Systane Ultra
Polyethylene Glycol 400 And Propylene Glycol
Alcon Laboratories, Inc.
Human Otc Drug
NDC 0065-1432Systane Ultra also known as Polyethylene Glycol 400 And Propylene Glycol is a human otc drug labeled by 'Alcon Laboratories, Inc.'. National Drug Code (NDC) number for Systane Ultra is 0065-1432. This drug is available in dosage form of Solution/ Drops. The names of the active, medicinal ingredients in Systane Ultra drug includes Polyethylene Glycol 400 - 4 mg/mL Propylene Glycol - 3 mg/mL . The currest status of Systane Ultra drug is Active.
Drug Information:
| Drug NDC: | 0065-1432 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Systane Ultra |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Proprietary Name Base: | Systane |
| The base of the Brand/Proprietary name excluding its suffix. |
| Proprietary Name Suffix: | ULTRA |
| A suffix to the proprietary name, a value here should be appended to the ProprietaryName field to obtain the complete name of the product. This suffix is often used to distinguish characteristics of a product such as extended release (“XR”) or sleep aid (“PM”). Although many companies follow certain naming conventions for suffices, there is no recognized standard. |
| Product Type: | Human Otc Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Polyethylene Glycol 400 And Propylene Glycol |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Alcon Laboratories, Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Solution/ Drops |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | POLYETHYLENE GLYCOL 400 - 4 mg/mL
PROPYLENE GLYCOL - 3 mg/mL
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | OPHTHALMIC
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | OTC MONOGRAPH FINAL |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
| Marketing Start Date: | 27 Jul, 2009 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 22 Dec, 2025 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Application Number: | part349 |
| This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | Alcon Laboratories, Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 477589
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UNII: | B697894SGQ
6DC9Q167V3
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 0065-1432-04 | 5 VIAL in 1 CARTON (0065-1432-04) / .7 mL in 1 VIAL | 27 Jul, 2009 | N/A | No |
| 0065-1432-05 | 60 VIAL in 1 CARTON (0065-1432-05) / .7 mL in 1 VIAL | 27 Jul, 2009 | N/A | No |
| 0065-1432-06 | 25 VIAL in 1 CARTON (0065-1432-06) / .7 mL in 1 VIAL | 27 Jul, 2009 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Purpose:
Product Elements:
Systane ultra polyethylene glycol 400 and propylene glycol polyethylene glycol 400 polyethylene glycol, unspecified propylene glycol propylene glycol aminomethylpropanol boric acid guar gum potassium chloride water sodium chloride sorbitol hydrochloric acid sodium hydroxide carton label
Indications and Usage:
Uses for the temporary relief of burning and irritation due to dryness of the eye for temporary relief of discomfort due to minor irritation of the eye or to exposure to wind or sun
Warnings:
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 do not reuse once opened, discard 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.
Do Not Use:
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 do not reuse once opened, discard 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.
When Using:
When using this product do not touch tip of container to any surface to avoid contamination do not reuse once opened, discard
Dosage and Administration:
Directions put 1 or 2 drops in the affected eye(s) as needed.
Stop 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
Package Label Principal Display Panel:
Principal display panel systane ® lubricant eye drops ultra pf preservative-free dry eye relief convenient single vials on-the-go great for sensitive eyes fast-acting hydration and lasting relief moisture-rich formula #1 doctor recommended brand 1 sterile 60 vials 0.7 ml each alcon side display panel systane ® lubricant eye drops ultra pf preservative-free dry eye relief convenient single vials on-the-go open your eyes to a breakthrough in comfort with systane ® ultra lubricant eye drops. systane ® ultra preservative-free vials elevates the science of dry eye therapy to a new level so you can have relief from dry eye anytime, anywhere. from first blink eyes feel lubricated and refreshed. feel the difference in dry eye relief with systane ® ultra tamper evident: do not use if vial is damaged or opened at time of purchase. 1 based on a survey of eye care professionals. data on file. www.alconpatents.com made in france w435221-0919
Further Questions:
Questions? in the u.s. call 1-800-757-9195 www.systane.com