NDC 0065-0426 Genteal Tears (moderate)

Dextran 70, Glycerin, Hypromellose

NDC Product Code 0065-0426

NDC 0065-0426-36

Package Description: 1 BOTTLE, DROPPER in 1 CARTON > 15 mL in 1 BOTTLE, DROPPER

Price per Unit: $0.43972 per ML

NDC 0065-0426-37

Package Description: 2 BOTTLE, DROPPER in 1 CARTON > 15 mL in 1 BOTTLE, DROPPER

NDC Product Information

Genteal Tears (moderate) with NDC 0065-0426 is a a human over the counter drug product labeled by Alcon Laboratories, Inc.. The generic name of Genteal Tears (moderate) is dextran 70, glycerin, hypromellose. The product's dosage form is solution/ drops and is administered via ophthalmic form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 900138.

Dosage Form: Solution/ Drops - A solution which is usually administered in a drop-wise fashion.

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.

Genteal Tears (moderate) 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.

  • BORIC ACID (UNII: R57ZHV85D4)
  • CALCIUM CHLORIDE (UNII: M4I0D6VV5M)
  • GLYCINE (UNII: TE7660XO1C)
  • HYDROCHLORIC ACID (UNII: QTT17582CB)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
  • POLIDRONIUM CHLORIDE (UNII: 6716Z5YR3G)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • POTASSIUM CHLORIDE (UNII: 660YQ98I10)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • ZINC CHLORIDE (UNII: 86Q357L16B)

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.

Pharmacological Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • Allergens - [CS]
  • Cell-mediated Immunity - [PE] (Physiologic Effect)
  • Glycerol - [CS]
  • Increased Histamine Release - [PE] (Physiologic Effect)
  • Increased IgG Production - [PE] (Physiologic Effect)
  • Increased Intravascular Volume - [PE] (Physiologic Effect)
  • Non-Standardized Chemical Allergen - [EPC] (Established Pharmacologic Class)
  • Osmotic Activity - [MoA] (Mechanism of Action)
  • Plasma Volume Expander - [EPC] (Established Pharmacologic Class)

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: 03-01-2016 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".

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Genteal Tears (moderate) Product Label Images

Genteal Tears (moderate) 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 ingredientsPurposeDextran 70 0.1%LubricantGlycerin 0.2%LubricantHypromellose 0.3%Lubricant

Uses

  • Temporary relief of burning and irritation due to dryness of the eyeas a protectant against further irritationtemporary relief of discomfort due to minor irritations of the eye or to exposure to wind or sun

Warnings

For external use only

Do Not Use

  • If this solution 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

Otc - Stop Use

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

  • Put 1 or 2 drops in the affected eye(s) as needed

Other Information

  • Store at room temperature

Inactive Ingredients:

Boric acid, calcium chloride, glycine, hydrochloric acid and/or sodium hydroxide (to adjust pH), magnesium chloride, POLYQUAD* (polyquaternium-1) 0.001% preservative, polysorbate 80, potassium chloride, purified water, sodium chloride, zinc chloride.

Questions?

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

* Please review the disclaimer below.