Label: DREAM EYE- poloxamer 407 liquid

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

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Drug Label Information

Updated October 13, 2010

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  • ACTIVE INGREDIENT

    Active Ingredient: Poloxamer 407
  • DESCRIPTION

    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.
  • WHEN USING

    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.
  • PRECAUTIONS

    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.
  • PURPOSE

    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.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of the reach of children
  • INDICATIONS & USAGE

    INDICATIONS(Uses): Dream Eye is indicated for use in daily cleaning,
    dissolving of Enzymatic 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.
  • INACTIVE INGREDIENT

    Inactive ingredient: Sodium Chloride, Sodium Borate, Boric Acid, HYPROMELLOSES, EDETATE DISODIUM, Water
  • PRINCIPAL DISPLAY PANEL

    package label
  • INGREDIENTS AND APPEARANCE
    DREAM EYE 
    poloxamer 407 liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52345-3001
    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:52345-3001-140 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other10/13/2010
    Labeler - K&J.C Co., Ltd (690257639)
    Registrant - K&J.C Co., Ltd (690257639)
    Establishment
    NameAddressID/FEIBusiness Operations
    K&J.C Co., Ltd690257639manufacture
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