NDC 0065-1502 Systane Day And Night Value Pack

Polyethylene Glycol 400, Propylene Glycol 0.3%

NDC Product Code 0065-1502

NDC CODE: 0065-1502

Proprietary Name: Systane Day And Night Value Pack 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.

Non-Proprietary Name: Polyethylene Glycol 400, Propylene Glycol 0.3% 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.

NDC Code Structure

  • 0065 - Alcon Laboratories, Inc.

NDC 0065-1502-10

Package Description: 1 KIT in 1 CARTON * 10 mL in 1 BOTTLE * 10 mL in 1 BOTTLE

NDC Product Information

Systane Day And Night Value Pack with NDC 0065-1502 is a a human over the counter drug product labeled by Alcon Laboratories, Inc.. The generic name of Systane Day And Night Value Pack is polyethylene glycol 400, propylene glycol 0.3%. The product's dosage form is kit and is administered via form.

Labeler Name: Alcon Laboratories, Inc.

Dosage Form: Kit - A packaged collection of related material.

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.

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)
  • POLIDRONIUM CHLORIDE (UNII: 6716Z5YR3G)
  • POTASSIUM CHLORIDE (UNII: 660YQ98I10)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • HYDROCHLORIC ACID (UNII: QTT17582CB)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
  • BORIC ACID (UNII: R57ZHV85D4)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • GUAR GUM (UNII: E89I1637KE)
  • POLIDRONIUM CHLORIDE (UNII: 6716Z5YR3G)
  • POTASSIUM CHLORIDE (UNII: 660YQ98I10)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • SORBITOL (UNII: 506T60A25R)
  • WATER (UNII: 059QF0KO0R)
  • HYDROCHLORIC ACID (UNII: QTT17582CB)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)

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: 10-24-2017 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 Day And Night Value Pack 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

Otc - Purpose

Active ingredientsPurposePolyethylene Glycol 400 0.4%LubricantPropylene Glycol 0.3%Lubricant

Active ingredientsPurposePolyethylene Glycol 400 0.4%LubricantPropylene Glycol 0.3%Lubricant

Uses

  • Temporary relief of burning and irritation due to dryness of the eyetemporarily relieves discomfort due to minor irritations of the eye or to exposure to wind or sun

  • Temporary relief of burning and irritation due to dryness of the eyetemporarily relieves discomfort due to minor irritations of the eye or to exposure to wind or sun

Warnings

For external use only

For external use only

Do Not Use

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

  • 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 contaminationreplace cap after each use

  • Do not touch tip of container to any surface to avoid contaminationreplace cap after each use

Otc - Stop Use

  • Stop use and ask a doctor if you experience any of the following: eye painchanges in visioncontinued redness or irritation of the eyecondition worsens or persists for more than 72 hours

  • Stop use and ask a doctor if you experience any of the following: eye painchanges in visioncontinued redness or irritation of the eyecondition 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.

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

Directions

  • Shake well before usingput 1 or 2 drops in the affected eye(s) as needed

  • Shake well before usingput 1 or 2 drops in the affected eye(s) as needed

Other Information

  • Store at room temperature

  • Store at room temperature

Inactive Ingredients

Aminomethylpropanol, boric acid, hydroxypropyl guar, POLYQUAD* (polyquaternium-1) 0.001% preservative, potassium chloride, purified water, sodium chloride, sorbitol. May contain hydrochloric acid and/or sodium hydroxide to adjust pH.

Aminomethylpropanol, boric acid, edetate disodium, hydroxypropyl guar, POLYQUAD* (polyquaternium-1) 0.001% preservative, potassium chloride, sodium chloride, sorbitol and purified water. May contain hydrochloric acid and/or sodium hydroxide to adjust pH.

Questions?

In the U.S. call toll free 1-800-757-9195 (Mon-Fri 9AM-5PM CST) www.systane.com alcon.medinfo@alcon.com

In the U.S. call toll free 1-800-757-9195 (Mon-Fri 9AM-5PM CST) www.systane.com alcon.medinfo@alcon.com

* Please review the disclaimer below.