vusion
Pharmaranks rates Vusion 3.3/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Vusion is a combination medicine containing Miconazole Nitrate, White Petrolatum, and Zinc Oxide.
Miconazole Nitrate and White Petrolatum and Zinc Oxide · by Mylan
Based on 1 source · Recall-safety score from FDA recall history — this product's own recalls and its manufacturer's record. Not an efficacy or quality rating. methodology →
Key facts
What is Vusion?
From the FDA label:Miconazole nitrate, zinc oxide and white petrolatum ointment contains the synthetic antifungal agent, miconazole nitrate (0.25%) USP, zinc oxide (15%) USP, and white petrolatum (81.35%) USP. The chemical name of miconazole nitrate is 1-[2, 4-dichloro-ß-{(2,4-dichlorobenzyl)oxy} phenethyl] imidazole mononitrate with empirical formula C 18 H 14 Cl 4 N 2 O•HNO 3 and molecular weight of 479.15. The structural formula of miconazole nitrate is as follows: The zinc oxide has an empirical formula of ZnO and a molecular weight of 81.39. The white petrolatum, which is obtained from petroleum and is wholly or nearly decolorized, is a purified mixture of semisolid saturated hydrocarbons having the general chemical formula C n H 2n+2 . The hydrocarbons consist mainly of branched and unbranched chains. White petrolatum contains butylated hydroxytoluene (BHT) as stabilizer. Each gram of miconazole nitrate, zinc oxide and white petrolatum ointment contains 2.5 mg of miconazole nitrate, USP, 150 mg of zinc oxide, USP and 813.5 mg of white petrolatum, USP containing butylated hydroxytoluene, trihydroxystearin, and Chemoderm 1001/B fragrance. Miconazole nitrate, zinc oxide and white petrolatum ointment is a smooth, uniform, white ointment. Miconazole Nitrate Structural Formula
How to use
Miconazole nitrate, zinc oxide and white petrolatum ointment is not for oral, ophthalmic, or intravaginal use. Before applying miconazole nitrate, zinc oxide and white petrolatum ointment, gently cleanse the skin with lukewarm water and pat dry with a soft towel. Avoid using any scented soaps, shampoos, or lotions on the diaper area. Gently apply a thin layer of miconazole nitrate, zinc oxide and white petrolatum ointment to the diaper area with each diaper change for 7 days. Do not rub miconazole nitrate, zinc oxide and white petrolatum ointment into the skin as this may cause additional irritation. Thoroughly wash hands after applying miconazole nitrate, zinc oxide and white petrolatum ointment. Continue treatment for the full 7 days, even if there is improvement. Do not use miconazole nitrate, zinc oxide and white petrolatum ointment for longer than 7 days. The safety of miconazole nitrate, zinc oxide and white petrolatum ointment when used for longer than 7 days is not known. If symptoms have not improved by day 7, see your health care provider. • Miconazole nitrate, zinc oxide and white petrolatum ointment is for topical use only. Miconazole nitrate, zinc oxide and white petrolatum ointment is not for oral, ophthalmic, or intravaginal use. ( 2 ) • Miconazole nitrate, zinc oxide and white petrolatum ointment should be applied as a thin layer to the affected area at each…
Side effects
To report SUSPECTED ADVERSE REACTIONS, contact Mylan at 1-877-446-3679 (1-877-4-INFO-RX) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rate observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. A total of 835 infants and young children were evaluated in the clinical development program. Of 418 subjects in the miconazole nitrate, zinc oxide and white petrolatum ointment group, 58 (14%) reported one or more adverse events. Of 417 subjects in the zinc oxide/white petrolatum control group, 85 (20%) reported one or more adverse events. Adverse events that occurred at a rate of ≥ 1% for subjects who were treated with miconazole nitrate, zinc oxide and white petrolatum ointment were approximately the same in type and frequency as for subjects who were treated with zinc oxide/white petrolatum ointment. 6.2 Post-marketing Experience The following adverse reactions have been identified during post approval use of miconazole nitrate, zinc oxide and white petrolatum ointment. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal…
Warnings
Important safety information
If irritation occurs or if the disease worsens, discontinue use of the medication, and contact the health care provider. ( 5.1 ) 5.1 Skin Irritation If irritation occurs or if the disease worsens, discontinue use of the medication, and contact the health care provider.
Who should not take Vusion
None • None
Interactions
Drug-drug interaction studies were not conducted. Women who take a warfarin anticoagulant and use a miconazole intravaginal cream or suppository may be at risk for developing an increased prothrombin time, international normalized ratio (INR), and bleeding. The potential for this interaction between warfarin and miconazole nitrate, zinc oxide and white petrolatum ointment is unknown.
Dosage forms
Topical
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
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Request a 90-day supply
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Use copay cards
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Frequently asked questions
- How is Vusion rated?
- pharmaranks gives Vusion a composite score of 3.3 out of 5, currently based on 1 weighted source (FDA regulatory recall-safety data weighted highest). See our methodology at /how-we-rate.
- Is there a coupon or discount for Vusion?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Vusion. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Vusion?
- Vusion is marketed by Mylan. You can see Mylan's full profile, rating, and other products on pharmaranks.
- Is Vusion a brand-name or generic drug?
- Vusion is a brand-name product with the active ingredient Miconazole Nitrate and White Petrolatum and Zinc Oxide.
- Is Vusion available over the counter?
- No. Vusion is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Vusion come in?
- Vusion is currently marketed as topical, per the FDA's National Drug Code Directory.
- Is Vusion FDA-registered?
- Vusion is on record with the U.S. FDA under application number NDA021026. You can verify this on its official FDA label.
- Has Vusion been recalled by the FDA?
- Vusion has no FDA recalls recorded under its own application in the openFDA enforcement database. Its recall-safety score reflects its manufacturer's overall recall record. This is general reference, not medical advice — check the FDA recall database for the latest alerts.
- Is Vusion safe?
- There's no single safe-or-not verdict. pharmaranks gives Vusion a recall-safety score of 66/100, based on its FDA recall history (no recalls under its own FDA application) — not an efficacy or side-effect rating. Review its FDA-label side effects and warnings before use, and always consult a licensed professional.
- What are the side effects of Vusion?
- Vusion's side effects are taken directly from its FDA label. From the label: To report SUSPECTED ADVERSE REACTIONS, contact Mylan at 1-877-446-3679 (1-877-4-INFO-RX) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions,… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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vusion
66/100