NDC 0078-0517 Genteal Mild

Hypromellose

NDC Product Code 0078-0517

NDC 0078-0517-16

Package Description: .025 L in 1 BOTTLE, DROPPER

NDC Product Information

Genteal Mild with NDC 0078-0517 is a a human over the counter drug product labeled by Novartis Pharmaceutical Corporation. The generic name of Genteal Mild is hypromellose. The product's dosage form is liquid and is administered via ophthalmic form.

Labeler Name: Novartis Pharmaceutical Corporation

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

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 Mild 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) 200 mg/L

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)
  • PHOSPHONIC ACID (UNII: 35V6A8JW8E)
  • POTASSIUM CHLORIDE (UNII: 660YQ98I10)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • SODIUM PERBORATE (UNII: Y52BK1W96C)
  • HYDROCHLORIC ACID (UNII: QTT17582CB)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)

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 Pharmaceutical 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.

Listing Expiration Date: 12-31-2020 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 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 Mild Product Label Images

Genteal Mild 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

Hypromellose (0.2%)

Otc - Purpose Section

Lubricant

Indications & Usage Section

  • Relieves dryness of the eye. Temporarily relieves discomfort due to minor irritations of the eye or from exposure to wind and sun. As a protectant against further irritation.

Warnings Section

For external use only.

Otc - Do Not Use Section

  • Do not useif solution changes color or becomes cloudy if you are sensitive to any ingredient in this product

Otc - When Using Section

When using this product do not touch tip of container to any surface. Replace cap after using.

Otc - Stop Use Section And Ask A Doctor

  • 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

Otc - Keep Out Of Reach Of Children Section

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

Dosage & Administration Section

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

Other Safety Information

Store between 15°-25°C (59°-77°F)

Inactive Ingredient Section

Boric acid, calcium chloride dihydrate, phosphonic acid, potassium chloride, purified water, sodium chloride and sodium perborate.  May contain hydrochloric acid and / or sodium hydroxide to adjust pH.

Otc - Questions Section

In the U.S., call toll-free 1-866-393-6336.MedInfo@AlconLabs.comSerious side effects associated with use of this product may be reported to this telephone number.www.genteal.com

* Please review the disclaimer below.