Monday, 3 September 2012

Monistat 7 Combination Pack



miconazole nitrate

Dosage Form: cream
Monistat 7 Combination Pack Triple Action

Drug Facts









Active ingredientsPurpose
Miconazole nitrate 2% (100 mg in each applicatorful)Vaginal antifungal
Miconazole nitrate 2% (external cream)Vaginal antifungal

Uses


  • treats vaginal yeast infections

  • relieves external itching and irritation due to a vaginal yeast infection


Warnings


For vaginal use only



Do not use if you have never had a vaginal yeast infection diagnosed by a doctor



Ask a doctor before use if you have


  • vaginal itching and discomfort for the first time

  • lower abdominal, back or shoulder pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge. You may have a more serious condition.

  • vaginal yeast infections often (such as once a month or 3 in 6 months). You could be pregnant or have a serious underlying medical cause for your symptoms, including diabetes or a weakened immune system.

  • been exposed to the human immunodeficiency virus (HIV) that causes AIDS


Ask a doctor or pharmacist before use if you are taking the prescription blood thinning medicine warfarin, because bleeding or bruising may occur



When using this product


  • do not use tampons, douches, spermicides or other vaginal products. Condoms and diaphragms may be damaged and fail to prevent pregnancy or sexually transmitted diseases (STDs).

  • do not have vaginal intercourse

  • mild increase in vaginal burning, itching or irritation may occur

  • if you do not get complete relief ask a doctor before using another product


Stop use and ask a doctor if


  • symptoms do not get better in 3 days

  • symptoms last more than 7 days

  • you get a rash or hives, abdominal pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge


If pregnant or breast-feeding, ask a health professional before use.



Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.



Directions


  • before using this product, read the enclosed consumer information leaflet for complete directions and information

  • adults and children 12 years of age and over:

  • applicators: insert 1 applicatorful into the vagina at bedtime for 7 nights in a row. Throw away applicator after use.

  • external cream: squeeze a small amount of cream onto your fingertip. Apply the cream onto the itchy, irritated skin outside the vagina (vulva). Use 2 times daily for up to 7 days, as needed.

  • children under 12 years of age: ask a doctor


Other information



  • do not use if seal over tube opening has been punctured or embossed design



  • do not purchase if carton is open

  • store at 20°-25°C (68°-77°F)


Inactive ingredients


  • benzoic acid, cetyl alcohol, isopropyl myristate, polysorbate 60, potassium hydroxide, propylene glycol, purified water, stearyl alcohol


Questions?


If you have any questions or comments, please call 1-877-666-4782



PRINCIPAL DISPLAY PANEL - Kit Carton


NDC-30014-003-07


MONISTAT®7

COMBINATION PACK

Miconazole Nitrate Cream (2%) and Miconazole Nitrate Cream (2%)


(Miconazole Nitrate 100 mg per applicator)


ORTHO

CLINICALLY PROVEN

Multi-Symptom Relief


VAGINAL ANTIFUNGAL


CURES MOST VAGINAL YEAST INFECTIONS AND

RELIEVES ASSOCIATED EXTERNAL ITCHING AND IRRITATION


7-Day Vaginal Cream with Disposable Applicators

PLUS External Cream


Net Wt. 1.59 oz. (45g)

+ 0.32 oz. (9g) Tube
























Monistat 7 Combination Pack  TRIPLE ACTION
miconazole nitrate  kit






Product Information
Product TypeHUMAN OTC DRUGNDC Product Code (Source)30014-003










Packaging
#NDCPackage DescriptionMultilevel Packaging
130014-003-071 KIT In 1 PACKAGE, COMBINATIONNone











QUANTITY OF PARTS
Part #Package QuantityTotal Product Quantity
Part 11 TUBE, WITH APPLICATOR  0.1 g
Part 21 TUBE  0.009 g



Part 1 of 2
MICONAZOLE NITRATE 
miconazole nitrate  cream










Product Information
   
Route of AdministrationVAGINALDEA Schedule    








Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Miconazole Nitrate (Miconazole)Miconazole Nitrate20 mg  in 1 g





Inactive Ingredients
Ingredient NameStrength
No Inactive Ingredients Found


















Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains      










Packaging
#NDCPackage DescriptionMultilevel Packaging
10.1 g In 1 TUBE, WITH APPLICATORNone










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01745004/10/2010




Part 2 of 2
MICONASOLE NITRATE 
miconazole nitrate  cream










Product Information
   
Route of AdministrationVAGINALDEA Schedule    








Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Miconazole Nitrate (Miconazole)Miconazole Nitrate20 mg  in 1 g





Inactive Ingredients
Ingredient NameStrength
No Inactive Ingredients Found


















Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains      










Packaging
#NDCPackage DescriptionMultilevel Packaging
10.009 g In 1 TUBENone










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01745004/10/2010











Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01745004/10/2010


Labeler - McNeil, PPC, Inc. (801375143)
Revised: 04/2010McNeil, PPC, Inc.




More Monistat 7 Combination Pack resources


  • Monistat 7 Combination Pack Side Effects (in more detail)
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  • Monistat 7 Combination Pack Support Group
  • 0 Reviews for Monistat 7 Combination Pack - Add your own review/rating


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