NDC 0065-1432 Systane Ultra

Polyethylene Glycol 400 And Propylene Glycol

NDC Product Code 0065-1432

NDC 0065-1432-04

Package Description: 5 VIAL in 1 CARTON > .7 mL in 1 VIAL

NDC 0065-1432-05

Package Description: 60 VIAL in 1 CARTON > .7 mL in 1 VIAL

NDC 0065-1432-06

Package Description: 25 VIAL in 1 CARTON > .7 mL in 1 VIAL

NDC Product Information

Systane Ultra with NDC 0065-1432 is a a human over the counter drug product labeled by Alcon Laboratories, Inc.. The generic name of Systane Ultra is polyethylene glycol 400 and propylene glycol. The product's dosage form is solution/ drops and is administered via ophthalmic form.

Labeler Name: Alcon Laboratories, Inc.

Dosage Form: Solution/ Drops - A solution which is usually administered in a drop-wise fashion.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Systane Ultra Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • POLYETHYLENE GLYCOL 400 4 mg/mL
  • PROPYLENE GLYCOL 3 mg/mL

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
  • BORIC ACID (UNII: R57ZHV85D4)
  • GUAR GUM (UNII: E89I1637KE)
  • POTASSIUM CHLORIDE (UNII: 660YQ98I10)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • SORBITOL (UNII: 506T60A25R)
  • HYDROCHLORIC ACID (UNII: QTT17582CB)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Ophthalmic - Administration to the external eye.
  • Ophthalmic - Administration to the external eye.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Alcon Laboratories, Inc.
Labeler Code: 0065
FDA Application Number: part349 What is the FDA Application Number?
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.

Marketing Category: OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/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.

Start Marketing Date: 07-27-2009 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Systane Ultra Product Label Images

Systane Ultra Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredients

Active IngredientsPurposePolyethylene Glycol 400 0.4%LubricantPropylene Glycol 0.3%Lubricant

Uses

For the temporary relief of burning and irritation due to dryness of the eye

Warnings

For external use only.

Do Not Use

  • If this product changes color or becomes cloudyif you are sensitive to any ingredient in this product

When Using This Product

  • Do not touch tip of container to any surface to avoid contaminationdo not reuseonce opened, discard

Stop Use And Ask A Doctor If

  • You feel eye painchanges in vision occurredness or irritation of the eye(s) gets worse, persists or lasts more than 72 hours

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Instill 1 or 2 drops in the affected eye(s) as needed.

Other Information

  • Store at room temperature

Inactive Ingredients

Aminomethylpropanol, boric acid, hydroxypropyl guar, potassium chloride, purified water, sodium chloride, sorbitol. May contain hydrochloric acid and/or sodium hydroxide to adjust pH.

Questions?

In the U.S. call 1-800-757-9195www.systane.com

* Please review the disclaimer below.