NDC 0378-9730 Vusion

Miconazole Nitrate, Zinc Oxide, White Petrolatum

NDC Product Code 0378-9730

NDC CODE: 0378-9730

Proprietary Name: Vusion What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Miconazole Nitrate, Zinc Oxide, White Petrolatum What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Drug Use Information

Drug Use Information
The drug use information 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. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • This medication is used to treat vaginal yeast infections. Miconazole reduces vaginal burning, itching, and discharge that may occur with this condition. This medication is an azole antifungal. It works by stopping the growth of yeast (fungus) that causes the infection. The vaginal product comes in 2 forms (a vaginal cream or tablet). Some products also come with a skin cream to be applied to the area around the outside of the vagina. Ask your doctor before using this medication for self-treatment if this is your first vaginal infection. This medication only works for vaginal fungal infections. You may have a different type of infection (such as bacterial vaginosis) and may need a different medication. If you have fever, chills, flu-like symptoms, stomach/abdominal pain, or a bad-smelling vaginal discharge, do not use this medication. Contact your doctor right away because these may be signs of a more serious infection.
  • This medication is used to treat and prevent diaper rash and other minor skin irritations (e.g., burns, cuts, scrapes). It works by forming a barrier on the skin to protect it from irritants/moisture.

NDC Code Structure

  • 0378 - Mylan Pharmaceuticals Inc.

NDC 0378-9730-50

Package Description: 1 TUBE in 1 CARTON > 50 g in 1 TUBE

NDC Product Information

Vusion with NDC 0378-9730 is a a human prescription drug product labeled by Mylan Pharmaceuticals Inc.. The generic name of Vusion is miconazole nitrate, zinc oxide, white petrolatum. The product's dosage form is ointment and is administered via topical form.

Labeler Name: Mylan Pharmaceuticals Inc.

Dosage Form: Ointment - A semisolid3 dosage form, usually containing <20% water and volatiles5 and >50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.

Product Type: Human Prescription Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Vusion Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • MICONAZOLE NITRATE 2.5 mg/g
  • ZINC OXIDE 150 mg/g
  • PETROLATUM 813.5 mg/g

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
  • TRIHYDROXYSTEARIN (UNII: 06YD7896S3)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Pharmacological Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • Azole Antifungal - [EPC] (Established Pharmacologic Class)
  • Azoles - [CS]

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Mylan Pharmaceuticals Inc.
Labeler Code: 0378
FDA Application Number: NDA021026 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: NDA - A product marketed under an approved New Drug Application. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 02-06-2020 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

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Vusion Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

1.1 Indication

VUSION Ointment is indicated for the adjunctive treatment of diaper dermatitis only when complicated by documented candidiasis (microscopic evidence of pseudohyphae and/or budding yeast), in immunocompetent pediatric patients 4 weeks and older. A positive fungal culture for Candida albicans is not adequate evidence of candidal infection since colonization with C. albicans can result in a positive culture. The presence of candidal infection should be established by microscopic evaluation prior to initiating treatment.VUSION should be used as part of a treatment regimen that includes measures directed at the underlying diaper dermatitis, including gentle cleansing of the diaper area and frequent diaper changes. VUSION should not be used as a substitute for frequent diaper changes.

1.2 Limitations Of Use

The safety and efficacy of VUSION have not been demonstrated in immunocompromised patients, or in infants less than 4 weeks of age (premature or term).The safety and efficacy of VUSION have not been evaluated in incontinent adult patients. VUSION should not be used to prevent the occurrence of diaper dermatitis, such as in an adult institutional setting, since preventative use may result in the development of drug resistance.

2 Dosage And Administration

VUSION is not for oral, ophthalmic, or intravaginal use. Before applying VUSION, 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 VUSION to the diaper area with each diaper change for 7 days. Do not rub VUSION into the skin as this may cause additional irritation. Thoroughly wash hands after applying VUSION. Continue treatment for the full 7 days, even if there is improvement. Do not use VUSION for longer than 7 days. The safety of VUSION when used for longer than 7 days is not known. If symptoms have not improved by day 7, see your health care provider.

3 Dosage Forms And Strengths

VUSION (miconazole nitrate, zinc oxide and white petrolatum) contains 2.5 mg of miconazole nitrate USP, 150 mg of zinc oxide USP and 813.5 mg of white petrolatum USP per gram.

4 Contraindications

None

5.1 Skin Irritation

If irritation occurs or if the disease worsens, discontinue use of the medication, and contact the health care provider.

