Enter section text here

VUSION is not for oral, ophthalmic, or intravaginal use.

Before applying VUSION, 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 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 when used for longer than 7 days is not known. Do not use VUSION 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 to the diaper area with the fingertips. Do not rub VUSION into the skin as this may cause additional irritation. Thoroughly wash hands after applying VUSION.

White ointment containing 0.25% miconazole nitrate, 15% zinc oxide, and 81.35% white petrolatum.

None

If irritation occurs or if the disease worsens, discontinue use of the medication, and contact the health care provider.

The safety and efficacy of VUSION have not been evaluated in incontinent adult patients. VUSION should not be used to prevent the occurrence of diaper dermatitis, such as in an adult institutional setting, since preventative use may result in the development of drug resistance.

Enter section text here

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 is unknown.

Enter section text here

VUSION contains the synthetic antifungal agent, miconazole nitrate (0.25%) USP, zinc oxide (15%) USP, and white petrolatum (81.35%) USP.

The chemical name of miconazole nitrate is 1-[2, 4-dichloro-ß-{(2,4-dichlorobenzyl)oxy} phenethyl] imidazole mononitrate with empirical formula C18H14Cl4N2O•HNO3 and molecular weight of 479.15. The structural formula of miconazole nitrate is as follows:

The zinc oxide has an empirical formula of ZnO and a molecular weight of 81.39.

The white petrolatum, which is obtained from petroleum and is wholly or nearly decolorized, is a purified mixture of semisolid saturated hydrocarbons having the general chemical formula CnH2n+2. The hydrocarbons consist mainly of branched and unbranched chains. White petrolatum contains butylated hydroxytoluene (BHT) as stabilizer.

Each gram of VUSION contains 2.5 mg of miconazole nitrate USP, 150 mg of zinc oxide USP, and 813.5 mg of white petrolatum USP containing butylated hydroxytoluene, trihydroxystearin, and  Chemoderm® 1001/B fragrance.1

VUSION is a smooth, uniform, white ointment.

Enter section text here

Enter section text here

Study 1 was a double-blind, multicenter study in which VUSION was compared to the zinc oxide and white petrolatum combination treatment and included 236 infants and toddlers with diaper dermatitis, complicated by candidiasis as documented by KOH tests that demonstrated psuedohyphae and/or budding yeasts. Study medication was applied at every diaper change for 7 days.

The primary endpoint was “Overall Cure” and required that subjects be both clinically cured (total resolution of all signs and symptoms of infection) and microbiologically cured (eradication of candidiasis). Primary efficacy was assessed 1 week following the end of treatment, at Day 14.

Study results are shown in the following table.

Two additional studies provided supportive evidence of the clinical efficacy of VUSION in infants and toddlers with diaper dermatitis, some of whom cultured positive for C. albicans. However, candidal infection was not documented in the culture-positive subjects, as microscopic testing (e.g. KOH) was not done. Therefore, the positive culture results may have reflected colonization rather than infection.

Enter section text here

See FDA-Approved Patient Labeling

Patients using VUSION should be informed about the following information:

• VUSION is to be used only for diaper dermatitis that is complicated by documented candidiasis (i.e. documented by microscopic testing).
• VUSION should not be used as a substitute for frequent diaper changes.
• VUSION should not be used to prevent diaper dermatitis.
• VUSION should not be used long term.
• VUSION should be used only as directed by the health care provider.
• VUSION is for external use only. It is not for oral, ophthalmic, or intravaginal use.
• Gently cleanse the diaper area with lukewarm water or a very mild soap and pat the area dry with a soft towel before applying VUSION.
• Gently apply VUSION to the diaper area with the fingertips after each diaper change. Do not rub VUSION into the skin as this may cause additional irritation.
• Thoroughly wash hands after applying VUSION.
• Treatment should be continued for 7 days, even if there is improvement. Do not use VUSION for longer than 7 days. If symptoms have not improved by day 7, see your health care provider.
• VUSION should not be used on children for whom it is not prescribed.

VSN:2PI

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:

• 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 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.
• 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?

• 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, 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?

• Keep VUSION out of the reach of children to avoid the risk of accidental ingestion.
• 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

NDC 0145-0002-04

Vusion®

(miconazole nitrate 0.25% USP, zinc oxide 15% USP, white petrolatum 81.35% USP)

Ointment

50 grams

Rx only

For topical use only

Usual Dosage: See package insert.

Caution: Not for oral, ophthalmic, or intravaginal use. Keep out of reach of children. If seal is damaged or punctured, do not use, and return product to place of purchase.

Description: Each gram of VUSION® Ointment contains 2.5 mg miconazole nitrate USP, 150 mg zinc oxide USP, and 813.5 mg white petrolatum USP containing butylated hydroxytoluene, trihydroxystearin, and Chemoderm® 1001/B fragrance.

Store at 15oC (77oF); excursions permitted to 25oC -30oC (59oF -86oF).

See tube crimp for lot number and expiration date.