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Zoryve (roflumilast) cream 0.3% Cream

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Description

Indications and Usage:

ZORYVE™ is indicated for topical treatment of plaque psoriasis, including intertriginous areas, in patients 12 years of age and older.

Product Properties:

Description S
Description -
DESI Drug Ind -
DESI Drug Ind -; -
DESI2 Drug Ind NR
Drug Category USES: This medication is used to treat plaque psoriasis.
Drug Category -
Drug Type Code COMMON BRAND NAME(S): Zoryve
Drug Type Code S
FDA Approval Date 08/08/2022
FDA Therap Equiv GM
HCPCS -
HCPCS 1
Market Entry Date -
Medical Coverage -
Medical Coverage -
Termination Date (roe-FLUE-mi-last)
Termination Date 1
Unit 60
Units Per Pkg 07/29/2022
Active Ingredients 13499 roflumilast 162401323
Active Ingredients 13499 roflumilast 162401323
AHFS Class 84920000 SKIN AND MUCOUS MEMBRANE AGENTS, MISC.
AHFS Class 84920000 SKIN AND MUCOUS MEMBRANE AGENTS, MISC.
DEA Class NC
DEA Class NC
Dose Form CREAM (GRAM)
Dose Form CREAM (GRAM)
Fine Line Class 850085008510 All Rx Products
Fine Line Class 850085008510 All Rx Products
Gen Code and Des 83653 roflumilast TOPICAL CREAM (G) 0.3 %
Gen Code and Des 83653 roflumilast TOPICAL CREAM (G) 0.3 %
Inactive Ingredients 3203 paraben 99967
Inactive Ingredients 3203 paraben 99967
OMP Family -
OMP Family -
Product Category RX Pharmaceuticals
Product Category RX Pharmaceuticals
Strength 0.3%
Strength 0.3%
Common Brand Name -
Common Brand Name COMMON BRAND NAME(S): Zoryve
Drug Interaction -
Drug Interaction DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.
Allocation Period -
Allocation Period -
Case Quantity 40
Case Quantity 40
Drug Form Pack Size 60
Drug Form Pack Size 60
Form CREAM
Form CREAM
Hazard Code -
Hazard Code -
Listed Chemical -
Listed Chemical -
NIOSH Code -
NIOSH Code -
Orange Book ZC Pharmaceutical entity and labeler evaluated but no therapeutic equivalence rating given. Usually applies to single source drugs.
Orange Book ZC Pharmaceutical entity and labeler evaluated but no therapeutic equivalence rating given. Usually applies to single source drugs.
Retail Pack Quantity 1
Retail Pack Quantity 1
Returnable Status Returnable
Returnable Status Returnable
Special Storage Cond 00 None
Special Storage Cond 00 None
Temp Zone 10 Room Temperature
Temp Zone 10 Room Temperature
Unit EA
Unit EA
Unit Size 60
Unit Size 60
How to Use -
How to Use HOW TO USE: Read the Patient Information Leaflet if available from your pharmacist before you start using roflumilast and each time you get a refill. If you have any questions, ask your doctor or pharmacist. This medication is for use on the skin only. Apply this medication to the affected area and rub in completely as directed by your doctor, usually once daily. Wash your hands after applying, unless you are treating your hands. Avoid getting this medication in your eyes, mouth, or vagina. If this happens, rinse right away with plenty of water. Use this medication regularly to get the most benefit from it. To help you remember, use it at the same time each day. Tell your doctor if your condition does not get better or if it gets worse.
Missed Dose MISSED DOSE: If you miss a dose, apply it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Apply your next dose at the regular time. Do not apply extra medicine to make up for the missed dose.
Missed Dose 60
Notes GM
Notes NOTES: Do not share this medication with others.
Overdose OVERDOSE: This medicine may be harmful if swallowed. If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
Overdose NR
Phonetic Pronunciation -
Phonetic Pronunciation (roe-FLUE-mi-last)
Precautions -
Precautions PRECAUTIONS: Before using roflumilast, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease. Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. It is unknown if this drug passes into breast milk. To avoid direct contact, do not apply this medication to the nipple and areola if breast-feeding. Consult your doctor before breast-feeding.
Side Effects SIDE EFFECTS: Diarrhea, nausea, headache, or pain at the application site may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly. Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Tell your doctor right away if you have any serious side effects, including: trouble sleeping, signs of infection (such as sore throat that doesn't go away, fever, chills). A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, severe itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Side Effects -
Storage 07/29/2022
Storage STORAGE: Store at room temperature. Keep all medications away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
Uses USES: This medication is used to treat plaque psoriasis.
Uses -

Frequently Asked Questions(FAQs)

The cost of Zoryve (roflumilast) cream 0.3% Cream is available for registerd members only .
Zoryve (roflumilast) cream 0.3% Cream is manufactured by ARCUTIS BIOTHERAPEUTICS, INC.
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