Genteal Tears Night-time
Mineral Oil, White Petrolatum
Alcon Laboratories, Inc.
Human Otc Drug
NDC 0065-0518Genteal Tears Night-time also known as Mineral Oil, White Petrolatum is a human otc drug labeled by 'Alcon Laboratories, Inc.'. National Drug Code (NDC) number for Genteal Tears Night-time is 0065-0518. This drug is available in dosage form of Ointment. The names of the active, medicinal ingredients in Genteal Tears Night-time drug includes Mineral Oil - .03 g/g Petrolatum - .94 g/g . The currest status of Genteal Tears Night-time drug is Active.
Drug Information:
| Drug NDC: | 0065-0518 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Genteal Tears Night-time |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Proprietary Name Base: | Genteal |
| The base of the Brand/Proprietary name excluding its suffix. |
| Proprietary Name Suffix: | Tears NIGHT-TIME |
| A suffix to the proprietary name, a value here should be appended to the ProprietaryName field to obtain the complete name of the product. This suffix is often used to distinguish characteristics of a product such as extended release (“XR”) or sleep aid (“PM”). Although many companies follow certain naming conventions for suffices, there is no recognized standard. |
| Product Type: | Human Otc Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Mineral Oil, White Petrolatum |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Alcon Laboratories, Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Ointment |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | MINERAL OIL - .03 g/g
PETROLATUM - .94 g/g
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | OPHTHALMIC
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | OTC MONOGRAPH FINAL |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (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. |
| Marketing Start Date: | 05 Sep, 2019 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 19 Dec, 2025 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Application Number: | part349 |
| 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. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | Alcon Laboratories, Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 706820
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UNII: | T5L8T28FGP
4T6H12BN9U
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 0065-0518-01 | 1 TUBE in 1 CARTON (0065-0518-01) / 3.5 g in 1 TUBE | 05 Sep, 2019 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Purpose:
Active ingredients purpose mineral oil 3 % lubricant white petrolatum 94 % lubricant
Product Elements:
Genteal tears night-time mineral oil, white petrolatum mineral oil mineral oil petrolatum petrolatum lanolin carton
Indications and Usage:
Uses for use as a lubricant to prevent further irritation to relieve dryness of the eye.
Warnings:
Warnings for external use only
Do Not Use:
Warnings for external use only
When Using:
When using this product do not touch tip of container to any surface replace cap after using
Dosage and Administration:
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.
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
Package Label Principal Display Panel:
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.
Further Questions:
Questions? in the u.s., call toll-free 1-800-757-9195 (mon-fri 9am-5pm cst) alcon.medinfo@alcon.com