NDC 0065-0509 Systane Nighttime

Mineral Oil And White Petrolatum

  1. Labeler Index
  2. Alcon Laboratories, Inc.
  3. NDC: 0065-0509 Systane Nighttime

NDC Product Code 0065-0509

NDC CODE: 0065-0509

Proprietary Name: Systane Nighttime 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: Mineral Oil And White Petrolatum 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 0065-0509-35

Package Description: 1 TUBE in 1 CARTON > 3.5 g in 1 TUBE

Price per Unit: $2.32926 per GM

NDC Product Information

Systane Nighttime with NDC 0065-0509 is a a human over the counter drug product labeled by Alcon Laboratories, Inc.. The generic name of Systane Nighttime is mineral oil and white petrolatum. The product's dosage form is ointment and is administered via ophthalmic form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 706820.

Dosage Form: Ointment - A semisolid3 dosage form, usually containing <20% water and volatiles5 and >50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.

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 Nighttime 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.

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.
  • LANOLIN (UNII: 7EV65EAW6H)

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.

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: 06-26-2008 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: 12-31-2022 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 - NO 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".

* Please review the disclaimer below.

Systane Nighttime Product Label Images

Systane Nighttime 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 - Active Ingredient Section

Mineral Oil 3%White Petrolatum 94%

Otc - Purpose Section

Lubricant

Indications & Usage Section

  • For use as a lubricant to prevent further irritation or to relieve dryness of the eye.

Warnings Section

For external use only

Otc - Do Not Use Section

  • If you are sensitive to any ingredient in this product

Otc - When Using Section

  • Remove contact lenses before using to avoid contamination, do not touch tip of container to any surface replace cap after using

Otc - Stop Use Section 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

Otc - Keep Out Of Reach Of Children Section

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

Dosage & Administration Section

Pull down the lower lid of the affected eye and apply a small amount (one-fourth inch) of ointment to the inside of the eyelid.

Other Information

  • Store at 8°-27°C (46°-80°F).

Inactive Ingredient Section

Anhydrous Liquid Lanolin 3%.

Otc - Questions Section

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

* Please review the disclaimer below.