DG HEALTH TIOCONAZOLE 1- tioconazole ointment

United States - English - NLM (National Library of Medicine)

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Active ingredient:
TIOCONAZOLE (UNII: S57Y5X1117) (TIOCONAZOLE - UNII:S57Y5X1117)
Available from:
Dolgencorp, LLC
Administration route:
VAGINAL
Prescription type:
OTC DRUG
Therapeutic indications:
Vaginal antifungal
Authorization status:
Abbreviated New Drug Application
Authorization number:
55910-731-54

DG HEALTH TIOCONAZOLE 1- tioconazole ointment

Dolgencorp, LLC

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Dolgencorp, LLC Tioconazole 1 Drug Facts

Active ingredient (in each applicator)

Tioconazole 300 mg (6.5%)

Purpos e

Vaginal antifungal

Us e

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

When using this product

Stop use and ask a doctor if

treats vaginal yeast infections

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

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

if you do not get complete relief ask a doctor before using another product

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 (1-800-222-1222).

Directions

Other information

Inactive ingredients

butylated hydroxyanisole, magnesium aluminum silicate, white petrolatum

Questions or comments?

1-888-309-9030

Consumer Information

1-DOSE TREATMENT

Tioconazole Ointment 6.5%

VAGINAL ANTIFUNGAL

EDUCATIONAL BROCHURE

Please read this educational brochure completely before using this product.

USE: treats vaginal yeast infections

1 THIS PRODUCT CURES MOST RECURRENT VAGINAL YEAST INFECTIONS

IF THIS IS THE FIRST TIME YOU HAVE HAD VAGINAL ITCH AND DISCOMFORT,

CONSULT YOUR DOCTOR. IF YOU HAVE HAD A DOCTOR DIAGNOSE A VAGINAL

YEAST INFECTION BEFORE AND HAVE THE SAME SYMPTOMS NOW, USE THIS

OINTMENT AS DIRECTED. THIS PRODUCT IS FOR THE TREATMENT OF

RECURRENT VAGINAL YEAST INFECTIONS ONLY. IT DOES NOT TREAT OTHER

INFECTIONS AND DOES NOT PREVENT PREGNANCY.

before using this product, read the enclosed brochure and instructions on printed packet for

complete directions and information

adults and children 12 years of age and over:

open the printed 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

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

This product, a vaginal ointment that contains an antifungal medicine, works to cure most recurrent

vaginal yeast infections by killing the overgrowth of yeast.

2 WHAT IS A VAGINAL YEAST INFECTION (CANDIDIASIS)?

A yeast infection is caused by an organism called Candida, which is a type of yeast. Healthy women

usually have this yeast in the vagina. Either an overgrowth or rapid growth of this yeast can cause a

vaginal yeast infection. The symptoms of a vaginal yeast infection can include any or all of the

following:

NOTE: Vaginal discharge that is different from the above, for example, a yellow/green discharge or a

discharge that smells "fishy" (foul-smelling), may indicate that you have something other than a yeast

infection. If this is the case, you should consult your doctor before using this product.

3 WHAT ARE THE REASONS YOU GET VAGINAL YEAST INFECTIONS?

There are several conditions that can cause too much yeast to grow inside the vagina such as:

Vaginal itching – Itching can range from mild to intense.

Vaginal discharge – This discharge may be thick like paste or lumpy like cottage cheese.

Vaginal soreness, burning or irritation – The vagina can feel sore inside or there can be a

burning sensation, particularly during vaginal intercourse.

Rash or redness – Rash or redness may occur around the vagina (vulvar irritation).

Hormonal changes – Changes in hormonal levels can occur during pregnancy, with the use of

some birth control pills, and just before a woman's menstrual period.

Antibiotics – Because antibiotics can kill the normal bacteria in the vagina, yeast may grow very

quickly.

Diabetes – Diabetes can also make a woman more likely to get a vaginal yeast infection.

Human Immunodeficiency Virus (HIV) – Various medical conditions can damage the body's

normal defenses against infection. One of the most serious of these conditions is infection with

the human immunodeficiency virus (HIV -the virus that causes AIDS). Infection with HIV causes

the body to be more susceptible to infections, including vaginal yeast infections. Women with HIV

infection may have frequent vaginal yeast infections or, especially, vaginal yeast infections that do

not clear up easily with proper treatment. If you may have been exposed to HIV and are

experiencing either frequent recurring vaginal yeast infections or, especially, vaginal yeast

infections that do not clear up easily with proper treatment, you should see your doctor promptly.

If you wish further information on risk factors for HIV infection or on the relationship between

recurrent or persistent vaginal yeast infections and HIV infection, please contact your doctor or

the CDC National AIDS HOTLINE. The CDC phone numbers are: 1-800-232-4636

(English/Spanish), or 1-888-232-6348 (hearing impaired, TTY).

4 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

When using this product

Stop use and ask a doctor if

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 (1-800-222-1222).

5 WHEN CAN YOU EXPECT SYMPTOM RELIEF?

While this product is a 1-dose treatment, most women do not experience complete relief of their

symptoms in just 1 day. Most women experience some improvement within 1 day and complete relief of

symptoms within 7 days.

If your symptoms do not improve in 3 days or if you still have symptoms after 7 days, consult your

doctor. Your doctor may recommend other treatment, or you may have a condition other than a yeast

infection.

