Vusion (miconazole nitrate/zinc oxide/white petrolatum)

Vusion (miconazole nitrate, 15% zinc oxide, and 81.35% white petrolatum) may cause irritation. You should call your child's health care provider if irritation appears or if the diaper rash gets worse.

Side effects may be reported to Stiefel Laboratories, Inc. at 1-866-440-5508 or the FDA at 1-800-FDA-1088.

• Vusion (miconazole nitrate, 15% zinc oxide, and 81.35% white petrolatum) is not for oral, ophthalmic, or intravaginal use.
• Before applying Vusion (miconazole nitrate, 15% zinc oxide, and 81.35% white petrolatum) , 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.
• Apply Vusion (miconazole nitrate, 15% zinc oxide, and 81.35% white petrolatum) to the affected area at each diaper change for 7 days.
• Continue treatment for the full 7 days, even if there is improvement.
• The safety of Vusion (miconazole nitrate, 15% zinc oxide, and 81.35% white petrolatum) when used for longer than 7 days is not known. Do not use Vusion (miconazole nitrate, 15% zinc oxide, and 81.35% white petrolatum) for longer than 7 days. If symptoms have not improved by day 7, see your health care provider.
• Gently apply a thin layer of Vusion (miconazole nitrate, 15% zinc oxide, and 81.35% white petrolatum) to the diaper area with the fingertips.
• Do not rub Vusion (miconazole nitrate, 15% zinc oxide, and 81.35% white petrolatum) into the skin as this may cause additional irritation.
• Thoroughly wash hands after applying Vusion (miconazole nitrate, 15% zinc oxide, and 81.35% white petrolatum) .

• 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 (miconazole nitrate, 15% zinc oxide, and 81.35% white petrolatum) is unknown.

• There are no adequate and well-controlled studies of Vusion (miconazole nitrate, 15% zinc oxide, and 81.35% white petrolatum) in pregnant women. Therefore, Vusion (miconazole nitrate, 15% zinc oxide, and 81.35% white petrolatum) should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
• Safety and efficacy of Vusion (miconazole nitrate, 15% zinc oxide, and 81.35% white petrolatum) have not been established in nursing mothers.
• It is not known if the active components of Vusion (miconazole nitrate, 15% zinc oxide, and 81.35% white petrolatum) may be present in milk.