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| Product NDC Code | 0065-1433 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Systane balance |
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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 Ingredient 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
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients: boric acid, dimyristoyl phosphatidylglycerol, edetate disodium, hydroxypropyl guar, mineral oil, polyoxyl 40 stearate, POLYQUAD ® (polyquaternium-1) 0.001% preservative, 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 use as a lubricant to prevent further irritation or to relive dryness of the eye
Purpose
Information about the drug product’s indications for use.Active Ingredient Purpose Propylene Glycol 0.6% Lubricant
| Propylene Glycol 0.6% | Lubricant |
Spl product data elements
Usually a list of ingredients in a drug product.Systane Balance propylene glycol Propylene Glycol Propylene Glycol Boric Acid Dimyristoylphosphatidylglycerol, Dl- Edetate Disodium Guar Gum Mineral Oil Polyoxyl 40 Stearate Sorbitan Tristearate Sorbitol Water Hydrochloric Acid Sodium Hydroxide Polidronium Chloride Systane Balance Carton Label 2x10 mL Carton 10 mL 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 Systane ® LUBRICANT EYE DROPS BALANCE Restoring Dry Eye Relief Locks in moisture Tear evaporation protection Clinically proven DOCTOR RECOMMENDED #1 BRAND 1 Alcon STERILE 10 mL (1/3 FL OZ) LOT: EXP.: SIDE PANEL TAMPER EVIDENT: For your protection, this bottle has an imprinted seal around the neck. Do not use if seal is damaged or missing at time of purchase. www.alconpatents.com Made in USA from domestic and imported materials Systane ® BALANCE Lubricant Eye Drops restores the natural tear’s lipid layer to lock in moisture and protect against tear evaporation. ACTUAL SIZE Alcon Alcon Laboratories, Inc. Fort Worth, TX 76134 USA 1 Based on a survey of eye care professionals. Data on file. 300048644-0521
PRINCIPAL DISPLAY PANEL TWIN PACK Systane ® LUBRICANT EYE DROPS BALANCE Restoring Dry Eye Relief Locks in moisture Tear evaporation protection Clinically proven DOCTOR RECOMMENDED #1 BRAND 1 Alcon STERILE Two 10 mL (1/3 FL OZ) Bottles LOT: EXP.: SIDE PANEL TAMPER EVIDENT: For your protection, this bottle has an imprinted seal around the neck. Do not use if seal is damaged or missing at time of purchase. www.alconpatents.com Made in USA from domestic and imported materials Systane ® BALANCE Lubricant Eye Drops restores the natural tear’s lipid layer to lock in moisture and protect against tear evaporation. ACTUAL SIZE Alcon Alcon Laboratories, Inc. Fort Worth, TX 76134 USA 1 Based on a survey of eye care professionals. Data on file. 300037158-0420
PRINCIPAL DISPLAY PANEL Systane ® LUBRICANT EYE DROPS BALANCE Restoring Dry Eye Relief STERILE 10 mL (1/3 FL OZ) INGREDIENTS: Active: Propylene Glycol 0.6%. Inactives: Boric acid, dimyristoyl phosphatidylglycerol, edetate disodium, hydroxypropyl guar, mineral oil, polyoxyl 40 stearate, POLYQUAD ® (polyquaternium-1) 0.001% preservative, sorbitan tristearate, sorbitol and purified water. May contain hydrochloric acid and/or sodium hydroxide to adjust pH. Store at room temperature. FOR EXTERNAL USE ONLY USES : See carton for USES. WARNINGS : See carton for WARNINGS. DIRECTIONS : Shake well and put 1 or 2 drops in the affected eye(s) as needed. Alcon Alcon Laboratories, Inc. Fort Worth, TX 76134 USA
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.Drug Facts
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 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 [email protected] www.systane.com
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 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