If your symptoms return within 2 months or if you think you have been exposed to the human

immunodeficiency virus (HIV) that causes AIDS, consult your doctor immediately. Recurring yeast

infections may be a sign of pregnancy or a serious condition, such as AIDS or diabetes.

6 HOW TO USE TIOCONAZOLE OINTMENT 6.5%

This product comes in a pre-filled, single-dose applicator.

Directions for use:

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

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

if you do not get complete relief ask a doctor before using another product

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

Read the full directions printed below and on the printed packet carefully before using.

Bedtime is the best time to apply this product.

Bedtime is the best time to apply this product.

Open the printed packet just before use.

Remove the applicator and plunger from the printed packet. The applicator is pre-filled with

vaginal ointment.

While firmly holding the purple-capped end of the applicator, push the tip of the plunger into the

base of applicator. Fig. 1

REMOVE PURPLE CAPfrom the top of the applicator using a pull-twist action. Fig. 2

Lie on your back with your knees bent. Gently insert applicator into the vagina as far as it will go

comfortably. Fig. 3

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. Fig. 4

7 ADVERSE REACTIONS (SIDE EFFECTS)

A temporary increase in vaginal burning, itching and/or irritation may be experienced upon insertion of

this ointment. These reactions, in addition to vaginal swelling or redness; difficulty or burning on

urination; headache; abdominal pain/cramping and upper respiratory infection have been reported with

the use of this product. If you experience any of these, consult your doctor.

8 COMMON QUESTIONS ABOUT VAGINAL YEAST INFECTIONS AND TIOCONAZOLE

OINTMENT 6.5%

Q. Should I use this product while I have my period?

You should use this product while menstruating but you should not use tampons following application.

Use sanitary napkins instead.

Q. Can I have sex while using this product?

It is generally recommended not to have vaginal intercourse the first few nights after treatment with this

product.

Q. Can I use a condom or diaphragm while using this product?

No. This product contains petrolatum which may damage the latex from which condoms and diaphragms

are made and may cause them to fail. This may reduce their effectiveness in preventing sexually

transmitted diseases and pregnancy. You should wait 3 days after treatment to resume using condoms or

your diaphragm.

Q. Does my partner need to be treated?

Yeast infections occur less frequently in men than in women. However, if your partner has any of the

following symptoms: itching, redness or discomfort in the genital area, he should see a doctor and

mention that you are treating a vaginal yeast infection.

Q. Can I use feminine hygiene products (such as douche) while I have a vaginal yeast infection?

It is best not to use any vaginal preparations while you have a yeast infection including douches,

feminine hygiene sprays, contraceptive foams, inserts, or jellies.

9 FOR BEST RESULTS

DO NOT USE TAMPONS while using this medicine. Use sanitary napkins instead.

Wear cotton underwear and loose-fitting clothes – Yeast grow in warm, moist environments.

Wearing loose-fitting, cotton clothes helps create a cooler environment, which makes it more

difficult for yeast to grow.

Change out of a wet bathing suit quickly – Dampness is more likely to encourage the growth of

yeast.

If you have any other questions or concerns about vaginal yeast infections or of a medical nature, don't

hesitate to consult your doctor.

If you have questions or comments about this product, call our toll-free number 1-800-719-9260.

CONTENTS

Active ingredient: Tioconazole 300 mg (6.5% per applicator).

Inactive ingredients: Butylated hydroxyanisole, magnesium aluminum silicate and white petrolatum.

Store at 20°-25°C (68°-77°F).

Do not use if printed packet is torn, open, or incompletely sealed.

For expiration date and lot number, see carton end flap and applicator printed packet.

Distributed By

Perrigo®

Allegan, MI 49010

: 42600 00 J4

Principal Display Panel

1-Dose Treatment

Educational Brochure Enclosed

1-Dose Treatment with 1 Pre-Filled ointment Applicator

Compare to the active ingredient of Monistat

1-Dose Treatment

Tioconazole 1

Tioconazole Ointment 6.5%

Vaginal Antifungal

Cures Most Vaginal Yeast Infections

1 Pre-Filled Applicator

Odorless Formula

NET WT 4.6 g (0.16 OZ)

Use proper hygiene – Wipe from front to rear (away from vagina) after a bowel movement or

urination.

Discuss with your doctor any medication you are now taking – Certain types of medication can

make your vagina more prone to infection.

DG HEALTH TIOCONAZOLE 1

tioconazole ointment

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:559 10 -731

Route of Administration

VAGINAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

TIO CO NAZO LE (UNII: S57Y5X1117) (TIOCONAZOLE - UNII:S57Y5X1117)

TIOCONAZOLE

6 .5 g in 10 0 g

Inactive Ingredients

Ingredient Name

Stre ng th

BUTYLATED HYDRO XYANISO LE (UNII: REK49 6 0 K2U)

MAGNESIUM ALUMINUM SILICATE (UNII: 6 M3P6 4V0 NC)

PETRO LATUM (UNII: 4T6 H12BN9 U)

Product Characteristics

Color

BROWN (light to dark tan)

S core

S hap e

S iz e

Flavor

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date Marketing End Date

1

NDC:559 10 -731-54 1 in 1 CARTON

0 3/0 1/20 19

1

1 in 1 POUCH

1

4.6 g in 1 APPLICATOR; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA0 759 15

0 3/0 1/20 19

Labeler -

Dolgencorp, LLC (068331990)

Dolgencorp, LLC

Revised: 3/2019

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