NDC 0023-5773 Refresh Optive Mega-3
Carboxymethylcellulose Sodium, Glycerin And Polysorbate 80 Solution/ Drops Ophthalmic

Product Information

Refresh Optive Mega-3 is a human over the counter drug product labeled by Allergan, Inc.. The generic name of Refresh Optive Mega-3 is carboxymethylcellulose sodium, glycerin and polysorbate 80. The product's dosage form is solution/ drops and is administered via ophthalmic form.

Product Code0023-5773
Proprietary Name 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.
Refresh Optive Mega-3
Non-Proprietary Name 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.
Carboxymethylcellulose Sodium, Glycerin And Polysorbate 80
Product Type 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.
Human Otc Drug
Dosage FormSolution/ Drops - A solution which is usually administered in a drop-wise fashion.
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.
Allergan, Inc.
Labeler Code0023
FDA Application Number 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.
part349
Marketing Category 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.
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
05-30-2017
Listing Expiration Date 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.
12-31-2023
Exclude Flag 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".
N
NDC Code Structure

What are the uses for Refresh Optive Mega-3?


Product Packages

NDC 0023-5773-05

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

NDC 0023-5773-30

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

Price per Unit: $0.42146 per EA

Product Details

What are Refresh Optive Mega-3 Active Ingredients?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

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)
  • BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
  • CASTOR OIL (UNII: D5340Y2I9G)
  • ERYTHRITOL (UNII: RA96B954X6)
  • LEVOCARNITINE (UNII: 0G389FZZ9M)
  • CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)
  • POLYOXYL 40 STEARATE (UNII: 13A4J4NH9I)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • TREHALOSE (UNII: B8WCK70T7I)

Pharmacologic Class(es)

A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

* Please review the disclaimer below.

Refresh Optive Mega-3 Labeling and Warnings

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



Active Ingredients



Carboxymethylcellulose sodium 0.5%
Glycerin 1%
Polysorbate 80 0.5%


Purpose



Eye lubricant
Eye lubricant
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, discard.
  • Do not touch unit-dose tip to eye.
  • If solution changes color, 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 is intact.   
  • Use before expiration date marked on container.
  • Store at 59°-86°F (15°-30°C).
  • Store vials in pouch until use.
  • RETAIN THIS CARTON FOR FUTURE REFERENCE.

Inactive Ingredients



Boric acid; butylated hydroxyl toluene; castor oil; erythritol; flaxseed oil; levocarnitine; pemulen TR-2; polyoxyl 40 stearate; purified water; sodium hydroxide; trehalose.


Questions Or Comments?



1.800.678.1605

refreshbrand.com

© 2017 Allergan. All rights reserved.

All trademarks are the property of their respective owners.           


Principal Display Panel



NDC 0023-5773-30

Preservative-free
Refresh
Optive® 
MEGA-3
Lubricant Eye Drops

ENHANCED WITH FLAXSEED OIL

Prevents tear evaporation and restores all

three layers of the tear film damaged by Dry Eye.
30 Single-Use Containers
0.01 fl oz (0.4 mL) each Sterile


* Please review the disclaimer below.