Website feedback | ZORYVE® (roflumilast)

Cream 0.05% and 0.15% for mild to
moderate eczema (atopic dermatitis)Foam 0.3% for seborrheic dermatitis
and plaque psoriasis Cream 0.3% for plaque psoriasis

Instructions for Use
for ZORYVE foam 0.3%

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PHARMACY LOCATOR

Mild to moderate eczema (atopic dermatitis)Seborrheic dermatitis Plaque psoriasis

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IMPORTANT SAFETY INFORMATION AND APPROVED USES

ZORYVE is for use on the skin (topical use) only. Do not use ZORYVE in or on your eyes, mouth, or vagina. Do not use ZORYVE if you have certain liver problems.

Before using ZORYVE, tell your healthcare provider about all of your medical conditions, including if you:

have liver problems.
are pregnant or plan to become pregnant. It is not known if ZORYVE will harm your unborn baby.
are breastfeeding or plan to breastfeed. It is not known if ZORYVE passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment with ZORYVE. Breastfeeding women using ZORYVE should use it on the smallest area of the skin and for the shortest time needed. Do not apply ZORYVE directly to the nipple or areola to avoid contact with your baby. Avoid direct skin contact of treated areas with your baby if ZORYVE is applied to your chest.

Tell your healthcare provider about the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

What should I avoid while using ZORYVE foam?

ZORYVE foam is flammable. Avoid fire, flame, and smoking during and right after you apply ZORYVE.

The most common side effects of ZORYVE cream 0.3% in adults and children 6 years of age and older treated for plaque psoriasis include:

diarrhea
headache
trouble sleeping
nausea
application site pain
upper respiratory tract infections
urinary tract infections (UTIs)

The most common side effects of ZORYVE cream 0.15% in adults and children 6 years of age and older treated for atopic dermatitis include:

headache
nausea
application site pain
diarrhea
vomiting

The most common side effects of ZORYVE cream 0.05% in children 2 to 5 years of age treated for atopic dermatitis include:

upper respiratory tract infections
diarrhea
vomiting
stuffy or runny nose
red or swollen eyes (like “pink eye”)
headache

The most common side effects of ZORYVE foam 0.3% in people treated for seborrheic dermatitis include:

common cold
nausea
headache

The most common side effects of ZORYVE foam 0.3% in people treated for plaque psoriasis include:

headache
diarrhea
nausea
common cold

These are not all of the possible side effects of ZORYVE. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Please see Patient Information for ZORYVE cream and Patient Information for ZORYVE foam.

APPROVED USES

ZORYVE cream 0.3% is a prescription medicine used on the skin (topical), including in areas with skin folds, to treat plaque psoriasis in adults and children 6 years of age and older.

It is not known if ZORYVE cream 0.3% is safe and effective in children with plaque psoriasis under 6 years of age.

ZORYVE cream 0.15% is a prescription medicine used on the skin (topical) to treat mild to moderate eczema (atopic dermatitis) in adults and children 6 years of age and older.

It is not known if ZORYVE cream 0.15% is safe and effective in children with mild to moderate eczema (atopic dermatitis) under 6 years of age.

ZORYVE cream 0.05% is a prescription medicine used on the skin (topical) to treat mild to moderate eczema (atopic dermatitis) in children 2 to 5 years of age.

It is not known if ZORYVE cream 0.05% is safe and effective in children with mild to moderate eczema (atopic dermatitis) under 2 years of age and 6 years of age and older.

ZORYVE foam is a prescription medicine used on the skin (topical) to treat seborrheic dermatitis in adults and children 9 years of age and older.

It is not known if ZORYVE foam is safe and effective in children with seborrheic dermatitis under 9 years of age.

ZORYVE foam is a prescription medicine used on the skin (topical) to treat plaque psoriasis of the scalp and body in adults and children 12 years of age and older.

It is not known if ZORYVE foam is safe and effective in children with plaque psoriasis of the scalp and body under 12 years of age.

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US-COM-PTF-00754 v3 02/26

IMPORTANT SAFETY INFORMATION
AND APPROVED USES

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