TIOCONAZOLE description, usages, side effects, indications, overdosage, supplying and lots more!

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TIOCONAZOLE

DPT Laboratories, Ltd.
DPT Laboratories, Ltd.


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient

Active ingredient
(i n each applicator)


Purpose

Use

  • 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,Keep out of reach of children.

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: 1.Open the foil packet just before use and remove purple cap. 2.Insert entire contents of applicator into the vagina at bedtime. Throw applicator away after use.
  • children under 12 years of age: ask a doctor

TIOCONAZOLE 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

Uses




TIOCONAZOLE OINTMENT 6.5%


DIRECTIONS FOR USE

  • Tear open foil packet just before using. It is best to use at bedtime.
  • Remove applicator and plunger from packet. Applicator is prefilled with vaginal ointment.
  • While firmly holding the purple-capped end of the applicator, push the tip of the plunger into the base of applicator.
TIOCONAZOLE
REMOVE PURPLE CAP
TIOCONAZOLE

Insert the applicator

  • Lie on your back with your knees bent. Gently insert applicator into the vagina as far as it will go comfortably.
  • Push the plunger into the applicator until it will go no farther. Withdraw the applicator and plunger and dispose of it in the wastebasket. Do not flush.
  • DO NOT USE TAMPONS while using this medicine. Use sanitary napkins instead.
TIOCONAZOLE







TIOCONAZOLE

TIOCONAZOLE OINTMENT

Product Information

Product Type Human otc drug label Item Code (Source) NDC:63094-0426
Route of Administration VAGINAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
TIOCONAZOLE TIOCONAZOLE 65 mg

Inactive Ingredients

Ingredient Name Strength
BUTYLATED HYDROXYANISOLE
magnesium aluminum silicate
petrolatum

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:63094-0426-1 5 in 1 APPLICATOR

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075915 2007-08-22


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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