NDC 0065-0518 Genteal Tears Night-time
Mineral Oil, White Petrolatum Ointment Ophthalmic

Product Information

What is NDC 0065-0518?

The NDC code 0065-0518 is assigned by the FDA to the product Genteal Tears Night-time which is a human over the counter drug product labeled by Alcon Laboratories, Inc.. The generic name of Genteal Tears Night-time is mineral oil, white petrolatum. The product's dosage form is ointment and is administered via ophthalmic form. The product is distributed in a single package with assigned NDC code 0065-0518-01 1 tube in 1 carton / 3.5 g in 1 tube. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information, RxNorm crosswalk and the complete product label.

NDC Product Code0065-0518
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.
Genteal Tears Night-time
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.
Mineral Oil, White Petrolatum
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 FormOintment - 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.
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.
09-05-2019
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.
12-31-2023
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 Genteal Tears Night-time?


Product Packages

NDC Code 0065-0518-01

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

Price per Unit: $2.57924 per GM

Product Details

What are Genteal Tears Night-time 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.
  • MINERAL OIL .03 g/g - A mixture of liquid hydrocarbons obtained from petroleum. It is used as laxative, lubricant, ointment base, and emollient.
  • PETROLATUM .94 g/g - A colloidal system of semisolid hydrocarbons obtained from PETROLEUM. It is used as an ointment base, topical protectant, and lubricant.

Genteal Tears Night-time Active Ingredients UNII Codes

NDC to RxNorm Crosswalk

What is RxNorm? RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
  • RxCUI: 706820 - mineral oil 3 % / petrolatum 94 % Ophthalmic Ointment
  • RxCUI: 706820 - mineral oil 0.03 MG/MG / petrolatum 0.94 MG/MG Ophthalmic Ointment
  • RxCUI: 706820 - mineral oil 3 % / petrolatum, white 94 % Ophthalmic Ointment

Genteal Tears Night-time Inactive Ingredients UNII Codes

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.

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Genteal Tears Night-time Product Label

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.

Product Label Table of Contents



Otc - Purpose



Active ingredientsPurpose
Mineral oil 3 %Lubricant
White petrolatum 94 %Lubricant

Uses



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

Warnings



For external use only


Do Not Use



  • if you are sensitive to any ingredient in this product

When Using This Product



  • do not touch tip of container to any surface
  • replace cap after using

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

Keep Out Of Reach Of Children



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


Directions



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:



Anhydrous liquid lanolin


Questions?



In the U.S., call toll-free 1-800-757-9195
(Mon-Fri 9AM-5PM CST)
[email protected]


Principal Display Panel



Severe
DRY EYE SYMPTOM RELIEF 


OINTMENT

GenTeal®
Tears

LUBRICANT EYE OINTMENT

GenTeal® Night-time PM ointment provides long-lasting relief for night-time comfort.

NIGHT-TIME OINTMENT
Long-lasting Night-time Relief

STERILE 3.5 g (0.12 FL OZ)

Alcon®

TAMPER EVIDENT:
For your protection, use only if cap and necking are intact at time of purchase.

Distributed by:
ALCON LABORATORIES, INC.,
6201 South Freeway
Fort Worth, Texas 76134 USA
Country of Origin: Belgium

787130-1218

LOT:
EXP.:

Please read this carton carefully and keep for future reference.


* Please review the disclaimer below.