NDC 0065-1509 Systane Complete Pf
Propylene Glycol Solution/ Drops Ophthalmic

Product Information

Systane Complete Pf is a human over the counter drug product labeled by Alcon Laboratories, Inc.. The generic name of Systane Complete Pf is propylene glycol. The product's dosage form is solution/ drops and is administered via ophthalmic form.

Product Code0065-1509
Proprietary Name What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Systane Complete Pf
Non-Proprietary Name What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Propylene Glycol
Product Type 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.
Human Otc Drug
Dosage FormSolution/ Drops - A solution which is usually administered in a drop-wise fashion.
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.
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.
Alcon Laboratories, Inc.
Labeler Code0065
FDA Application Number 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.
part349
Marketing Category 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.
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
10-01-2021
Listing Expiration Date 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.
12-31-2022
Exclude Flag 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".
N
NDC Code Structure

What are the uses for Systane Complete Pf?


Product Packages

NDC 0065-1509-28

Package Description: 1 BOTTLE, DROPPER in 1 CARTON > 10 mL in 1 BOTTLE, DROPPER

NDC 0065-1509-29

Package Description: 2 BOTTLE, DROPPER in 1 CARTON > 10 mL in 1 BOTTLE, DROPPER

Product Details

What are Systane Complete Pf Active Ingredients?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

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.
  • BORIC ACID (UNII: R57ZHV85D4)
  • DIMYRISTOYLPHOSPHATIDYLGLYCEROL, DL- (UNII: BI71WT9P3R)
  • GUARAPROLOSE (3500 MPA.S AT 1%) (UNII: 3A1I7376TC)
  • MINERAL OIL (UNII: T5L8T28FGP)
  • POLYOXYL 40 STEARATE (UNII: 13A4J4NH9I)
  • SORBITAN TRISTEARATE (UNII: 6LUM696811)
  • SORBITOL (UNII: 506T60A25R)
  • WATER (UNII: 059QF0KO0R)
  • HYDROCHLORIC ACID (UNII: QTT17582CB)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)

* Please review the disclaimer below.

Systane Complete Pf Labeling and Warnings

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



Otc - Active Ingredient



Active IngredientsPurpose
Propylene Glycol 0.6%Lubricant

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

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

Otc - 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

Otc - Keep Out Of Reach Of Children



Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.


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

Other Information



  • store at room temperature

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.


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.
    • 1Based on a survey of eye care professionals. Data on file.   
       *vs SYSTANE® BALANCE Lubricant Eye Drops


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

Nano-droplets for better coverage*

#1 DOCTOR RECOMMENDED BRAND1

Alcon

Sterile
10mL (0.34 FL OZ)

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.

Alcon Laboratories, Inc.
Fort Worth, TX 76134 USA
Country of United States
www.alconpatents.com

300048582-0521


* Please review the disclaimer below.