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Details:
VUSION™
Patient Package Insert
(0.25% miconazole nitrate, 15% zinc oxide and 81.35% whitepetrolatum)
Ointment
For Skin Use Only
Read the PatientInformation that comes with VUSION Ointment before you use
it on your
child. This leaflet doesnot take the place of talking to your health care
provider about your
child’s medical condition ortreatment. If you have any questions or if you are
not sure about
any of the information onVUSION Ointment, ask your health care provider, or
pharmacist.
What is VUSION Ointment?
VUSION Ointment is aprescription skin medicine used to treat diaper rash
that also has a
yeast infection in childrenwho have a normal immune system. VUSION Ointment
contains
medicines that will help treatthe yeast infection and the diaper rash, but you
must also
change your child’s diapers very often so that yourchild is not wearing a wet or
soiled
diaper. Even if you use VUSION
Ointment, diaper rash will not go away if you do not keep yourchild’s diaper
area clean
and dry. You should use water or a very mild cleanser toclean your child’s
diaper area.
VUSION Ointment is notused to prevent diaper rash or to be used for more than 7
days.
Who should not use VUSION Ointment?
VUSION Ointment is notfor treatment of all cases of diaper rash. VUSION
Ointment is only
for diaper rash that alsohas a yeast infection. Most cases of diaper rash do not
need the
yeast medicine that is inVUSION Ointment because most cases of diaper rash do
not also
have a yeast infection.
Your health care provider will need to do a specialtest to tell if your child’s
diaper rash
also has a yeast infection. Do not use VUSION Ointment onyour child’s diaper
rash
unless your health care provider tells you that there isalso a yeast infection.
Do not use VUSION Ointment on any other children.
Do not use VUSION Ointment on your child’sdiaper rash if they are allergic to
anything in it. See the end of this leaflet for a list ofingredients in VUSION
Ointment.
How should I use VUSION Ointment on my child?
VUSION Ointment isapplied to the skin on your child’s diaper area at each
diaper change for
7 days.
Apply VUSION Ointmentfor the full 7 days even if the diaper rash starts to go
away. Call your
child’s health care providerif the diaper rash gets worse or does not go away
with 7 days of
treatment with VUSION Ointment.VUSION Ointment should not be usedfor more than 7
days.
To apply VUSION Ointment:
• Gently, clean the skinon 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 fingertipsand gently apply a thin layer of VUSION Ointment to your
child’s
diaper area at each diaperchange. Do not rub VUSION Ointment into your child’s
skin. Rubbing the skin cancause more irritation.
• Wash your hands afterapplying VUSION Ointment on your child.
VUSION Ointment is for skin use only.
Call your child’shealth care provider or poison control center right away if
any VUSION
Ointment is swallowed.Call your child’s health care provider if VUSION Ointment
gets in the
eye.
What other steps will help diaper rash go away?
• Check your child’sdiaper often. Change the diaper at the first sign of
wetness.
• Clean your child’sdiaper area after each diaper change. Gently wipe the diaper
area
from the front to backusing warm (not hot) water. You may alsouse a mild soap.
Rinse the diaper areawell. Pat dry with a soft towel.
• Keep the diaper areaopen to air when possible.
• Even if you use VUSIONOintment, diaper rash will not goaway if you do not keep
your child’s diaper area clean and dry.
What are the possible side effects of VUSIONOintment?
Ointment may causeirritation, but this is not common. You should call your
child’s health
care provider ifirritation appears or if the diaper rash gets worse.
How should I store VUSION Ointment?
• Store VUSION Ointmentat room temperature between 59° to 86°F (15° to
30°C).
• Keep VUSION Ointment out of the reach of children.
General information about VUSION Ointment
What are the ingredients in VUSION Ointment?
Active Ingredients: miconazole nitrate, zinc oxideand white petrolatum
Inactive Ingredients: trihydroxystearin, butylatedhydroxyltoluene (BHT) and
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