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Logo POLYCLENS® Suspension

SCHEDULING STATUS:
Not scheduled

PROPRIETARY NAME
(and dosage form):

POLYCLENS® Suspension

COMPOSITION:
Contains 10 g
polymeric beads per 100 mL.
Preserved with thimerosal 0,004% (m/v) and edetate disodium 0,1% (m/v).

PHARMACOLOGICAL CLASSIFICATION:
A 34. Contact lens preparations.

PHARMACOLOGICAL ACTION:
POLYCLENS
® is specially formulated to clean lenses from protein and other hard to remove deposits which interfere with wearing comfort and clear vision. It contains polymeric beads which break up any or tenacious chemical bonds which are holding lipoidal or proteinaceous deposits.

INDICATIONS:
Daily cleaning of soft, hard and gas permeable lenses.

CONTRA-INDICATIONS:
None.

DOSAGE AND DIRECTIONS FOR USE:
Follow the lens care procedures recommended by your lens care professional. Before handling lenses, wash your hands with a non-cosmetic soap and rinse thoroughly, dry hands with a lint-free towel. Work with one lens at a time.

1. FOR HARD AND GAS PERMEABLE CONTACT LENSES:
Shake POLYCLENS well prior to use. Remove your lenses and clean by applying 3 drops of POLYCLENS to the lens surface. Rub between your fingers for at least 20 seconds. Be sure to clean each side of the lens. Thoroughly rinse both surfaces of the lens as directed by your practitioner until all traces of POLYCLENS are removed. The lens should feel squeaky clean between your fingers. Pour a few drops of a hard lens soaking and wetting solution in the appropriate well of your lens storage case, and place your lens in the well (concave or inner side up). Pour enough soaking and wetting solution over the lens to make sure it is completely submerged. Screw lens chamber cap on firmly. Before reinsertion of your lens be sure your hands are clean. Insert lens onto the eye directly from the soaking and wetting solution. To reduce awareness, use a cushioning solution before lens insertion. For all day seeing comfort use a wetting solution.

2. FOR SOFT CONTACT LENSES:
Shake POLYCLENS well. Remove your lenses and clean by applying 3 drops of POLYCLENS to the lens surface. Rub between your fingers for at least 20 seconds. Be sure to clean each side of the lens. Thoroughly rinse both surfaces of the lens with a soft lens rinsing solution or as directed by your contact lens care specialist until all traces of POLYCLENS are removed. Pour a few drops of disinfecting solution in the appropriate well of your lens storage case, and place your lens in the well (concave or inner side up). Pour enough of this solution over the lens to be sure it is completely submerged. Screw lens chamber cap on firmly. Allow the lenses to remain stored for a minimum of four hours to ensure disinfection. Lenses can be carried safely in the lens storage case wherever you go. Before reinsertion of your lenses be sure your hands are clean. Flush the lens with fresh lens rinsing solution and insert lens onto the eye. After lens insertion, rinse the lens storage case out with hot water and dry with a lint-free towel. Use a wetting solution to rewet your lenses to ensure all day seeing comfort.

WARNING:
Never reuse the storage (or disinfecting) solution.

SIDE EFFECTS AND SPECIAL PRECAUTIONS:
If irritation develops, discontinue use and consult your practitioner. No finality has been reached on the long-term safety of soft contact lens preparations.

PRECAUTIONS:
1. It is essential to shake the POLYCLENS bottle thoroughly prior to each use.
2. POLYCLENS must be thoroughly rinsed from the lens prior to disinfection.
3. Lenses must always be THOROUGHLY RINSED AND DISINFECTED after each cleaning procedure.
4. Never place lenses directly in your eye from cleaning solution.
5. Never place POLYCLENS directly in your eye.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
See side effects above.

IDENTIFICATION:
A sterile, milky white suspension.

PRESENTATION:
15 mL Drop-Tainer filled to 12 mL or 30 mL Drop-Tainer filled to 24 mL to allow for shaking.

STORAGE INSTRUCTIONS:
Store at room temperature below 25°C.
Keep out of reach of children.

REGISTRATION NUMBER:
R/34/64

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Alcon Laboratories (SA) (Pty) Ltd.
Surrey Avenue, RANDBURG 2194

DATE OF PUBLICATION OF THE PACKAGE INSERT:
15 June 1994.

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