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 VUSION 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 VUSION 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 VUSION. 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 relationship to drug exposure.Gastrointestinal Disorders: vomitingGeneral Disorders and Administration Site Conditions: burning sensation, condition aggravated, inflammation, painInjury, Poisoning and Procedural Complications: accidental exposureSkin and Subcutaneous Tissue Disorders: blister, dermatitis contact, diaper dermatitis, dry skin, erythema, pruritus, rash, skin exfoliation

7 Drug 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 VUSION is unknown.

Risk Summary

There are no available data on VUSION Ointment use in pregnant women to inform a drug‑associated risk for adverse developmental outcomes. In animal reproduction studies, prolonged gestation, increased number of resorptions, and decreased numbers of live young were observed after oral administration of miconazole nitrate during organogenesis to pregnant rats and rabbits. No comparisons of animal exposure with human exposure may be calculated due to minimal systemic exposure in humans after topical administration of VUSION [see Clinical Pharmacology (12.3)].In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

There is no available information on the presence of miconazole in human milk, or the effects on the breastfed child, or the effects on milk production following use of VUSION. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for VUSION and any potential adverse effects on the breastfed infant from VUSION or from the underlying maternal condition.

Animal Data

Miconazole nitrate administration has been shown to result in prolonged gestation and decreased numbers of live young in rats and in increased number of resorptions and decreased number of live young in rabbits at oral doses of 100 mg/kg/day and 80 mg/kg/day.

8.4 Pediatric Use

Efficacy was not demonstrated in infants less than 4 weeks of age. Safety and efficacy have not been established in very-low-birth-weight infants (less than 1500 g). VUSION should not be used to prevent diaper dermatitis.The safety of VUSION when used for longer than 7 days is not known. Do not use more than 7 days.

8.5 Geriatric Use

Safety and efficacy in a geriatric population have not been evaluated.

11 Description

VUSION 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 C18H14Cl4N2O•HNO3 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 CnH2n+2. The hydrocarbons consist mainly of branched and unbranched chains. White petrolatum contains butylated hydroxytoluene (BHT) as stabilizer.Each gram of VUSION 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.VUSION is a smooth, uniform, white ointment.

12.1 Mechanism Of Action

The miconazole component of VUSION is an antifungal agent [see Clinical Pharmacology (12.4)]. The mechanism of action of white petrolatum and zinc oxide for the adjunctive treatment of diaper dermatitis is unknown.

12.2 Pharmacodynamics

The human pharmacodynamics of Vusion is unknown [see Clinical Pharmacology (12.4) for fungal pharmacodynamics].

12.3 Pharmacokinetics

The topical absorption of miconazole from VUSION was studied in immunocompetent male and female infants and children (n=17) with diaper dermatitis complicated by documented candidiasis (microscopic evidence of pseudohyphae and/or budding yeast) ranging in age from 1 month to 21 months. After multiple daily applications to the affected area at every diaper change (approximately 5-12 times per day) for 7 days, the plasma concentrations of miconazole were below the lower limit of quantitation (LOQ) of 0.5 ng/mL in 15 out of 17 (88%) subjects. In the other 2 remaining subjects, the plasma concentrations of miconazole were 0.57 and 0.58 ng/mL, respectively at a single timepoint (4 hours after the last application) on Day 7.

12.4 Microbiology

The miconazole nitrate component in this product has been shown to have in vitro activity against Candida albicans, an organism that is associated with diaper dermatitis. The activity of miconazole nitrate against C. albicans is based on the inhibition of the ergosterol biosynthesis in the cell membrane. The accumulation of ergosterol precursors and toxic peroxides results in cytolysis of the cell. In vitro minimal inhibitory concentration (MIC) test results for C. albicans isolates obtained from treatment failures in Clinical Study 1 [see Clinical Studies (14)] does not appear to indicate that resistance to miconazole nitrate was the reason for treatment failure. The clinical significance of the in vitro activity of miconazole nitrate against C. albicans in the setting of diaper dermatitis is unclear.

13.1 Carcinogenesis, Mutagenesis, Impairment Of Fertility

The carcinogenic potential of VUSION in animals has not been evaluated.Miconazole nitrate was negative in a bacterial reverse mutation test, a chromosome aberration test in mice, and micronucleus assays in mice and rats.Miconazole nitrate had no adverse effect on fertility in a study in rats at oral doses of up to 320 mg/kg/day.

14 Clinical Studies

Study 1 was a double-blind, multicenter study in which VUSION was compared to the zinc oxide and white petrolatum combination treatment and included 236 infants and toddlers with diaper dermatitis, complicated by candidiasis as documented by KOH tests that demonstrated pseudohyphae and/or budding yeasts. Study medication was applied at every diaper change for 7 days.The primary endpoint was “Overall Cure” and required that subjects be both clinically cured (total resolution of all signs and symptoms of infection) and microbiologically cured (eradication of candidiasis). Primary efficacy was assessed 1 week following the end of treatment, at Day 14.Study results are shown in the following table.Overall Cure at Day 14 VUSIONn=112Zinc Oxide/White Petrolatumn=124 26 (23%) 12 (10%)Two additional studies provided supportive evidence of the clinical efficacy of VUSION in infants and toddlers with diaper dermatitis, some of whom cultured positive for C. albicans. However, candidal infection was not documented in the culture-positive subjects, as microscopic testing (e.g. KOH) was not done. Therefore, the positive culture results may have reflected colonization rather than infection.

