Monistat Tioconazole Ointment

Monistat Tioconazole Ointment
SPL v1
SPL
SPL Set ID 587e42b4-cbdc-4a03-afae-f9e5e6605937
Route
TOPICAL
Published
Effective Date 2019-03-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Tioconazole (6.5 g)
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

Uses
  • treats vaginal yeast infections
Other
  • this product is a 1-dose treatment.  Most women do not get complete relief of their symptoms in just one day. Most women get some improvement in 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
Section 42229-5

Drug Facts

Warnings

For vaginal use only

Principal

MONISTAT®

Tioconazole Ointment 6.5%

VAGINAL ANTIFUNGAL

Net Wt. 0.16 OZ (4.6 g) PREFILLED APPLICATOR

Directions
  • before using this product read the enclosed brochure and instructions on foil packet for complete directions and information

  • adults and children 12 years of age and over:

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

    ○ insert entire content of applicator into the vagina at bedtime. Throw applicator away after use.

  • children under 12 years of age: ask a doctor.
Do Not Use

if you have never had a vaginal yeast infection diagnosed by a doctor.

Questions?

1-877-666-4782

Inactive Ingredients

butylated hydroxyanisole, magnesium aluminum silicate, white petrolatum

Keep Out of Reach Of

If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).

If Pregnant Or Breast

ask a health professional before use

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 diseases (STDs).

  • do not have vaginal intercourse

  • mild increase in vaginal burning, itching or irritation may occur

  • if you do not get complete relief ask a doctor before using another product
Stop Use and Ask A Doctor If:
  • symptoms do not get better in 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 the human immunodeficiency virus (HIV) that causes AIDS
Active Ingredient (in Each Applicator)

Tioconazole 300 mg (6.5%)


Structured Label Content

Uses
  • treats vaginal yeast infections
Other
  • this product is a 1-dose treatment.  Most women do not get complete relief of their symptoms in just one day. Most women get some improvement in 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
Section 42229-5 (42229-5)

Drug Facts

Purpose

Vaginal antifungal

Warnings

For vaginal use only

Principal (PRINCIPAL)

MONISTAT®

Tioconazole Ointment 6.5%

VAGINAL ANTIFUNGAL

Net Wt. 0.16 OZ (4.6 g) PREFILLED APPLICATOR

Directions
  • before using this product read the enclosed brochure and instructions on foil packet for complete directions and information

  • adults and children 12 years of age and over:

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

    ○ insert entire content of applicator into the vagina at bedtime. Throw applicator away after use.

  • children under 12 years of age: ask a doctor.
Do Not Use (Do not use)

if you have never had a vaginal yeast infection diagnosed by a doctor.

Questions?

1-877-666-4782

Inactive Ingredients (Inactive ingredients)

butylated hydroxyanisole, magnesium aluminum silicate, white petrolatum

Keep Out of Reach Of (Keep out of reach of)

If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).

If Pregnant Or Breast (If pregnant or breast-)

ask a health professional before use

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 diseases (STDs).

  • do not have vaginal intercourse

  • mild increase in vaginal burning, itching or irritation may occur

  • if you do not get complete relief ask a doctor before using another product
Stop Use and Ask A Doctor If: (Stop use and ask a doctor if:)
  • symptoms do not get better in 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 the human immunodeficiency virus (HIV) that causes AIDS
Active Ingredient (in Each Applicator) (Active ingredient (in each applicator))

Tioconazole 300 mg (6.5%)


Advanced Ingredient Data


Raw Label Data

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