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| Product NDC Code | 0065-1509 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Systane complete pf |
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| Type | Brand | ||||||||
| Active Ingredients |
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| Route | OPHTHALMIC | ||||||||
| Dosage Form | EMULSION | ||||||||
| Application Number | M018 | ||||||||
| Labeler Name | Alcon Laboratories, Inc. | ||||||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredients Purpose Propylene Glycol 0.6% Lubricant
| Propylene Glycol 0.6% | Lubricant |
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.Directions shake well before using put 1 or 2 drops in the affected eye(s) as needed see side of carton for directions for use
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients boric acid, dimyristoyl phosphatidylglycerol, hydroxypropyl guar, mineral oil, polyoxyl 40 stearate, sorbitan tristearate, sorbitol and purified water. May contain hydrochloric acid and/or sodium hydroxide to adjust pH.
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Uses for the temporary relief of burning and irritation due to dryness of the eye for the temporary relief of discomfort due to minor irritations of the eye or to exposure to wind or sun for use as a protectant against further irritation or to relieve dryness of the eye for use as a lubricant to prevent further irritation or to relieve dryness of the eye
Spl product data elements
Usually a list of ingredients in a drug product.Systane COMPLETE PF propylene glycol Propylene Glycol Propylene Glycol Boric Acid Dimyristoylphosphatidylglycerol, Dl- Guaraprolose (3500 Mpa.S At 1%) Mineral Oil Polyoxyl 40 Stearate Sorbitan Tristearate Sorbitol Water Hydrochloric Acid Sodium Hydroxide Before First Use Carton Label Carton Label Carton Label
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.PRINCIPAL DISPLAY PANEL Preservative-Free Systane ® LUBRICANT EYE DROPS COMPLETE PF PRESERVATIVE-FREE DRY EYE RELIEF Fast-acting hydration for sensitive eyes Tear evaporation protection Preservative-Free Bottle #1 DOCTOR RECOMMENDED BRAND 1 Alcon Sterile 10mL (0.34 FL OZ) LOT: EXP.: Side Panel: TAMPER EVIDENT: For your protection, this bottle has a tamper evident ring around the bottom of the cap. Do not use if this ring is damaged or missing at the time of purchase. 1 Based on a survey of eye care professionals. Data on file. *vs SYSTANE® BALANCE Lubricant Eye Drops Alcon Laboratories, Inc. Fort Worth, TX 76134 USA Country of Origin United States www.alconpatents.com Actual Size 300059079-1022 PRINCIPAL DISPLAY PANEL TWIN PACK Preservative-Free Systane ® LUBRICANT EYE DROPS COMPLETE PF PRESERVATIVE-FREE DRY EYE RELIEF Fast-acting hydration for sensitive eyes Tear evaporation protection Preservative-Free Bottle #1 DOCTOR RECOMMENDED BRAND 1 Alcon Sterile Two 10mL (0.34 FL OZ) Bottles LOT: EXP.: Side Panel: TAMPER EVIDENT: For your protection, this bottle has a tamper evident ring around the bottom of the cap. Do not use if this ring is damaged or missing at the time of purchase. 1 Based on a survey of eye care professionals. Data on file. *vs SYSTANE® BALANCE Lubricant Eye Drops SYSTANE ® COMPLETE Lubricant Eye Drops hydrates fast, protects against tear evaporation, and helps support all layers of the tear film. Nano droplet technology.* a better delivery of the active ingredient better eye coverage ACTUAL SIZE Alcon Laboratories, Inc. Fort Worth, TX 76134 USA Country of Origin United States www.alconpatents.com 300059078-1022 PRINCIPAL DISPLAY PANEL 3 PACK Preservative-Free Systane ® LUBRICANT EYE DROPS COMPLETE PF PRESERVATIVE-FREE DRY EYE RELIEF Fast-acting hydration for sensitive eyes Tear evaporation protection Preservative-Free Bottle #1 DOCTOR RECOMMENDED BRAND 1 Alcon Sterile Three 10mL (0.34 FL OZ) Bottles LOT: EXP.: Side Panel: TAMPER EVIDENT: For your protection, this bottle has a tamper evident ring around the bottom of the cap. Do not use if this ring is damaged or missing at the time of purchase. 1 Based on a survey of eye care professionals. Data on file. *vs SYSTANE® BALANCE Lubricant Eye Drops SYSTANE ® COMPLETE Lubricant Eye Drops hydrates fast, protects against tear evaporation, and helps support all layers of the tear film. Nano droplet technology.* a better delivery of the active ingredient better eye coverage ACTUAL SIZE Alcon Laboratories, Inc. Fort Worth, TX 76134 USA Country of Origin United States www.alconpatents.com 300059852-1222
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Other Information store at room temperature
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use if this product changes color or becomes cloudy if you are sensitive to any ingredient in this product
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? In the U.S. call 1-800-757-9195 www.systane.com [email protected] Directions for Use: Hold the bottle just below the cap and twist the cap to open. BEFORE FIRST USE , hold the bottle upside down and dispense one drop of product to discard. Shake the bottle downward to remove residual product (see picture). Place 1 or 2 drops in the affected eye(s) as needed and blink. After use, shake the bottle downward to remove residual product that may be left on the tip (see picture on side panel). Replace cap after use. 1 Based on a survey of eye care professionals. Data on file. *vs SYSTANE ® BALANCE Lubricant Eye Drops
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop use and ask a doctor if you experience any of the following: eye pain changes in vision continued redness or irritation of the eye condition worsens or persists for more than 72 hours
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product do not touch tip of container to any surface to avoid contamination replace cap after each use
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.Warnings For external use only Do not use if this product changes color or becomes cloudy if you are sensitive to any ingredient in this product When using this product do not touch tip of container to any surface to avoid contamination replace cap after each use Stop use and ask a doctor if you experience any of the following: eye pain changes in vision continued redness or irritation of the eye condition worsens or persists for more than 72 hours Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API