Terconazole Vaginal Cream

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Use as you have been told, even if your signs get better.
• Do not take terconazole vaginal cream by mouth. For vaginal use only. Keep out of your mouth, nose, and eyes (may burn).
• Wash your hands before use.
• Use at bedtime for best results.
• Wash your hands and applicator after use.

What do I do if I miss a dose?

• Use a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not use 2 doses or extra doses.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Headache.
• Period (menstrual) pain.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Terconazole Vaginal Cream 0.4% is indicated for the local treatment of vulvovaginal candidiasis (moniliasis). As Terconazole Vaginal Cream 0.4% is effective only for vulvovaginitis caused by the genus Candida, the diagnosis should be confirmed by KOH smears and/or cultures.

Patients known to be hypersensitive to terconazole or to any of the components of the cream.

In the rat, the oral LD 50 values were found to be 1,741 and 849 mg/kg for the male and female, respectively. The oral LD 50 values for the male and female dog were ≅1,280 and ≥640 mg/kg, respectively.

In the event of oral ingestion of the cream, supportive and symptomatic measures should be carried out. If the cream is accidentally applied to the eyes, wash with clean water or saline and seek medical attention if symptoms persist.

Terconazole Vaginal Cream 0.4% is available in:

NDC 0168-0346-46     45 gram tube, with a measured dose applicator.

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

E. FOUGERA & CO.
A division of
Fougera
PHARMACEUTICALS INC.
Melville, New York 11747

I2346C
R09/14
#22

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Terconazole Vaginal Cream 0.4%
PATIENT INSTRUCTIONS

Filling the applicator:

1. Remove the cap from the tube. 2. Use the pointed tip on the top of the cap to puncture the seal on the tube. 3. Screw the applicator onto the tube. 4. Squeeze the tube from the bottom and fill the applicator until the plunger stops. 5. Unscrew the applicator from the tube.

Using the applicator:

1. Lie on your back with your knees drawn up toward your chest. 2. Holding the applicator by the ribbed end of the barrel, insert the filled applicator into the vagina as far as it will comfortably go. 3. Slowly press the plunger of the applicator to release the cream into the vagina. 4. Remove the applicator from the vagina. 5. Apply one applicatorful each night for as many days at bedtime, as directed by your doctor.

Cleaning the applicator:

After each use, you should thoroughly clean the applicator by following the procedure below:

1. Pull the plunger out of the barrel. 2. Wash both pieces with lukewarm, soapy water, and dry them thoroughly. 3. Put the applicator back together by gently pushing the plunger into the barrel as far as it will go.

NOTE: Store at 20° to 25°C (68° to 77°F)
[see USP Controlled Room Temperature].
See side flap of carton for lot number and expiration date.

A WORD ABOUT YEAST INFECTIONS

Why do yeast infections occur?

Yeast infections are caused by an organism called Candida (KAN di duh). It may be present in small and harmless amounts in the mouth, digestive tract, and vagina. Sometimes the natural balance of the vagina becomes upset. This may lead to rapid growth of Candida, which results in a yeast infection. Symptoms of a yeast infection include itching, burning, redness, and an abnormal discharge.

Your doctor can make the diagnosis of a yeast infection by evaluating your symptoms and looking at a sample of the discharge under the microscope.

How can I prevent yeast infections?

Certain factors may increase your chance of developing a yeast infection. These factors don't actually cause the problem, but they may create a situation that allows the yeast to grow rapidly.

• Clothing: Tight jeans, nylon underwear, pantyhose, and wet bathing suits can hold in heat and moisture (two conditions in which yeast organisms thrive). Looser pants or skirts, 100% cotton underwear, and stockings may help avoid this problem. • Diet: Cutting down on sweets, milk products, and artificial sweeteners may reduce the risk of yeast infections. • Antibiotics: Antibiotics work by eliminating disease-causing organisms. While they are helpful in curing other problems, antibiotics may lead to an overgrowth of Candida in the vagina. • Pregnancy: Hormonal changes in the body during pregnancy encourage the growth of yeast. This is a very common time for an infection to occur. Until the baby is born, it may be hard to completely eliminate yeast infections. If you believe you are pregnant, tell your doctor. • Menstruation: Sometimes monthly changes in hormone levels may lead to yeast infections. • Diabetes: In addition to heat and moisture, yeast thrives on sugar. Because diabetics often have sugar in their urine, their vaginas are rich in this substance. Careful control of diabetes may help prevent yeast infections.

Controlling these factors can help eliminate yeast infections and may prevent them from coming back.

Some other helpful tips:

1. For best results, be sure to use the medication as prescribed by your doctor, even if you feel better very quickly. 2. Avoid sexual intercourse, if your doctor advises you to do so. 3. If your partner has any penile itching, redness, or discomfort, he should consult his physician and mention that you are being treated for a yeast infection. 4. You can use the medication even if you are having your menstrual period. However, you should not use tampons because they may absorb the medication. Instead, use external pads or napkins until you have finished your medication. You may also wish to wear a sanitary napkin if the vaginal medication leaks. 5. Dry the genital area thoroughly after showering, bathing, or swimming. Change out of a wet bathing suit or damp exercise clothes as soon as possible. A dry environment is less likely to encourage the growth of yeast. 6. Wipe from front to rear (away from the vagina) after a bowel movement. 7. Don't douche unless your doctor specifically tells you to do so. Douching may disturb the vaginal balance. 8. Don't scratch if you can help it. Scratching can cause more irritation and spread the infection. 9. Discuss with your physician any medication you are already taking. Certain types of medication can make your vagina more susceptible to infection. 10. Eat nutritious meals to promote your general health.

KEEP OUT OF THE REACH OF CHILDREN.

E. FOUGERA & CO.
A division of
Fougera
PHARMACEUTICALS INC.
Melville, New York 11747

R09/14

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 45 GRAM TUBE

NDC 0168-0346-46

Fougera®

TERCONAZOLE
VAGINAL CREAM
0.4%

Rx only
WARNING: Keep out of reach
of children.

NET WT 45 grams
Quantity by weight not by volume

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 45 GRAM CARTON

NDC 0168-0346-46

Fougera®

Rx only

TERCONAZOLE
VAGINAL CREAM 0.4%

WARNING: Keep out of reach
of children.

NET WT 45 grams

TERCONAZOLE  terconazole cream

Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0168-0346 Route of Administration VAGINAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TERCONAZOLE (TERCONAZOLE) TERCONAZOLE 4 mg  in 1 g

Inactive Ingredients Ingredient Name Strength BUTYLATED HYDROXYANISOLE   CETYL ALCOHOL   ISOPROPYL MYRISTATE   POLYSORBATE 60   POLYSORBATE 80   PROPYLENE GLYCOL   STEARYL ALCOHOL   WATER

Packaging # Item Code Package Description 1 NDC:0168-0346-46 45 g in 1 TUBE, WITH APPLICATOR

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA076712 02/18/2005

Labeler - E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. (043838424)

Revised: 09/2014   E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.