Thursday, September 29, 2016

Miconazole 1 Drug Facts





Dosage Form: vaginal insert, cream
Walgreen Co. Miconazole 1 Drug Facts

Active ingredient


Miconazole nitrate 1200 mg (in vaginal insert)


Miconazole nitrate 2% (external cream)



Purpose


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. (1-800-222-1222)



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:

  • vaginal insert: with the applicator place the vaginal insert into the vagina. Throw applicator away after use.

  • external cream: squeeze a small amount of cream onto your fingertip. Apply the cream onto the itchy, irritated skin outside the vagina. 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 printed sealed vaginal insert blister is torn, open or incompletely sealed

  • do not use if seal over tube opening has been punctured or cannot be seen

  • do not purchase if carton is open

  • store at 20°-25°C (68°-77°F)

  • this is a 1-dose treatment. Most women do not get complete relief of their symptoms in just 1 day. Most women get some improvement in 1 day and complete relief by 7 days.

  • see end panel for lot number and expiration date


Inactive ingredients


  • vaginal insert: fractionated coconut oil, gelatin, glycerin, lecithin, light mineral oil, purified water, titanium dioxide, white petrolatum

  • external cream: benzoic acid, butylated hydroxyanisole, glyceryl stearate, mineral oil, peglicol 5 oleate, pegoxol 7 stearate, purified water


Questions or comments?


1-800-719-9260



Principal Display Panel


1-Day Treatment


Daytime-or-Nighttime


Stays in Place


1 Softgel Insert with 1 Flexible Applicator


Plus External Cream for Itch Relief


Compare to Monistat® 1 active ingredients


Miconazole 1


Miconazole Nitrate Vaginal Insert (1200 mg) and Miconazole Nitrate Cream (2%)


Vaginal Antifungal


Combination Pack


Cures Most Vaginal Yeast Infections And Relieves Associated External Itching and Irritation


1 Softgel insert with 1 Flexible Applicator Plus External Itch Relief Cream


Miconazole 1 Carton
























MICONAZOLE 1 
miconazole nitrate  kit






Product Information
Product TypeHUMAN OTC DRUGNDC Product Code (Source)0363-0199










Packaging
#NDCPackage DescriptionMultilevel Packaging
10363-0199-001 KIT In 1 CARTONNone











QUANTITY OF PARTS
Part #Package QuantityTotal Product Quantity
Part 11 BLISTER PACK  
Part 21 TUBE  9 g



Part 1 of 2
MICONAZOLE NITRATE 
miconazole nitrate  insert










Product Information
   
Route of AdministrationVAGINALDEA Schedule    








Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MICONAZOLE NITRATE (MICONAZOLE)MICONAZOLE NITRATE1200 mg





Inactive Ingredients
Ingredient NameStrength
No Inactive Ingredients Found


















Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains      










Packaging
#NDCPackage DescriptionMultilevel Packaging
11 INSERT In 1 BLISTER PACKNone










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA079114




Part 2 of 2
MICONAZOLE NITRATE 
miconazole nitrate  cream










Product Information
   
Route of AdministrationTOPICALDEA Schedule    








Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MICONAZOLE NITRATE (MICONAZOLE)MICONAZOLE NITRATE2 g  in 100 g





Inactive Ingredients
Ingredient NameStrength
No Inactive Ingredients Found


















Product Characteristics
ColorWHITE (to off white, viscous)Score    
ShapeSize
FlavorImprint Code
Contains      










Packaging
#NDCPackage DescriptionMultilevel Packaging
19 g In 1 TUBENone










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA079114











Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07911406/10/2010


Labeler - Walgreen Company (008965063)
Revised: 06/2010Walgreen Company




More Miconazole 1 Drug Facts resources


  • Miconazole 1 Drug Facts Use in Pregnancy & Breastfeeding
  • Miconazole 1 Drug Facts Drug Interactions
  • Miconazole 1 Drug Facts Support Group
  • 8 Reviews for Miconazole Drug Facts - Add your own review/rating


Compare Miconazole 1 Drug Facts with other medications


  • Cutaneous Candidiasis
  • Oral Thrush
  • Tinea Corporis
  • Tinea Cruris
  • Tinea Pedis
  • Tinea Versicolor
  • Vaginal Yeast Infection

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