FDA Label for Dream Eye
View Indications, Usage & Precautions
Dream Eye Product Label
The following document was submitted to the FDA by the labeler of this product K&j.c Co., Ltd. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Package Label.Principal Display Panel
Active Ingredient: Poloxamer 407
Description
Instructions for use (IFU)Cleans, Rinses, Disinfects, Stores and Removes Protein Daily.All Steps In One Bottle.Directions: To clean, disinfect and remove protein daily, complete these simple steps:STEP 1:Place 3 drops of Dream Eye on each side of contact lens and rub for 20 seconds. Nonecessary. separate daily cleanerSTEP 2:Remove surface debris by rinsing thoroughly with Dream EyeSTEP 3:Place cleaned contact lens in the lens case and fill with fresh Dream Eye MPS. Soak atleast four(4) hours.CONTENTS: Dream Eye is a sterile, isotonic, buffered solution that contains poloxamer,sodium borate, sodium chloride; preserved with Polyhexamethylenebiguanide.ACTIONS: Cleans, loosens and removes accumulations of film, deposits and debris fromsoft contact lenses. Destroys harmful micro-organisms on the surface of thelens. Rinse, stores and rewets lenses before insertion. For dissolving ofEnzymatic Contact Lens Cleaner tablets for removal of protein deposits.INDICATIONS(Uses): Dream Eye is indicated for use in daily cleaning, dissolving ofEnzymatic Contact Lens Cleaner tablets, rinsing and storage of dailyand extended wear soft contact lenses and chemical (not heat)disinfection, as recommended by your eye care professional.CONTRAINDICATIONS (Reasons not to use): If you are allergic to any ingredient in DreamEye, do not use this product.WARNING: PROBLEMS WITH CONTACT LENSES AND LENS CARE PRODUCTS COULDRESULT IN SERIOUS INJURY TO THE EYE. It is essential that you follow youreye care practitioner's directions and all labeling instructions for proper useand care of your lenses and lens care products, including the lens case.☞ To avoid contamination, do not touch tip of container to any surface. Replace capafter using.☞ Not intended for use directly in the eye.☞ Not for use with heat(thermal) disinfection.PRECAUTIONS:☞ Never re-use this solution.☞ Keep the 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 childrenADVERSE REACTIONS (Problems and what to do):The following problems may occur: eyes sting, burn or itch (irritation), comfort is lessthan when lens wasfirst placed on the eye, feeling of something in the eye (foreignbody, scratched area), excessive watering (tearing) of the eye, unusual eye secretions,redness of the eye, reduced sharpness of vision (poor visual acuity), blurred vision,rainbows or halos around objects, sensitivity to light (photophobia), or dry eyes.If you notice any of the above:☞ IMMEDIATELY REMOVE YOUR LENSES.☞ If the discomfort or problem stops, then look closely at the lens.☞ If the lens is in any way damaged, DO NOT put the lens back on your eye. Place the lens in the storage case and contact your eye care practitioner.☞ If the lens has dirt, an eyelash, or other foreigh body on it, or the problem stopsand the lens appears undamaged, thoroughly clean, rinse, and disinfect the lens,then reinsert it.☞ If the problem continues, IMMEDIATELY remove the lensand 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 ofthe problem and prompt treatment to avoid serious eye damage.GOOD LENS CARE PRACTICES:☞ Always wash and rinse your hands before you handle your lenses.☞ Clean, rinse and disinfect your lenses each time you remove them.☞ Always handle the same lens, the right or left, first in order to avoid mix-ups.☞ After use, always empty and rinse lens case with fresh rinsing solution and allow toair dry.DIRECTIONS:☞ After removing the lens, place it in the palm of your hand, and place three drops ofDaily Cleaner on each lens surface. or Soak at least four(4) hours in Dream Eye.☞ Rub the lens for 20 seconds either in the palm of your hand using the forefingerof the other hand, or between the thumb and forefinger. Be sure to clean each sideof the lens.☞ Rinse the lens thoroughly by holding the lens in a steady stream of saline solutionfor approximately 10 seconds.☞ Disinfect using the procedure which your practitioner has recommended.
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