Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 174e48ed-8d7a-89ad-e063-6294a90a45ec
Route
OPHTHALMIC
Published
Effective Date 2010-06-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Poloxamer 407 (0.1 mg)
Inactive Ingredients
Water

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2024-04-30

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. No necessary. separate daily cleaner STEP 2: Remove surface debris by rinsing thoroughly with Dream Eye STEP 3: Place cleaned contact lens in the lens case and fill with fresh Dream Eye MPS. Soak at least 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 from soft contact lenses. Destroys harmful micro-organisms on the surface of the lens. Rinse, stores and rewets lenses before insertion. For dissolving of Enzymatic 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 daily and 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 Dream Eye, do not use this product. WARNING: 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. ☞ To avoid contamination, do not touch tip of container to any surface. Replace cap after 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 less than when lens wasfirst placed on the eye, feeling of something in the eye (foreign body, 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 t he 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 stops and the lens appears undamaged, thoroughly clean, rinse, and disinfect the lens, then reinsert it. ☞ If the problem continues, IMMEDIATELY remove the lens 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 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 to air dry. DIRECTIONS: ☞ After removing the lens, place it in the palm of your hand, and place three drops of Daily 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 forefinger of the other hand, or between the thumb and forefinger. Be sure to clean each side of the lens. ☞ Rinse the lens thoroughly by holding the lens in a steady stream of saline solution for approximately 10 seconds. ☞ Disinfect using the procedure which your practitioner has recommended.


Medication Information

Warnings and Precautions

only for opthalmic use

Indications and Usage

for opthalmic use

Dosage and Administration

for opthalmic use only

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. No



necessary. separate daily cleaner



STEP 2:



Remove surface debris by rinsing thoroughly with Dream Eye



STEP 3:



Place cleaned contact lens in the lens case and fill with fresh Dream Eye MPS. Soak at



least 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 from



soft contact lenses. Destroys harmful micro-organisms on the surface of the



lens. Rinse, stores and rewets lenses before insertion. For dissolving of



Enzymatic 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 daily



and 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 Dream



Eye, do not use this product.



WARNING: 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.



☞ To avoid contamination, do not touch tip of container to any surface. Replace cap



after 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 less



than when lens wasfirst placed on the eye, feeling of something in the eye (foreign



body, 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 t



he 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 stops



and the lens appears undamaged, thoroughly clean, rinse, and disinfect the lens,



then reinsert it.



☞ If the problem continues, IMMEDIATELY remove the lens



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 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 to



air dry.



DIRECTIONS:



☞ After removing the lens, place it in the palm of your hand, and place three drops of



Daily 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 forefinger



of the other hand, or between the thumb and forefinger. Be sure to clean each side



of the lens.



☞ Rinse the lens thoroughly by holding the lens in a steady stream of saline solution



for approximately 10 seconds.



☞ Disinfect using the procedure which your practitioner has recommended.

Section 50565-1

keep our of reach of children

Section 51727-6

water

Section 51945-4

Active Ingredient: Poloxamer 407

Section 55105-1

for opthalmic use

Section 55106-9

POLOXAMER 407


Structured Label Content

Indications and Usage (34067-9)

for opthalmic use

Dosage and Administration (34068-7)

for opthalmic use only

Warnings and Precautions (34071-1)

only for opthalmic use

Description (34089-3)

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. No



necessary. separate daily cleaner



STEP 2:



Remove surface debris by rinsing thoroughly with Dream Eye



STEP 3:



Place cleaned contact lens in the lens case and fill with fresh Dream Eye MPS. Soak at



least 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 from



soft contact lenses. Destroys harmful micro-organisms on the surface of the



lens. Rinse, stores and rewets lenses before insertion. For dissolving of



Enzymatic 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 daily



and 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 Dream



Eye, do not use this product.



WARNING: 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.



☞ To avoid contamination, do not touch tip of container to any surface. Replace cap



after 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 less



than when lens wasfirst placed on the eye, feeling of something in the eye (foreign



body, 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 t



he 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 stops



and the lens appears undamaged, thoroughly clean, rinse, and disinfect the lens,



then reinsert it.



☞ If the problem continues, IMMEDIATELY remove the lens



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 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 to



air dry.



DIRECTIONS:



☞ After removing the lens, place it in the palm of your hand, and place three drops of



Daily 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 forefinger



of the other hand, or between the thumb and forefinger. Be sure to clean each side



of the lens.



☞ Rinse the lens thoroughly by holding the lens in a steady stream of saline solution



for approximately 10 seconds.



☞ Disinfect using the procedure which your practitioner has recommended.

Section 50565-1 (50565-1)

keep our of reach of children

Section 51727-6 (51727-6)

water

Section 51945-4 (51945-4)

Active Ingredient: Poloxamer 407

Section 55105-1 (55105-1)

for opthalmic use

Section 55106-9 (55106-9)

POLOXAMER 407


Advanced Ingredient Data


Raw Label Data

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