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VUSION® (miconazole nitrate, 15% zinc oxide, and 81.35% white petrolatum)
(Vu-sion) Ointment
(0.25% miconazole nitrate, 15% zinc oxide and 81.35% white petrolatum)

IMPORTANT: For Skin Use Only. Do not use in the mouth, eyes, or vagina.

Read the Patient Information that comes with VUSION (miconazole nitrate, 15% zinc oxide, and 81.35% white petrolatum) before you use it on your child. This leaflet does not take the place of talking to your health care provider about your child's medical condition or treatment. If you have any questions or if you are not sure about any of the information on VUSION (miconazole nitrate, 15% zinc oxide, and 81.35% white petrolatum) , ask your health care provider, or pharmacist.

What is VUSION (miconazole nitrate, 15% zinc oxide, and 81.35% white petrolatum) ?

VUSION (miconazole nitrate, 15% zinc oxide, and 81.35% white petrolatum) is a prescription skin medicine used to treat diaper rash that also has a yeast infection in children who are at least 4 weeks old and who have a normal immune system. VUSION (miconazole nitrate, 15% zinc oxide, and 81.35% white petrolatum) contains medicines that will help treat the yeast infection and the diaper rash, but you must also change your child's diapers very often so that your child is not wearing a wet or soiled diaper. Even if you use VUSION (miconazole nitrate, 15% zinc oxide, and 81.35% white petrolatum) , diaper rash will not go away if you do not keep your child's diaper area clean and dry. You should use water or a very mild cleanser to clean your child's diaper area. VUSION (miconazole nitrate, 15% zinc oxide, and 81.35% white petrolatum) is not to be used to prevent diaper rash or to be used for more than 7 days.

Your health care provider will need to do a special test to tell if your child's diaper rash also has a yeast infection. Do not use VUSION (miconazole nitrate, 15% zinc oxide, and 81.35% white petrolatum) on your child's diaper rash unless your health care provider tells you that there is also a yeast infection.

Who should not use VUSION (miconazole nitrate, 15% zinc oxide, and 81.35% white petrolatum) ?

VUSION (miconazole nitrate, 15% zinc oxide, and 81.35% white petrolatum) is not for treatment of all cases of diaper rash. VUSION (miconazole nitrate, 15% zinc oxide, and 81.35% white petrolatum) is only for diaper rash that also has a yeast infection. Most cases of diaper rash do not need the yeast medicine that is in VUSION (miconazole nitrate, 15% zinc oxide, and 81.35% white petrolatum) because most cases of diaper rash do not also have a yeast infection.

Do not use VUSION (miconazole nitrate, 15% zinc oxide, and 81.35% white petrolatum) on any other children or other family member.

Do not use VUSION (miconazole nitrate, 15% zinc oxide, and 81.35% white petrolatum) on your child's diaper rash if they are allergic to anything in it. See the end of this leaflet for a list of ingredients in VUSION (miconazole nitrate, 15% zinc oxide, and 81.35% white petrolatum) .

Do not use on infants less than 4 weeks of age.

Do not use in infants or children who do not have a normal immune system.

How should I use VUSION (miconazole nitrate, 15% zinc oxide, and 81.35% white petrolatum) on my child?

VUSION (miconazole nitrate, 15% zinc oxide, and 81.35% white petrolatum) is applied to the skin on your child's diaper area at each diaper change for 7 days.

Apply VUSION (miconazole nitrate, 15% zinc oxide, and 81.35% white petrolatum) for the full 7 days even if the diaper rash starts to go away. Call your child's health care provider if the diaper rash gets worse or does not go away with 7 days of treatment with VUSION (miconazole nitrate, 15% zinc oxide, and 81.35% white petrolatum) . VUSION (miconazole nitrate, 15% zinc oxide, and 81.35% white petrolatum) should not be used for more than 7 days.

To apply VUSION (miconazole nitrate, 15% zinc oxide, and 81.35% white petrolatum) :

• Gently, clean the skin on your child's diaper area with warm (not hot) water. You may also use a very mild soap. Pat the area dry with a soft towel.
• Use your fingertips and gently apply a thin layer of VUSION (miconazole nitrate, 15% zinc oxide, and 81.35% white petrolatum) to your child's diaper area at each diaper change. Do not rub VUSION (miconazole nitrate, 15% zinc oxide, and 81.35% white petrolatum) into your child's skin. Rubbing the skin can cause more irritation.
• Wash your hands after applying VUSION (miconazole nitrate, 15% zinc oxide, and 81.35% white petrolatum) on your child.

VUSION (miconazole nitrate, 15% zinc oxide, and 81.35% white petrolatum) is for skin use only.

Call your child's health care provider or poison control center right away if any VUSION (miconazole nitrate, 15% zinc oxide, and 81.35% white petrolatum) is swallowed. Call your child's health care provider if VUSION (miconazole nitrate, 15% zinc oxide, and 81.35% white petrolatum) gets in the eye. Keep out of reach of children.

What other steps will help diaper rash go away?

• Check your child's diaper often. Change the diaper at the first sign of wetness.
• Clean your child's diaper area after each diaper change. Gently wipe the diaper area from the front to back using warm (not hot) water. You may also use a mild soap. Rinse the diaper area well. Pat dry with a soft towel.
• Keep the diaper area open to air when possible.
• Even if you use VUSION (miconazole nitrate, 15% zinc oxide, and 81.35% white petrolatum) , diaper rash will not go away if you do not keep your child's diaper area clean and dry.

What are the possible side effects of VUSION (miconazole nitrate, 15% zinc oxide, and 81.35% 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.

How should I store VUSION (miconazole nitrate, 15% zinc oxide, and 81.35% white petrolatum) ?

• Keep VUSION (miconazole nitrate, 15% zinc oxide, and 81.35% white petrolatum) out of the reach of children to avoid the risk of accidental ingestion.
• Store VUSION (miconazole nitrate, 15% zinc oxide, and 81.35% white petrolatum) at room temperature between 68°F to 77°F (20°C to 25°C).

General information about VUSION (miconazole nitrate, 15% zinc oxide, and 81.35% white petrolatum)

Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets.

Do not use VUSION (miconazole nitrate, 15% zinc oxide, and 81.35% white petrolatum) for a condition for which it was not prescribed. Do not give VUSION (miconazole nitrate, 15% zinc oxide, and 81.35% white petrolatum) to other children or family members, even if they have the same symptoms your child has. It may harm them.

This leaflet summarizes the most important information about VUSION (miconazole nitrate, 15% zinc oxide, and 81.35% white petrolatum) . If you would like more information, talk to your child's health care provider. You can ask your child's health care provider or pharmacist for information about VUSION (miconazole nitrate, 15% zinc oxide, and 81.35% white petrolatum) that is written for healthcare professionals.

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

What are the ingredients in VUSION (miconazole nitrate, 15% zinc oxide, and 81.35% white petrolatum) ?

Active Ingredients: miconazole nitrate, zinc oxide, and white petrolatum

Inactive Ingredients: trihydroxystearin, butylated hydroxyltoluene (BHT), and Chemoderm® 1001/B fragrance

This Patient Information leaflet has been approved by the U.S. Food and Drug Administration. The Patient Information leaflet was last revised: January 2010.

Last reviewed on RxList: 4/27/2010
This monograph has been modified to include the generic and brand name in many instances.