Drug Information for VUSIONTM (0.25% miconazole nitrate, 15% zinc oxide, and 81.35% white petrolatum) OintmentRx only. FOR TOPICAL USE ONLY. NOT FOR OPTHALMIC, ORAL, OR INTRAVAGINAL USE. (Barrier Therapeutics, Inc.): ADVERSE REACTIONS

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  • A total of 835 infants and young children were evaluated in the clinical development program. Of 418 subjects in the VUSION 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 VUSION were approximately the same in type and frequency as for subjects who were treated with zinc oxide/white petrolatum ointment.

    The potential for dermal toxicity of VUSION Ointment formulation was investigated in healthy adult volunteers in four topical safety studies. These studies were conducted to assess the potential for contact phototoxicity, photoallergy, sensitization, and cumulative irritation potential. Phototesting was conducted with UV-A only. Results indicated that VUSION Ointment did not induce a contact dermal phototoxic response, contact dermal photoallergic response, or contact dermal sensitization in adult subjects. In addition, VUSION Ointment did not show any evidence of cumulative irritation potential in adult subjects.

  • Drug Information Provided by National Library of Medicine (NLM).
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