Sunday, July 8, 2012

Topcare Miconazole 7





Dosage Form: vaginal cream
Topco Miconazole 7 Drug Facts

Active ingredient


Miconazole nitrate 2% (100 mg in each applicator)



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 a prescription blood thinning medicine, such as 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


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:

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

  • external cream: use the same tube of cream if you have itching and irritation on the skin outside the vagina. Squeeze a small amount of cream onto your fingertip. Apply to 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

  • do not purchase if carton is open

  • store at 20°-25°C (68°-77°F)


Inactive ingredients


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



Questions or comments?


1-888-423-0139



Principal Display Panel


7-Day Vaginal Treatment


Miconazole 7


Miconazole Nitrate Vaginal Cream 2%


Vaginal Antifungal


(Miconazole Nitrate 100 mg per Applicator)


Cures Most Vaginal Yeast Infections


Relieves Associated External Itching and Irritation


7 Disposable Applicators


Compare to Monistat® 7 active ingredient


Miconazole 7 Carton










Topcare Miconazole 7 
miconazole nitrate  cream










Product Information
Product TypeHUMAN OTC DRUGNDC Product Code (Source)36800-825
Route of AdministrationVAGINALDEA 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 (white to off white, viscous)Score    
ShapeSize
FlavorImprint Code
Contains      














Packaging
#NDCPackage DescriptionMultilevel Packaging
136800-825-291 TUBE In 1 CARTONcontains a TUBE, WITH APPLICATOR
145 g In 1 TUBE, WITH APPLICATORThis package is contained within the CARTON (36800-825-29)










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07476002/29/2000


Labeler - Topco Associates LLC (006935977)
Revised: 11/2009Topco Associates LLC




More Topcare Miconazole 7 resources


  • Topcare Miconazole 7 Use in Pregnancy & Breastfeeding
  • Topcare Miconazole 7 Drug Interactions
  • Topcare Miconazole 7 Support Group
  • 8 Reviews for Topcare Miconazole 7 - Add your own review/rating


Compare Topcare Miconazole 7 with other medications


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


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