NDC 0023-4491 Refresh Optive Advanced

Carboxymethylcellulose Sodium, Glycerin, Polysorbate 80

NDC Product Code 0023-4491

NDC CODE: 0023-4491

Proprietary Name: Refresh Optive Advanced 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: Carboxymethylcellulose Sodium, Glycerin, Polysorbate 80 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.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • This medication is used to relieve dry, irritated eyes. Common causes for dry eyes include wind, sun, heating/air conditioning, computer use/reading, and certain medications. This product may contain 1 or more of the following ingredients: carboxymethylcellulose, dextran, glycerin, hypromellose, polyethylene glycol 400 (PEG 400), polysorbate, polyvinyl alcohol, povidone, or propylene glycol, among others. Eye lubricants keep the eye moist, help to protect the eye from injury and infection, and decrease symptoms of dry eyes such as burning, itching, and feeling as if something is in the eye.
  • This product is used to relieve occasional constipation. Glycerin belongs to a class of drugs known as hyperosmotic laxatives. It works by drawing water into the intestines. This effect usually results in a bowel movement within 15 to 60 minutes. For adults, the normal frequency of bowel movements varies from once daily to 1 to 2 times weekly. For preschool-aged children, the normal frequency of bowel movements varies from once daily to once every other day. Constipation is best treated by drinking plenty of fluids, eating foods high in fiber, and exercising regularly.

NDC Code Structure

NDC 0023-4491-05

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

NDC 0023-4491-30

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

NDC Product Information

Refresh Optive Advanced with NDC 0023-4491 is a a human over the counter drug product labeled by Allergan, Inc.. The generic name of Refresh Optive Advanced is carboxymethylcellulose sodium, glycerin, polysorbate 80. The product's dosage form is solution/ drops and is administered via ophthalmic form.

Labeler Name: Allergan, Inc.

Dosage Form: Solution/ Drops - A solution which is usually administered in a drop-wise fashion.

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 Optive Advanced 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 5 mg/mL
  • GLYCERIN 10 mg/mL
  • POLYSORBATE 80 5 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.

  • BORIC ACID (UNII: R57ZHV85D4)
  • CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)
  • CASTOR OIL (UNII: D5340Y2I9G)
  • ERYTHRITOL (UNII: RA96B954X6)
  • LEVOCARNITINE (UNII: 0G389FZZ9M)
  • WATER (UNII: 059QF0KO0R)
  • 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: 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: 01-15-2013 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: 12-31-2021 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 Optive Advanced Product Label Images

Refresh Optive Advanced 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 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.

Otc - Stop 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.

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

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 59º-86ºF (15º-30ºC).
  • RETAIN THIS CARTON FOR FUTURE REFERENCE.

Inactive Ingredients

Boric acid; carbomer copolymer type A; castor oil; erythritol; levocarnitine; purified water; and sodium hydroxide.

* Please review the disclaimer below.