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Logo OPTI-SOAK pH™ Multi-Purpose Solution

SCHEDULING STATUS:
S0

PROPRIETARY NAME
(and dosage form):

OPTI-SOAK pH™ Multi-Purpose Solution

COMPOSITION:
OPTI-SOAK pH Multi-Purpose Solution is a sterile, aqueous solution buffered to the approximate pH and tonicity of the eye. It contains the hydroxypropyl guar 0.20% (m/v), wetting / conditioning polymer system, polyethylene glycol 400 0.40% (m/v), poloxamine 0.25% (m/v), boric acid 1.00% (m/v), propylene glycol 0.90% (m/v), with POLYQUAD® (polyquaternium-1) 0.0011% (m/v) as preservative and edetate disodium 0.01% (m/v).


PHARMACOLOGICAL CLASSIFICATION
A.34 Contact lens preparation

PHARMACOLOGICAL ACTION
OPTI-SOAK pH Multi-Purpose Solution removes protein and lipids from the lens surface and helps keep deposits from lenses. OPTI-SOAK pHis also used for rinsing lenses, to eliminate loosened surface deposits from the lens. The polymer system cushions the lens upon insertion and provides uniform wetting. It contains a preservative system effective in destroying harmful organisms. OPTI-SOAK pHis effective in cleaning, disinfecting, and conditioning yet it is compatible with ocular tissues upon lens insertion. No separate daily cleaner is required.

INDICATIONS
OPTI-SOAK pHMulti-Purpose Solution is used for the cleaning, disinfecting, conditioning, rinsing and storage of clear and tinted, daily and extended wear fluorosilicone acrylate and silicone acrylate rigid gas permeable lenses.
OPTI-SOAK pH may be used as a diluent for Opti-Plus® Active Cleaner and to rinse lenses before wearing.

CONTRA-INDICATIONS
OPTI-SOAK pHMulti-Purpose Solution is not for use with soft contact lenses.
Do not use for thermal (heat) disinfection.
People allergic to any ingredient in OPTI-SOAK pHshould not use this product.

WARNINGS
It is essential that you follow your eye care practitioner’s directions and all labelling instructions for proper use and care of your lenses and lens care products.

DOSAGE AND DIRECTIONS FOR USE
General directions:
Always wash and rinse your hands before handling your contact lenses.
Always handle one lens, left or right, first in order to avoid mix-ups.
When using a new lens case rinse the case with OPTI-SOAK pHMulti-Purpose Solution or as recommended by your eye care practitioner. Alcon recommends that you replace your lens case on a frequent basis.

Directions for care of your lenses:
Remove each lens and rub both sides of the lens carefully with 2 to 4 drops of OPTI-SOAK pH™ Multi-Purpose Solution or another daily cleaner if recommended by your eye care practitioner. Be sure to clean each side of the lens.
Thoroughly rinse each lens as recommended by your practitioner.
Fill your storage case with enough fresh OPTI-SOAK pH to cover the lenses. Place the lenses in your storage case and check to see that the lenses are completely submerged. Close the storage case tightly.
Leave lenses in your closed storage case overnight or for at least four hours.
Lenses may be removed from the storage case and placed directly into your eyes. For extra cushioning, a drop of OPTI-SOAK pH may be added to the inside of each lens prior to insertion.
After you remove the lenses from the lens case, empty the lens case, rinse the case, and allow it to air dry.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS
Always use fresh OPTI-SOAK pH Multi-Purpose Solution. Never reuse the solution in your lens storage case.
Your lenses must be cleaned and disinfected each time they are removed.
After cleaning as recommended by your eye care practitioner, always rinse lenses thoroughly to eliminate loosened surface deposits.
Do not use soaps, detergents or other household cleaners.
To avoid contamination, never touch the dropper tip of the container to any surface or transfer to other bottles or containers.
Keep container tightly closed when not in use.
Replace cap after use.
Store below 25°C.
Use before the expiration date marked on the container and carton.
Discard remaining solution 6 months after first opening.
Keep out of the reach of children.
If you experience persistent eye discomfort, excessive tearing, vision changes or redness of the eye, IMMEDIATELY remove your lenses and consult your eye care practitioner as the problem could become more serious.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT
See side-effects above.

IDENTIFICATION
A colourless, particle free solution.

PRESENTATION
OPTI-SOAK pHMulti-Purpose Solution is supplied in a white plastic bottle containing 120 mL.

STORAGE INSTRUCTIONS
Store below 25°C.
Use before the expiry date indicated on the product. Do not use if tamper evident seal is broken. Discard remaining solution 6 months after opening.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
37/34/0627

NAME AND BUSINESS ADDRESS OF THE APPLICANT
Alcon Laboratories (SA) (Pty) Ltd
Alcon House
65 Peter Place
Bryanston Extension 13
2191

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
8 April 2005

South African Patent No. 98/6534

0105

New addition to this site: January 2008
Source: Pharmaceutical Industry

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