NDC 71776-001 Freshkote Preservative Free Lubricant Eye Drops

Povidone, Polyvinyl Alcohol

NDC Product Code 71776-001

NDC Code: 71776-001

Proprietary Name: Freshkote Preservative Free Lubricant Eye Drops 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.

Non-Proprietary Name: Povidone, Polyvinyl Alcohol 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.


Code Structure
  • 71776 - Eyevance Pharmaceuticals
    • 71776-001 - Freshkote Preservative Free Lubricant Eye Drops

NDC 71776-001-10

Package Description: 1 BOTTLE, DROPPER in 1 BOX > 10 mL in 1 BOTTLE, DROPPER

NDC Product Information

Freshkote Preservative Free Lubricant Eye Drops with NDC 71776-001 is a a human over the counter drug product labeled by Eyevance Pharmaceuticals. The generic name of Freshkote Preservative Free Lubricant Eye Drops is povidone, polyvinyl alcohol. The product's dosage form is solution and is administered via ophthalmic form.

Labeler Name: Eyevance Pharmaceuticals

Dosage Form: Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.

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.


Freshkote Preservative Free Lubricant Eye Drops 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.

  • POVIDONE 20 g/1000mL
  • POLYVINYL ALCOHOL, UNSPECIFIED 27 g/1000mL

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)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • ALCOHOL (UNII: 3K9958V90M)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • POTASSIUM CHLORIDE (UNII: 660YQ98I10)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • WATER (UNII: 059QF0KO0R)

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.

Labeler Name: Eyevance Pharmaceuticals
Labeler Code: 71776
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: 03-13-2019 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.

Freshkote Preservative Free Lubricant Eye Drops Product Label Images

Freshkote Preservative Free Lubricant Eye Drops 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

Active Ingredients            PurposePolyvinyl Alcohol 2.7%.........LubricantPovidone 2.0%....................Lubricant

Indications & Usage

  • UsesFor use as a lubricant to reduce further irritation or to relieve dryness of the eye

Warnings

WarningsFor external use only.

Otc - Do Not Use

  • Do not use ifSeal is damagedSolution changes color or becomes cloudyYou are sensitive to any ingredient in this product

Otc - Stop Use

  • Stop use and ask a doctor ifYou experience eye painYou experience changes in visionYou experience continued redness or irritationCondition worsensSymptoms last more than 72 hours

Otc - Keep Out Of Reach Of Children

Keep out of reach of childrenIf swallowed, get medical help or contact a Poison Control Center right away.

Dosage & Administration

DirectionsInstill 1 or 2 drop(s) in the affected eye(s) as needed

Storage And Handling

  • Other informationUse before expiration date marked on containerStore at 20-25
  • ΟC(68-77
  • ΟF)
  • Retain this carton for future referenceDo not freeze

Inactive Ingredient

Inactive ingredientsBoric acid, Edetate disodium, Ethanol, Glycerin, Phospholipids, Polysorbate 80, Potassium chloride, Purified water, Sodium chloride.  May contain hydrochloric acid and/or sodium hydroxide to adjust pH.

Otc - Purpose

PurposeFor the temporary relief of discomfort due to minor irritations of the eye or to exposure to wind or sun

Otc - When Using

  • When using this productDo not touch tip of container to any surface to avoid contaminationReplace cap after usingShake off remaining drop before replacing cap

* Please review the disclaimer below.

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