Zoryve

ZORYVE® is for use on the skin (topical 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 it 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 when applying and right after you apply it.

The most common side effects of ZORYVE cream 0.3% 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% for atopic dermatitis include:

• headache

• nausea

• application site pain

• diarrhea

• vomiting

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

• common cold

• nausea

• headache
  

These are not all of the possible side effects of ZORYVE. Call your healthcare provider for medical advice about side effects. You are encouraged to 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 people 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 people 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 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 under 9 years of age.

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