OTC Medication Information: Tioconazole 1 Day

TIOCONAZOLE 1 DAY- tioconazole ointment
Insight Pharmaceuticals LLC

Drug Facts

Active ingredient (in each applicator)

Tioconazole 300 mg (6.5%)

Purpose

Vaginal antifungal

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, 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?

call toll-free 877-666-4782 or 215-273-8755 (collect)

Distributed by: INSIGHT Pharmaceuticals, LLC.
Langhorne, PA 19047-1749

PRINCIPAL DISPLAY PANEL — 4.6g Applicator Carton

1 DAY TREATMENT • PREFILLED APPLICATOR

1-DAY
Tioconazole Ointment 6.5%
VAGINAL ANTIFUNGAL

CURES MOST VAGINAL YEAST INFECTIONS

CLINICALLY PROVEN
1 DAY TREATMENT

Net Wt. 4.6g (0.16oz) filled applicator

PRINCIPAL DISPLAY PANEL -- 4.6g Applicator Carton
(click image for full-size original)
TIOCONAZOLE 1 DAY
tioconazole ointment
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:63736-410
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Tioconazole (Tioconazole) Tioconazole 300 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
butylated hydroxyanisole
magnesium aluminum silicate
petrolatum
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63736-410-01 1 POUCH in 1 CARTON contains a POUCH
1 1 APPLICATOR in 1 POUCH This package is contained within the CARTON (63736-410-01) and contains a APPLICATOR
1 4.6 g in 1 APPLICATOR This package is contained within a POUCH and a CARTON (63736-410-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075915 11/21/2001
Labeler — Insight Pharmaceuticals LLC (176792315)
Establishment
Name Address ID/FEI Operations
Perrigo 006013346 MANUFACTURE (63736-410)

Revised: 07/2012 Insight Pharmaceuticals LLC

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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