NATURAL CARE- poloxamer 407 liquid

Natural Care by

Drug Labeling and Warnings

Natural Care by is a Otc medication manufactured, distributed, or labeled by K&J.C Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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. 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.

WHEN USING

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.

INACTIVE INGREDIENT

Inactive ingredient: Sodium Chloride, Sodium Borate, Boric Acid, HYPROMELLOSE, EDETATE DISODIUM, Water

PURPOSE

NDICATIONS(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.

KEEP OUT OF REACH OF CHILDREN

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):

INDICATIONS & USAGE

NDICATIONS(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.

WARNINGS

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.

DOSAGE & ADMINISTRATION

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.

ACTIVE INGREDIENT

Active Ingredient: POLOXAMER 407

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

NATURAL CARE 
poloxamer 407 liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52345-2001
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POLOXAMER 407 (UNII: TUF2IVW3M2) (POLOXAMER 407 - UNII:TUF2IVW3M2)	POLOXAMER 407	0.1 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM BORATE (UNII: 91MBZ8H3QO)
BORIC ACID (UNII: R57ZHV85D4)
HYPROMELLOSES (UNII: 3NXW29V3WO)
EDETATE DISODIUM (UNII: 7FLD91C86K)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52345-2001-1	150 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		10/05/2010

Labeler - K&J.C Co., Ltd (690257639)

Registrant - K&J.C Co., Ltd (690257639)

Establishment
Name	Address	ID/FEI	Business Operations
K&J.C Co., Ltd		690257639	manufacture