NDC 0078-0429 Genteal Severe

Hypromellose

NDC Product Code 0078-0429

NDC 0078-0429-47

Package Description: 1 TUBE in 1 CARTON > 10 g in 1 TUBE

NDC Product Information

Genteal Severe with NDC 0078-0429 is a a human over the counter drug product labeled by Novartis Pharmaceuticals Corporation. The generic name of Genteal Severe is hypromellose. The product's dosage form is gel and is administered via ophthalmic form.

Labeler Name: Novartis Pharmaceuticals Corporation

Dosage Form: Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.

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 Severe 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.

  • HYPROMELLOSE 2910 (4000 MPA.S) .003 g/g

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.

  • SODIUM PERBORATE (UNII: Y52BK1W96C)
  • PHOSPHORIC ACID (UNII: E4GA8884NN)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • SORBITOL (UNII: 506T60A25R)

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.
  • 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: Novartis Pharmaceuticals Corporation
Labeler Code: 0078
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: 09-14-2009 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

End Marketing Date: 08-31-2021 What is the End Marketing Date?
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.

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.

Genteal Severe Product Label Images

Genteal Severe 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 ingredientPurposeHypromellose 0.3%. Lubricant

Uses

  • Relieves dryness of the eye.temporarily relieves discomfort due to minor irritations of the eye or to exposure to wind or sun.as a protectant against further irritation.

Warnings

For external use only

Do Not Use

  • If gel 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 surfacereplace cap after using

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

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.

Directions

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

Other Information

  • Store between 15º - 25ºC (59º - 77ºF)

Inactive Ingredients

Carbopol 980, phosphoric acid, purifed water, sodium hydroxide, sodium perborate, and sorbitol

Questions?

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

* Please review the disclaimer below.