA may cause allergic reactions at or near the application site or at a distant site which may be serious. Stop using EUCRISA and get medical help right away if you have any symptoms of an allergic reaction including:
o trouble breathing or throat tightness	o hives
o chest tightness	o itching
o feeling faint o swelling of your face, eyelids, lips, mouth, tongue or throat	o redness
The most common side effect of EUCRISA is application site pain, such as burning or stinging. This is not the only possible side effect of EUCRISA. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store EUCRISA? • Store EUCRISA at room temperature, between 68°F to 77°F (20°C to 25°C). • Keep the tube tightly closed. Keep EUCRISA and all medicines out of the reach of children.
General information about the safe and effective use of EUCRISA Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use EUCRISA for a condition for which it was not prescribed. Do not give EUCRISA to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about EUCRISA that is written for healthcare professionals.
What are the ingredients in EUCRISA? Active ingredient: crisaborole Inactive ingredients: white petrolatum, propylene glycol, mono- and di-glycerides, paraffin, butylated hydroxytoluene, and edetate calcium disodium. LAB-0917-5.0 For more information, call 1-866-EUCRISA [1-866-382-7472] or go to www.EUCRISA.com

Prescribing Information

Download Prescribing Information

Health Professional Information

Full Patient Information

17 PATIENT COUNSELING INFORMATION

Advise the patient or caregivers to read the FDA-approved patient labeling (Patient Information).

Hypersensitivity Reactions

Advise patients to discontinue EUCRISA and seek medical attention immediately if signs or symptoms of hypersensitivity occur [see Warnings and Precautions (5.1)].

Administration Instructions

Advise patients or caregivers that EUCRISA is for topical use only and is not for ophthalmic, oral, or intravaginal use.

This Patient Information has been approved by the U.S. Food and Drug Administration.		Revised: 4/2023
PATIENT INFORMATION EUCRISA (you-KRIS-a) (crisaborole) ointment
Important information: EUCRISA is for use on skin (topical use) only. Do not use EUCRISA in your eyes, mouth, or vagina.
What is EUCRISA? EUCRISA is a prescription medicine used on the skin (topical) to treat mild to moderate eczema (atopic dermatitis) in adults and children 3 months of age and older. It is not known if EUCRISA is safe and effective in children under 3 months of age.
Who should not use EUCRISA? Do not use EUCRISA if you are allergic to crisaborole or any of the ingredients in EUCRISA. See the end of this Patient Information leaflet for a complete list of ingredients in EUCRISA.
Before using EUCRISA, tell your healthcare provider about all of your medical conditions, including if you: • are pregnant or plan to become pregnant. It is not known if EUCRISA will harm your unborn baby. • are breastfeeding or plan to breastfeed. It is not known if EUCRISA passes into your breast milk. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
How should I use EUCRISA? • Use EUCRISA exactly as your healthcare provider tells you to use it. • Apply a thin layer of EUCRISA to the affected areas 2 times each day or as directed by your healthcare provider. • Wash your hands after applying EUCRISA, unless hands are being treated. If someone else applies EUCRISA for you, they should wash their hands after applying EUCRISA.
What are the possible side effects of EUCRISA? EUCRISA may cause side effects. • Allergic reactions. EUCRISA may cause allergic reactions at or near the application site or at a distant site which may be serious. Stop using EUCRISA and get medical help right away if you have any symptoms of an allergic reaction including:
o trouble breathing or throat tightness	o hives
o chest tightness	o itching
o feeling faint o swelling of your face, eyelids, lips, mouth, tongue or throat	o redness
The most common side effect of EUCRISA is application site pain, such as burning or stinging. This is not the only possible side effect of EUCRISA. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store EUCRISA? • Store EUCRISA at room temperature, between 68°F to 77°F (20°C to 25°C). • Keep the tube tightly closed. Keep EUCRISA and all medicines out of the reach of children.
General information about the safe and effective use of EUCRISA Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use EUCRISA for a condition for which it was not prescribed. Do not give EUCRISA to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about EUCRISA that is written for healthcare professionals.
What are the ingredients in EUCRISA? Active ingredient: crisaborole Inactive ingredients: white petrolatum, propylene glycol, mono- and di-glycerides, paraffin, butylated hydroxytoluene, and edetate calcium disodium. LAB-0917-5.0 For more information, call 1-866-EUCRISA [1-866-382-7472] or go to www.EUCRISA.com

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