Wednesday, October 12, 2016

Topcare Tioconazole 1





Dosage Form: ointment
Topco Tioconazole 1 Drug Facts

Active ingredient (in each applicator)


Tioconazole 300 mg (6.5%)



Purpose


Vaginal antifungal



Uses


  • treats vaginal yeast infections


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 human immunodeficiency virus (HIV) that causes AIDS


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 disease (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 after 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 brochure and instructions on foil packet for complete directions and information

  • adults and children 12 years and over:

  • open the foil packet just before use and remove purple cap

  • insert entire contents of applicator into the vagina at bedtime. Throw applicator away after use.

  • children under 12 years of age: ask a doctor


Other information


  • this product is a 1-dose treatment, most women do not experience complete relief of their symptoms in just one day. Most women experience some relief within one day and complete relief of symptoms within 7 days.

  • if you have questions about vaginal yeast infections, consult your doctor

  • store at 20° - 25°C (68° - 77°F)

  • see end flap of carton for lot number and expiration date


Inactive ingredients


butylated hydroxyanisole, magnesium aluminum silicate, white petrolatum



Questions or comments?


1-888-423-0139



Principal Display Panel


1-Dose Vaginal Treatment


Tioconazole 1


Tioconazole Ointment 6.5%


Vaginal Antifungal


Cures Most Vaginal Yeast Infections


1 Ready-to-Use Convenient Prefilled Applicator


Compare to 1-Day™ active ingredient


Tioconazole 1 Carton










Topcare Tioconazole 1 
tioconazole  ointment










Product Information
Product TypeHUMAN OTC DRUGNDC Product Code (Source)36800-426
Route of AdministrationVAGINALDEA Schedule    








Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TIOCONAZOLE (TIOCONAZOLE)TIOCONAZOLE6.5 g  in 100 g





Inactive Ingredients
Ingredient NameStrength
No Inactive Ingredients Found


















Product Characteristics
ColorBROWN (light to dark tan)Score    
ShapeSize
FlavorImprint Code
Contains      














Packaging
#NDCPackage DescriptionMultilevel Packaging
136800-426-541 APPLICATOR In 1 CARTONcontains a APPLICATOR
14.6 g In 1 APPLICATORThis package is contained within the CARTON (36800-426-54)










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07591503/03/2008


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




More Topcare Tioconazole 1 resources


  • Topcare Tioconazole 1 Side Effects (in more detail)
  • Topcare Tioconazole 1 Use in Pregnancy & Breastfeeding
  • Topcare Tioconazole 1 Support Group
  • 7 Reviews for Topcare Tioconazole - Add your own review/rating


Compare Topcare Tioconazole 1 with other medications


  • Vaginal Yeast Infection

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