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COMPLETE® Lubricating and Rewetting Drops

For use with soft (hydrophilic) contact lenses, including disposable lenses

DESCRIPTION:
COMPLETE® Lubricating and Rewetting Drops is a sterile, isotonic, buffered, preserved
solution. This aqueous formulation includes purified water, sodium chloride, preserved
with polyhexamethylene biguanide 0.0001%, buffered with tromethamine, hydroxypropyl
methylcellulose as a lubricant, tyloxapol as a surfactant, and edetate disodium as a
chelating agent. This preparation contains no chlorhexidine, no thimerosal and no other
mercury containing ingredients.

ACTIONS:
COMPLETE® Lubricating and Rewetting Drops has been formulated for use with soft
(hydrophilic) contact lenses to rewet lenses before insertion and lubricate lenses
during wear to moisten and reduce lens friction against the cornea. It also relieves
minor irritation, discomfort, dryness, blurring and itchiness which may occur while
wearing your lenses.

INDICATIONS:
COMPLETE® Lubricating and Rewetting Drops is indicated for use to lubricate and rewet
soft (hydrophilic) contact lenses before application and during lens wear.

CONTRAINDICATIONS (REASONS NOT TO USE):
If you are allergic to any ingredient in COMPLETE® Lubricating and Rewetting Drops, do not use this product.

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 dropper tip of the bottle to any surface.
Replace cap after using.

PRECAUTIONS:
Keep bottle tightly closed when not in use. Store at room temperature. Use before the
expiration date marked on the bottle and carton. Keep out of the reach of children.

ADVERSE REACTIONS (POSSIBLE PROBLEMS) AND WHAT TO DO:
The following may occur:
• Eyes stinging, burning, or itching
• Excessive watering (tearing) of the eyes
• Unusual eye secretions
• Redness of the eyes
• Reduced sharpness of vision (visual acuity)
• Blurred vision
• Sensitivity to light (photophobia)
• Dry eyes

If you notice any of the above, IMMEDIATELY remove and examine your lenses.

If a lens appears to be damaged, do not reapply; consult your eye care practitioner. If
the problem stops and the lenses appear to be undamaged, follow the “Directions”
below, before reapplying the lens.

If the problem 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 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:
To lubricate and rewet your lenses and to relieve minor irritation, discomfort, dryness,
blurring and itchiness, apply one or two drops to each eye, up to four times per day, then
blink several times.

If you require more frequent in-the-eye use of COMPLETE® Lubricating and Rewetting
Drops to maintain comfortable lens wear, this may signify a condition that should be
evaluated by your eye care practitioner.

HOW SUPPLIED:
COMPLETE® Lubricating and Rewetting Drops is supplied in sterile 1/2 fl oz plastic
bottles. The bottles are marked with the lot number and expiration date.

COMPLETE® Lubricating and Rewetting Drops

INDICATIONS:
COMPLETE® Lubricating and Rewetting Drops is indicated for use to lubricate and rewet
soft (hydrophilic) contact lenses before application and during lens wear.

CONTRAINDICATIONS (REASONS NOT TO USE):
If you are allergic to any ingredient in COMPLETE® Lubricating and Rewetting Drops, do not use this product.

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 dropper tip of the bottle to any surface.
Replace cap after using.

PRECAUTIONS:
Keep bottle tightly closed when not in use. Store at room temperature. Use before the
expiration date marked on the bottle and carton. Keep out of the reach of children.

ADVERSE REACTIONS (POSSIBLE PROBLEMS) AND WHAT TO DO:
The following may occur:
• Eyes stinging, burning, or itching
• Excessive watering (tearing) of the eyes
• Unusual eye secretions
• Redness of the eyes
• Reduced sharpness of vision (visual acuity)
• Blurred vision
• Sensitivity to light (photophobia)
• Dry eyes

If you notice any of the above, IMMEDIATELY remove and examine your lenses.

If a lens appears to be damaged, do not reapply; consult your eye care practitioner. If
the problem stops and the lenses appear to be undamaged, follow the "Directions"
below, before reapplying the lens.

If the problem 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 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.

COMPLETE<sup>®</sup> Lubricating and Rewetting Drops

COMPLETE® Lubricating and Rewetting Drops lubricates and rewets your soft contact lenses, and relieves minor irritation, discomfort, dryness, blurring and itchiness.

Usage and Directions

To lubricate and rewet your lenses and to relieve minor irritation, discomfort, dryness, blurring and itchiness, apply one or two drops to each eye, up to four times per day, then blink several times.

If you require more frequent in-the-eye use of COMPLETE® Lubricating and Rewetting Drops to maintain comfortable lens wear, this may signify a condition that should be evaluated by your eye care practitioner.

Ingredients

COMPLETE® Lubricating and Rewetting Drops is a sterile, isotonic, buffered, preserved solution. This aqueous formulation includes purified water, sodium chloride, preserved with polyhexamethylene biguanide 0.0001%, buffered with tromethamine, hydroxypropyl methylcellulose as a lubricant, tyloxapol as a surfactant, and edetate disodium as a chelating agent. This preparation contains no chlorhexidine, no thimerosal and no other mercury containing ingredients.

Precautions

  • Wash your hands with soap and water and dry with a lint-free towel before handling your lenses.
  • Keep bottle tightly closed when not in use. Store at room temperature.
  • Use before the expiration date marked on the bottle and carton.
  • Keep out of the reach of children.

Contraindications

If you are allergic to any ingredient in COMPLETE® Lubricating and Rewetting Drops, do not use this product.

Information for consumers

For consumer information on AMO's corneal care products please visit


SUMMARY OF SAFETY INFORMATION

If you are allergic to any ingredient in COMPLETE® Lubricating and Rewetting Drops, do not use this product.
Problems with contact lenses and lens care products could result in serious injury to the eye.  It is essential that you understand contraindications, warnings, precautions, possible adverse reactions carefully and follow your eye care practitioner's directions and all labeling instructions for proper use and care of your contact lenses, lens case, and lens care products. For details, click on important safety information button on top.