Miconazole-Zinc-Petroleum 0.25-15-81.35% Ointment- 50gm

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

MICONAZOLE/ZINC OXIDE/PETROLATUM - TOPICAL

(mye-KON-a-zole/zink-OX-ide)

COMMON BRAND NAME(S): Vusion

USES: This product is used in children to treat diaper rash with a yeast infection, along with proper cleaning of the diaper area and frequent diaper changes. Miconazole is an azole antifungal that works by preventing the growth of fungus. Zinc oxide and petrolatum work by forming a barrier on the skin to protect it from moisture and irritation. This product should not be used long-term or to prevent diaper rash. Unnecessary use or misuse of this product can lead to its decreased effectiveness.

HOW TO USE: Use this product on the skin only. Wash your hands before and after applying this product. Gently clean the diaper area with warm water and then pat dry. Gently apply a thin layer of this medication to the affected area, usually during each diaper change or as directed by your doctor. Do not rub the medication into the skin or it may cause more irritation. This medication is usually used for 7 days. Do not apply the medication in the eyes, nose, mouth, or inside the vagina. If you do get the medication in those areas, flush with plenty of water. Use this medication regularly for the most benefit. Remember to use it with every diaper change. Continue to use this product for the full length of treatment, even if symptoms disappear after a few days. Stopping the medication too early may result in a return of the infection. Do not use this product for longer than prescribed. Tell the doctor if your child\'s condition persists after 7 days of treatment or if it worsens.

SIDE EFFECTS: Remember that the doctor has prescribed this medication because he or she has judged that the benefit to your child is greater than the risk of side effects. Many people using this medication do not have serious side effects. Tell the doctor right away if this unlikely side effect occurs: increased irritation at the application site. A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, 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.

PRECAUTIONS: Before using this product, tell the doctor or pharmacist if your child is allergic to miconazole, zinc oxide, or petrolatum; or to other azole antifungals (e.g., clotrimazole, ketoconazole); or if your child has 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 the doctor or pharmacist your child\'s medical history. During pregnancy, this medication should be used only when clearly needed. Pregnant women should use caution when applying this medication on their children. Discuss the risks and benefits with your doctor. It is not known whether this drug passes into breast milk. Breast-feeding women should use caution when applying this medication on their children. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: The doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring your child for them. Do not start, stop, or change the dosage of any medicine before checking with the doctor or pharmacist first. Before using this medication, tell the doctor or pharmacist of all prescription and nonprescription/herbal products your child may use. Keep a list of all your child\'s medications with you, and share the list with the doctor and pharmacist.

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.

NOTES: Do not share this medication with others. This medication should be used for your baby\'s current condition only. Do not use it later for another condition unless told to do so by the doctor. A different medication may be necessary in those cases. This product is not meant to replace frequent diaper changes. To help the diaper rash heal and to prevent future diaper rashes, check your baby\'s diaper often, and change the diaper whenever it appears wet/dirty.

MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next diaper change, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store at room temperature between 68-77 degrees F (20-25 degrees C). Brief storage between 59-86 degrees F (15-30 degrees C) is permitted. Keep all medicines 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 for more details about how to safely discard your product.

Information last revised July 2016. Copyright(c) 2016 First Databank, Inc.