Properties
What is it?
Product Name: Systane™ COMPLETE Lubricant Eye Drops Composition: Systane™ COMPLETE Lubricant Eye Drops is a sterile white emulsion containing Propylene Glycol, Hydroxypropyl Guar, Mineral Oil, Dimyristoyl Phosphatidylglycerol, Polyoxyl 40 Stearate, Sorbitan Tristearate, Boric Acid, Sorbitol, Edetate Disodium, Polyquad™ (Polyquaternium-1) 0.001% preservative, and Purified Water. May contain Hydrochloric Acid and/or Sodium Hydroxide to adjust pH. Systane™ COMPLETE Lubricant Eye Drops is naturally white in appearance prior to use. Clinical Benefit: When used as directed, Systane™ COMPLETE Lubricant Eye Drops: * Protects the eye surface. * Enhances vision. * Helps restore the health of the eye surface. * Relieves symptoms of dry eye. Indication (Uses): Systane™ COMPLETE Lubricant Eye Drops is indicated for the temporary relief of burning and irritation due to dryness of the eye. Intended Use/Users: Systane™ COMPLETE Lubricant Eye Drops is intended for use by the consumer for the temporary relief of symptoms of dry eye. It may also be used to relieve symptoms of dry eye associated with contact lens wear by instilling prior to contact lens insertion and after contact lens removal. Mechanism of Action: Based on the totality of clinical studies, clinical literature, and market experience (post-market surveillance) data, Systane™ COMPLETE Lubricant Eye Drops work for the temporary relief of burning and irritation due to dryness of the eye. Directions: * Shake well before use. * Systane™ COMPLETE Lubricant Eye Drops may be used as needed throughout the day to relieve symptoms of dry eye. It may be used to relieve symptoms of dry eye associated with contact lens wear by instilling prior to contact lens insertion and after contact lens removal. * Instill 1 or 2 drops in the affected eye(s) as needed and blink. Contraindications (Reasons for Not Using): Do not use this product if you are allergic to any of the ingredients in Systane™ COMPLETE Lubricant Eye Drops. Warnings: It is essential that you follow your eye care professional's instructions and the labeled instructions for proper product use. If you experience persistent eye discomfort, excessive tearing, headaches, changes in vision, or redness of the eyes, discontinue use of Systane™ COMPLETE Lubricant Eye Drops and consult your eye care professional, as the problem may become more serious. Temporary blurred vision or other visual disturbances may affect your ability to drive or operate machinery. If your vision becomes blurred after use, wait until your vision is clear before driving or operating machinery. Precautions: For ophthalmic use only. Tamper-Evident Feature: Do not use if the tamper-evident cap is damaged or missing. Do not use if the packaging or bottle (sterile packaging) is damaged. To avoid contamination, never touch the dropper tip of the container to any surface. If swallowed, get medical help. Do not use if the emulsion changes color. Replace cap after use. Keep tightly closed when not in use. This product contains an amount of boric acid that is safe when used as directed on the label. Use before the expiration date marked on the product. 300049679-0821 When the bottle is opened, discard any remaining emulsion according to the instructions below: * For 1.5 mL and 3 mL sizes, discard the remaining solution after three months. * For 5 mL and 10 mL sizes, discard the remaining solution after six months. Store at temperatures between 2°C and 30°C. Keep out of reach of children. Adverse Reactions (Possible Problems and What to Do): If you experience persistent eye discomfort, excessive tearing, changes in vision, or redness of the eyes, discontinue use of Systane™ COMPLETE Lubricant Eye Drops and consult your eye care professional, as the problem may become more serious. Dosage Form: Drops are available in plastic bottles ranging in size from 1.5 mL to 10 mL.