Label: NATURAL CARE- poloxamer 407 liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated October 5, 2010

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  • 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

    package label
  • INGREDIENTS AND APPEARANCE
    NATURAL CARE 
    poloxamer 407 liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52345-2001
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POLOXAMER 407 (UNII: TUF2IVW3M2) (POLOXAMER 407 - UNII:TUF2IVW3M2) POLOXAMER 4070.1 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM BORATE (UNII: 91MBZ8H3QO)  
    BORIC ACID (UNII: R57ZHV85D4)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52345-2001-1150 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other10/05/2010
    Labeler - K&J.C Co., Ltd (690257639)
    Registrant - K&J.C Co., Ltd (690257639)
    Establishment
    NameAddressID/FEIBusiness Operations
    K&J.C Co., Ltd690257639manufacture