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Oxysept® UltraCare Formula

UltraCare Formula with color indicator neutralizing tablets

A disinfecting, neutralizing and storage system for daily and extended wear soft (hydrophilic) contact lenses* in a chemical (not heat) lens care system.  Included in the Oxysept® System is Oxysept® Disinfecting Solution/Neutralizer.

Oxysept® Disinfecting Solution/Neutralizer consists of:

DESCRIPTION (INGREDIENTS)

ACTIONS

INDICATIONS (USES)
Use Oxysept® Disinfecting Solution/Neutralizer to disinfect, neutralize and store your soft (hydrophilic) contact lenses.

*NOTE: This product is not recommended for use with ILLUSIONS® (tefilcon) lenses. Use of this product may cause lens damage.

CONTRAINDICATIONS (REASONS NOT TO USE)
If you are allergic to any ingredient in Oxysept® Disinfecting Solution/Neutralizer, do not use this system.

WARNINGS

PROBLEMS WITH CONTACT LENSES AND LENS CARE PRODUCTS COULD RESULT IN SERIOUS INJURY TO THE EYE. It is essential that you follow your eye care practitioner’s directions and all labeling instructions for proper use and care of your lenses and lens care products, including the lens case. EYE PROBLEMS, INCLUDING CORNEAL ULCERS, CAN DEVELOP RAPIDLY AND LEAD TO LOSS OF VISION. Daily wear lenses are not indicated for overnight wear and should not be worn while sleeping. Clinical studies have shown that the risk of serious adverse reactions is increased when these lenses are worn overnight. Extended wear lenses should be regularly removed for cleaning and disinfection or for disposal and replacement on the schedule prescribed by your eye care practitioner. Clinical studies have shown that there is an increased incidence of serious adverse reactions in extended wear contact lens users as compared to daily wear contact lens users. Studies have also shown that the risk of serious adverse reactions increases the longer extended wear lenses are worn before removal for cleaning and disinfection or for disposal and replacement.

Studies have also shown that smokers had a higher incidence of adverse reactions. It is recommended that contact lens wearers see their eye care practitioner twice each year, or if directed, more frequently.

To avoid contamination, do not touch the tip of the Oxysept® Disinfecting Solution to any surface. Replace cap after using.

PRECAUTIONS

ADVERSE REACTIONS AND WHAT TO DO
The following may occur:

If you notice any of the above symptoms, IMMEDIATELY remove and examine your lenses. If a lens appears to be damaged, do not reapply; consult your eye care practitioner. If the symptom stops and the lenses appear to be undamaged, follow the complete "Directions for Use", below, before reapplying them. If the symptom continues, IMMEDIATELY remove your lenses, discontinue use of all lens care products that contact the eye, and consult your eye care practitioner.

If any of the above symptoms occur, a serious condition such as infection, corneal ulcer, neovascularization, or iritis may be present. Seek immediate professional identification of the problem, and obtain treatment, if necessary, to avoid serious eye damage.

DIRECTIONS FOR USE
Follow the instructions below each time you remove your contact lenses. Always wash, rinse and dry hands with a lint-free towel before handling contact lenses. Always remove the same lens first to avoid mix-ups.

1. Clean and Rinse Your Lenses
Remove and handle one lens at a time. Gently rub each lens with an appropriate daily cleaner. Rinse thoroughly with sterile saline solution. Place the lens in the appropriate basket of the lens holder attached to the cap and close the basket lid. For easy identification, the left lens basket is blue.

2. Disinfect and Neutralize Your Lenses
Fill the Oxysept® Cup to the fill line with Oxysept® Disinfecting Solution. With dry hands, remove one Oxysept® Neutralizing Tablet from the blister card, drop into the solution and immediately place the lens holder containing the lenses into the Oxysept® Cup. Tighten the cap. Gently turn the Oxysept® Cup upside down, then right side up 3 consecutive times to wet the upper surfaces of the cup and the inside of the cap. Make sure that the tablet is in the solution. The Oxysept® Neutralizing Tablet will color the solution pink. This is normal and expected. The pink coloration provides an easy visual reminder that you have added your neutralizing tablet. The color does not indicate that your lenses are neutralized or ready to wear. You must still soak your lenses for a minimum of 6 hours after the addition of the Oxysept® Neutralizing Tablet. You will see a few bubbles or some light bubbling. If the tablet immediately begins to bubble vigorously, causing foam to form on the solution surface, the tablet is neutralizing the solution too quickly for disinfection to take place. Discard the solution and tablet, fill the cup with fresh solution, add another tablet and immediately tighten the cap. Allow the lenses to soak for a minimum of 6 hours to overnight. The delayed-release Oxysept® Neutralizing Tablet will allow disinfection to occur before it neutralizes the solution. During the neutralization process, the tablet will begin to bubble vigorously and will completely dissolve. If the solution is not pink, you have not added an Oxysept® Neutralizing tablet to the solution. Note: In clinical studies a small percentage of patients reported that their lenses appeared slightly pink. This temporary lens coloration does not damage your lenses, and washes away shortly after lens application.

3. Wear
Before removing lenses from the lens case, turn the lens case upside down, to ensure full neutralization of all residual disinfecting solution in the lens case. Then apply the lenses directly to your eyes. If desired, rinse your lenses with sterile saline solution, before lens application. Do not use Oxysept® Disinfecting Solution (hydrogen peroxide) to rinse your lenses before wearing. If you do not intend to wear your lenses immediately after disinfection/neutralization, you may store them in the unopened Oxysept® Cup. Disinfect and neutralize with fresh solution once a week and before applying the lenses to your eyes. To prevent contamination and to help avoid serious eye injury, always empty and rinse cup with sterile rinsing solution and allow to air dry. Once a week, while you are wearing your lenses, fill the Oxysept® Cup with fresh Oxysept® Disinfecting Solution (do not add an Oxysept® Neutralizing Tablet). Tighten the cap. Turn the cup upside down to allow the solution to cover the inside of the cap and the top part of the cup. Leave the cup in this position until you are ready to remove your lenses from your eyes and disinfect.

Note: Once a week, simply add an Ultrazyme® Enzymatic Cleaner tablet to the Oxysept® Disinfecting Solution at the same time that you add the Oxysept® Neutralizing Tablet. You will simultaneously reduce the buildup of protein on your soft (hydrophilic) contact lenses as you disinfect and neutralize them. For more information, see the Ultrazyme® Enzymatic Cleaner package insert, or ask your eye care practitioner.