FDA-Approved Patient Labeling
VUSION® (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 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, ask your health care provider, or pharmacist.
What is VUSION?
VUSION 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 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, 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 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 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?
VUSION is not for treatment of all cases of diaper rash. VUSION 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 because most cases of diaper rash do not also have a yeast infection.
Do not use VUSION on any other children or other family member.
Do not use VUSION 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.
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 on my child?
VUSION is applied to the skin on your child’s diaper area at each diaper change for 7 days.
Apply VUSION 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. VUSION should not be used for more than 7 days.
To apply VUSION:
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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.
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Use your fingertips and gently apply a thin layer of VUSION to your child’s diaper area at each diaper change. Do not rub VUSION into your child’s skin. Rubbing the skin can cause more irritation.
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Wash your hands after applying VUSION on your child.
VUSION is for skin use only.
Call your child’s health care provider or poison control center right away if any VUSION is swallowed. Call your child’s health care provider if VUSION gets in the eye.
Keep out of reach of children.
What other steps will help diaper rash go away?
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Check your child’s diaper often. Change the diaper at the first sign of wetness.
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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.
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Keep the diaper area open to air when possible.
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Even if you use VUSION, 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?
VUSION 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?
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Keep VUSION out of the reach of children to avoid the risk of accidental ingestion.
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Store VUSION at room temperature between 68°F to 77°F (20°C to 25°C).
General information about VUSION
Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets.
Do not use VUSION for a condition for which it was not prescribed. Do not give VUSION 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. 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 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?
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
VSN:2PIL
Manufactured for:
Stiefel Laboratories, Inc.
Coral Gables, FL 33134 USA
Manufactured by:
DSM Pharmaceuticals, Inc.
Greenville, NC 27834
VUSION, STIEFEL, and STIEFEL & Design are registered trademarks of Stiefel Laboratories, Inc.
1Chemoderm is a registered trademark of Firmenich Inc.
©2010 Stiefel Laboratories, Inc.
Revised March 2010
SAP#
P/N #
Relabeling of "Additional" barcode label by;
Physicians Total Care, Inc.
Tulsa, OK 74146
