VUSION

5 WARNINGS AND PRECAUTIONS • 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.

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 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 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