IW3300 Rectal Foam or PLACEBO

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This Instructions for Use contains information on how to administer investigational product IW-3300 or Placebo.

Important Information You Need to know Before Administering IW-3300 or Placebo

Wash your hands before and after usage

You should empty your bowels before each dose, if possible

Dose Administration
(Repeat steps 3-14 each day for 21 days)

Canister Return

After all 21 doses are used, place the used canister back into its box and return to the clinic at your next study visit.

Kit Contents:

Each kit contains:

product canister. Store canister in the refrigerator until it is opened and used for the first time.

trays (7 plastic applicator tubes per tray for a total of 21) of pre-lubricated single use applicator tubes. Store at room temperature.

21 applicator tube throw away bags. Store at room temperature.

Caution: Product canister is flammable. Always store/use the product canister away from open flame and heat.

Preparing to Administer IW-3300 or Placebo

STEP 01:

Remove one canister box from the refrigerator. For your comfort, keep at room temperature for 30 minutes before use.

Please keep the box after opening and return it to the clinic with the used canister.

STEP 02:

Remove the plastic flap (or safety lock) from underneath the dome-shaped pump at the top of the canister.

STEP 03:

Twist the dome on the top of the canister until the rounded gap underneath is in line with the nozzle. The canister is now ready for use.

STEP 04:

Hold the canister in a vertical position and shake vigorously in an up and down motion from shoulder level to waist level for about 15 seconds.

STEP 05:

Attach applicator tube to the nozzle of the canister.

STEP 06:

Place your index finger on top of the dome and turn the canister upside down, pointing the dome down.

Before the first use, prime the canister by pressing the dome down for 5 seconds. This priming dose may be discarded into household trash.

Note: You do not need to prime the canister with every use. The only time you will prime the canister is the first time you are using the canister. DO NOT prime for other doses.

STEP 07:

Stand and keep one foot on the floor and raise the other foot on a firm surface such as a chair or a stool.

STEP 08:

Gently insert the tip of the applicator tube into the rectum as far as it can comfortably go.

STEP 09:

Using the index finger fully push the dome down and hold down for at least 5 seconds.

STEP 10:

Release the finger pressure on the dome very slowly (3 to 5 seconds) to release the foam.

STEP 11:

Hold applicator tube in place for 10 to 15 seconds and then slowly remove from the rectum. Do this slowly to prevent leakage.

STEP 12:

Remove the applicator tube from the nozzle of canister and put the tube in the throw away bag. This can go in household trash.

Storing IW-3300 or Placebo

STEP 13:

Twist the dome on the top of the canister to lock the device.

Store in a secure location at room temperature.


- Refrigerate and prime the canister only before first use - Use a new applicator for each dose
- After all 21 doses are used, return canister to the clinic.

Return to Step 01 and start a new canister to continue the study.