1-day Tioconazole Ointment 6.5%

1-day Tioconazole Ointment 6.5%
SPL v1
SPL
SPL Set ID 41258b67-6ce7-48f1-9787-6824902cb203
Route
TOPICAL
Published
Effective Date 2012-07-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Tioconazole (300 mg)
Inactive Ingredients
Butylated Hydroxyanisole Magnesium Aluminum Silicate Petrolatum

Identifiers & Packaging

Marketing Status
ANDA Active Since 2001-11-21

Description

Drug Facts

Purpose

Vaginal antifungal


Medication Information

Purpose

Vaginal antifungal

Description

Drug Facts

Use
  • treats vaginal yeast infections
Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50570-1

For vaginal use only

Do not use if you have never had a vaginal yeast infection diagnosed by a doctor

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

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
Questions?

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

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

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
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
Active Ingredient (in Each Applicator)

Tioconazole 300 mg (6.5%)

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


Structured Label Content

Use
  • treats vaginal yeast infections
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50570-1 (50570-1)

For vaginal use only

Do not use if you have never had a vaginal yeast infection diagnosed by a doctor

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Purpose

Vaginal antifungal

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
Questions?

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

Other Information (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 (Inactive ingredients)

butylated hydroxyanisole, magnesium aluminum silicate, white petrolatum

When Using This Product (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 (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
Ask A Doctor Before Use If You Have (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
Active Ingredient (in Each Applicator) (Active ingredient (in each applicator))

Tioconazole 300 mg (6.5%)

Principal Display Panel 4.6g Applicator Carton (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


Advanced Ingredient Data


Raw Label Data

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