HOW SUPPLIED

Metronidazole Vaginal Gel 0.75% is supplied in a 70 gram tube and packaged with 5 vaginal applicators.

The NDC number for the 70 gram tube is 33261-0786-01.

Store at controlled room temperature 15° to 30°C (59° to 86°F). Protect from freezing.

Clinical Studies

In a randomized, single-blind clinical trial of non-pregnant women with bacterial vaginosis who received Metronidazole Vaginal Gel daily for 5 days, the clinical cure rates for evaluable patients determined at 4 weeks after completion of therapy for the QD and BID regimens were 98/185 (53%) and 109/190 (57%), respectively.

Rx only

June 2008

Manufactured for

Prasco Laboratories

Mason, OH 45040 USA

Manufactured by

DPT Laboratories, Inc.

San Antonio, TX 78215

128951-0608

DIRECTIONS FOR USE

1. Filling the applicator

• Remove cap and puncture metal seal on tube with the pointed tip of cap. (See Figure 1)

• Screw end of applicator onto tube. (See Figure 2)

• Gently squeeze the tube from the bottom to fill applicator. Plunger will stop when the applicator is full. (See Figure 3)

• Unscrew applicator and replace cap on tube.




2. Inserting the applicator

• The applicator may be inserted while lying on your back with your knees bent or in any comfortable position.

• Hold filled applicator by barrel, and gently insert into vagina as far as it will comfortably go. (See Figure 4)

• Slowly press the plunger until it stops to deposit gel into vagina and then withdraw the applicator.


3. Care of the applicator

If physician prescribes twice-a-day dosing:

• After use, pull the plunger out of the barrel. (See Figure 5)

• Wash both plunger and barrel in warm soapy water and rinse thoroughly.

• To reassemble applicator, gently push plunger back into barrel.


IMPORTANT:

For once-a-day dosing, apply one applicator full at bedtime. For twice-a-day dosing, apply one applicator full each morning and evening for five days, or as directed by physician.

WARNINGS:

• If significant irritation develops from the use of this medication, discontinue use and consult your physician.

• Do not use during pregnancy except under the supervision of a physician.

• Keep this and all medications out of reach of children.

• For vaginal use only. Not for use in the eyes, on the skin or in the mouth.

Store at room temperature. Avoid exposure to extreme heat or cold.

See end of carton and bottom of tube for lot number and expiration date.


Prasco Laboratories

Mason, OH 45040 USA

Repackaged By :
Aidarex Pharmaceuticals LLC,
Corona, CA 92880

Rev. 06/08

US patent 5,536,743

Printed in USA