1 INDICATIONS AND USAGE • VUSION Ointment is indicated for adjunctive treatment of diaper dermatitis when complicated by documented candidiasis (microscopic evidence of pseudohyphae and /or budding yeast) in immunocompetent pediatric patients 4 weeks and older.

( 1.1 ) • VUSION Ointment should not be used as a substitute for frequent diaper changes.

( 1.1 ) • VUSION Ointment should not be used to prevent the occurrence of diaper dermatitis, since preventative use may result in the development of drug resistance.

( 1.2 ) 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.

6 ADVERSE REACTIONS 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 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: vomiting General Disorders and Administration Site Conditions: burning sensation, condition aggravated, inflammation, pain Injury, Poisoning and Procedural Complications: accidental exposure Skin and Subcutaneous Tissue Disorders: blister, dermatitis contact, diaper dermatitis, dry skin, erythema, pruritus, rash, skin exfoliation