Topcare Tioconazole 1 description, usages, side effects, indications, overdosage, supplying and lots more!

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Topcare Tioconazole 1

Topco Associates LLC

Topco Tioconazole 1 Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient (in each applicator)

Tioconazole 300 mg (6.5%)

Purpose

Vaginal antifungal

Topcare Tioconazole 1 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

Topcare Tioconazole 1 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

Topcare Tioconazole 1
Tioconazole 1 Carton

Topcare Tioconazole 1

Tioconazole OINTMENT

Product Information

Product Type Human otc drug label Item Code (Source) NDC:36800-426
Route of Administration VAGINAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
TIOCONAZOLE TIOCONAZOLE 6.5 g

Product Characteristics

Color
BROWN (light to dark tan)

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 4.6 in 1 APPLICATOR
2 NDC:36800-426-54 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075915 2008-03-03


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Be sure to consult your doctor before taking any medication!
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