16.1 How Supplied

VUSION (miconazole nitrate, zinc oxide and white petrolatum) contains 2.5 mg of miconazole nitrate USP, 150 mg of zinc oxide USP and 813.5 mg of white petrolatum USP per gram. The smooth, uniform, white ointment supplied in an aluminum tube is available as follows:NDC 0378-9730-50carton containing one 50 gram tube

16.2 Storage Conditions

Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Keep out of reach of children.

17 Patient Counseling Information

  • See FDA-Approved Patient LabelingPatients using VUSION should be informed about the following information: •VUSION should be used only as directed by the health care provider. •VUSION should not be used as a substitute for frequent diaper changes. •VUSION should not be used to prevent diaper dermatitis. •VUSION is for external use only. It is not for oral, ophthalmic, or intravaginal use. •Gently cleanse the diaper area with lukewarm water or a very mild soap and pat the area dry with a soft towel before applying VUSION. •Gently apply VUSION to the diaper area with the fingertips after each diaper change. Do not rub VUSION into the skin as this may cause additional irritation. •Thoroughly wash hands after applying VUSION. •Treatment should be continued for 7 days, even if there is improvement. Do not use VUSION for longer than 7 days. If symptoms have not improved by day 7, see your health care provider. •VUSION should not be used on children for whom it is not prescribed.

Patient Information

  • VUSION® (Vu-sion) (miconazole nitrate, zinc oxide, and white petrolatum) OintmentImportant Information:VUSION is for use on the skin only. Do not use VUSION in the eyes, mouth, or vagina. What is VUSION?VUSION Ointment is a prescription medicine used on the skin (topical) to treat children 4 weeks of age and older with a normal immune system who have diaper rash (dermatitis) and who also have a yeast infection (candidiasis). •Your child’s healthcare provider should do a test to check to make sure that your child also has a yeast infection before starting treatment with VUSION. •VUSION should be used along with gentle cleaning of the diaper area and changing your child’s diaper often. See, “How should I use VUSION?” for detailed instructions on how to use VUSION the right way. •VUSION should not be used to prevent diaper rash from developing (preventative treatment). Using VUSION as preventative treatment may cause VUSION to no longer work (resistance). It is not known if VUSION is safe and effective for use in incontinent adults.It is not known if VUSION is safe and effective for use in children less than 4 weeks of age or very low birth weight (less than 1500 grams). Before using VUSION, tell your child’s healthcare provider about all their medical conditions..How should I use VUSION? •Use VUSION exactly as your child’s healthcare provider tells you to use it. •Gently clean the skin on your child’s diaper area with warm (not hot) water and pat the area dry with a soft towel. •Using your fingertips, apply a thin layer of VUSION to the affected area at each diaper change for 7 days. Do not rub VUSION into your child’s skin. Rubbing the skin can cause more irritation. •Wash your hands after applying VUSION. •VUSION should be used for the full 7 days of treatment. Do not stop treatment before the full 7 days, even if the symptoms improve. •VUSION should not be used for longer than 7 days. Call your child’s healthcare provider if the diaper rash gets worse or does not go away with 7 days of treatment with VUSION. •Call your child’s healthcare provider or poison control center right away if VUSION is swallowed or gets in the eyes.What should I avoid while using VUSION? •Avoid using scented soaps, shampoos or lotions in the diaper area during treatment with VUSION.What are the possible side effects of VUSION?VUSION may cause serious side effects, including: •Skin irritation. Stop using VUSION and call your child’s healthcare provider if your child’s diaper rash gets worse or if your child develops skin irritation at the application site during treatment with VUSION. These are not all the possible side effects of VUSION. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. How should I store VUSION? •Store VUSION at room temperature between 68° to 77°F (20° to 25°C). •Keep VUSION and all medicines out of the reach of children. General information about the safe and effective use of VUSION.Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use VUSION for a condition for which it was not prescribed. Do not give VUSION to other people, even if they have the same symptoms your child has. It may harm them. You can ask your child’s healthcare provider or pharmacist for information about VUSION that is written for healthcare professionals.What are the ingredients in VUSION?Active Ingredients:  miconazole nitrate, zinc oxide, and white petrolatum Inactive Ingredients:  trihydroxystearin, butylated hydroxytoluene (BHT), and Chemoderm 1001/B fragrance Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.     This Patient Information leaflet has been approved by the U.S. Food and Drug Administration. Revised: 8/2018VUSION is a registered trademark of Stiefel Laboratories, Inc., a GSK Company, exclusively licensed to the Mylan Companies.©2018 Mylan Pharmaceuticals Inc. All rights reserved.Manufactured for:Mylan Pharmaceuticals Inc.Morgantown, WV 26505 U.S.A.Manufactured by:Confab Laboratories, Inc.Saint-Hubert, QC, CanadaRevised: 8/2018DPT:MZPOIN:R1

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