NDC 0023-4554 Refresh Celluvisc

Carboxymethylcellulose Sodium

NDC Product Code 0023-4554

NDC 0023-4554-05

Package Description: 5 VIAL, SINGLE-USE in 1 CARTON > .4 mL in 1 VIAL, SINGLE-USE

NDC 0023-4554-30

Package Description: 30 VIAL, SINGLE-USE in 1 CARTON > .4 mL in 1 VIAL, SINGLE-USE

NDC Product Information

Refresh Celluvisc with NDC 0023-4554 is a a human over the counter drug product labeled by Allergan, Inc.. The generic name of Refresh Celluvisc is carboxymethylcellulose sodium. The product's dosage form is gel and is administered via ophthalmic form.

Labeler Name: Allergan, Inc.

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.

Refresh Celluvisc 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.

  • CARBOXYMETHYLCELLULOSE SODIUM 10 mg/mL

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.

  • CALCIUM CHLORIDE (UNII: M4I0D6VV5M)
  • POTASSIUM CHLORIDE (UNII: 660YQ98I10)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • SODIUM LACTATE (UNII: TU7HW0W0QT)

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: Allergan, Inc.
Labeler Code: 0023
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: 10-04-1989 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: 12-31-2019 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.

Refresh Celluvisc 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

Active Ingredient

Carboxymethylcellulose sodium 1%

Purpose

Eye lubricant

Uses

  • For the temporary relief of burning, irritation, and discomfort due to dryness of the eye or exposure to wind or sun.May be used as a protectant against further irritation.

Warnings

  • For external use only.To avoid contamination, do not touch tip of container to any surface. Do not reuse. Once opened, discardDo not touch unit-dose tip to eye.If solution changes color or becomes cloudy, do not use.

Stop Use And Ask A Doctor If

You experience eye pain, changes in vision, continued redness or irritation of the eye, or if the condition 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

To open, TWIST AND PULL TAB TO REMOVE. Instill 1 or 2 drops in the affected eye(s) as needed and discard container.

Other Information

  • Use only if single-use container.REFRESH® CELLUVISC® may cause temporary blurring due to its viscosity.Store at 59°-86°F (15°-30°C). Use before expiration date marked on container.RETAIN THIS CARTON FOR FUTURE REFERENCE.

Inactive Ingredients

Calcium chloride; potassium chloride; purified water; sodium chloride; and sodium lactate.

* Please review the disclaimer below.