Methods: This retrospective study comprised 105 patients (210 eyes) who had primary bilateral LASIK by 1 of 2 surgeons between … Setting: Community-based refractive center. View NDC Code(s)NEW! The medication in REFRESH CELLUVISC can be sold under different names. For further information about unapproved drugs, click here. DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. The generic name of Refresh Tears is carboxymethylcellulose sodium. The product labeling information includes all published material associated to a drug. Cautions. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Carboxymethylcellulose Sodium; Approved Uses * No other uses available * Extracted from Drug Label . Eye lubricant. 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. The product's dosage form is solution/ drops and is administered via ophthalmic form. Brands and Other Names. this version. Refresh Plus with NDC 0023-0403 is a a human over the counter drug product labeled by Allergan, Inc.. Refresh Plus is preservative-free for sensitive eyes, and can be used as often as needed to provide 24-hour comfort. Preparation. The average cost for 1 Plas Cont, 30 solution each, is $15.49. For external use only.To avoid contamination, do not touch tip of container to any surface. Active ingredient. Fact. Proprietary Name: Refresh Plus 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. NDC Code (s): 50268-067-30, 50268-067-50, 50268-067-70. Uses. For the temporary relief of burning, irritation, and discomfort due to dryness of the eye or exposure to wind or sun. Refresh Tears with NDC 0023-0798 is a a human over the counter drug product labeled by Allergan, Inc.. Following the initial reaction, the resultant mixture produces about 60% CMC plus 40% salts (sodium chloride and sodium glycolate).This product is the so-called technical CMC which is used in detergents. Citations. If you are a consumer or patient please visit Many of Over the Counter drugs are not reviewed by the FDA but they might be marketed to the public if the product complies with the applicable rules and regulations. For unapproved drugs, this field will be null. REFRESH PLUS- carboxymethylcellulose sodium solution/ drops If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such. May be used as a protectant against further irritation. Use only if single-use container is intact.Use before expiration date marked on container.Store at 59°-86°F (15°-30°C). Pharmacology, adverse reactions, warnings and side effects. Discontinue and contact physician if pain, changes in vision, continued redness or irritation of the eye, or if the condition worsens or persists for >72 hr For further information about unapproved drugs, click here. Report Adverse Hypersensitivity to ingredients. May also contain hydrochloric acid and/or sodium hydroxide to adjust pH. Events, (What https://dailymed.nlm.nih.gov/dailymed/labelrss.cfm?setid=b478a695-ded0-2e5f-e053-2995a90ac45e, https://dailymed.nlm.nih.gov/dailymed/rss.cfm. 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. Popular Brands: : Refresh Plus, Refresh Tears, Carmellose, Theratears, Carboxymethylcellulose Sodium Official FDA Reports 3,462. Refresh Plus Eye Drops does more than just soothe and relieve dry and irritated eyes. 1 to 2 drops carboxymethylcellulose sodium based (REFRESH PLUS®) eye drops in each eye as per protocol for 90 days. TWIST AND PULL TAB TO REMOVE. Start Marketing Date: 10-09-1996 What is the Start Marketing Date?This is the date that the labeler indicates was the start of its marketing of the drug product. Currently, only final marketed product categories are included. This is a brand name drug and a generic may be available. Social Media Events 0. Garboxymethylcellulose sodium increases tear viscosity and has pseudoelastic (i.e. Labeler Name: Allergan, Inc. •Other ingredients are calcium chloride, magnesium chloride, potassium chloride, sodium chloride, purified water with boric acid and sodium borate (as buffers). Presence in Breast Milk, Medline Plus, Carboxymethylcellulose sodium 0.5%. All contents of this website are provided on an "as is" and "as available" basis without warranty of any kind. Primary Outcome Measures : Cornea Staining Score [ Time Frame: 8 weeks ] Secondary Outcome Measures … Xi'an Bpanda Biological Technology Co., Ltd. If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222). Calcium chloride; magnesium chloride; potassium chloride; purified water; sodium chloride; and sodium lactate. Check out Lubricating Plus Eye Drops Carboxymethylcellulose Sodium 0.5% Generic for Refresh Plus 70 Sterile 0.01 fl oz (0.4 ml) Single Use Containers reviews, ratings, specifications … Artificial tears comprising sodium hyaluronate and carboxymethylcellulose Download PDF Info Publication number WO2014121232A1 . The medication in Refresh Optive can be sold under different names. US $2.00-$2.80 / Kilogram . Label: REFRESH PLUS- carboxymethylcellulose sodium solution/ drops. 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. Common causes for dry eyes include wind, sun, heating/air conditioning, computer use/reading, and certain medications. The information in this website is intended for healthcare providers and consumers in the United States. Active Ingredients. DISCLAIMER: Refresh Plus; Refresh Tears; Carmellose; … Carboxymethylcellulose sodium is based on its physical properties which provides a lubricant effect and prolonged residence time on the eye. Drug: carboxymethylcellulose sodium based eye drops 1 to 2 drops carboxymethylcellulose sodium based (REFRESH PLUS®) eye drops in each eye as per protocol for 90 days. Once opened, discard.Do not touch unit-dose tip to eye.If solution changes color or becomes cloudy, do not use. DailyMed will deliver this notification to your desktop, Web browser, or e-mail depending on the RSS Reader you select to use. Get an overview of REFRESH OPTIVE (carboxymethylcellulose sodium, glycerin solution/ drops), including its generic name, formulation (i.e. Sublimation Paper Coating Chemicals CMC Sodium Carboxymethyl Cellulose with high resistence. Clinical Trials, is this? 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. Get Label RSS Feed, Files, All Mapping 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. Files, Presentations Do not. 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. 50268-067-70, To avoid contamination, do not touch tip of container to any surface. Values = ‘Y’ or ‘N’. This data element matches the “Document Type” field of the Structured Product Listing. 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. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc. To open, The product's dosage form is solution/ drops and is administered via ophthalmic form. Also recommended for LASIK dryness*30 Single-Use Containers0.01 fl oz (0.4 mL) each Sterile - refresh plus 02. Labeler Name: Allergan, Inc. 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. DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. Go to Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information. DailyMed will deliver notification of updates and additions to Drug Label information currently shown on this site through its RSS feed. Ophthalmic - Administration to the external eye. For topical ophthalmic use only. PDR Drug Summaries are concise point-of-care prescribing, dosing and administering information to help phsyicans more efficiently and accurately prescribe in their practice PDR's drug summaries are available free of charge and serve as a great resource for US based MDs, DOs, NPs and PAs in … Do not reuse. Demonstrated to improve dry eye when used after Lasik. PDR Drug Summaries are concise point-of-care prescribing, dosing and administering information to help phsyicans more efficiently and accurately prescribe in their practice PDR's drug summaries are available free of charge and serve as a great resource for US based MDs, DOs, NPs and PAs in … Review Score 0.00 / 5. Calcium chloride; hydrochloric acid; magnesium chloride; potassium chloride; purified water; sodium chloride; sodium hydroxide and sodium lactate. If swallowed, get medical help or contact a Poison Control Center right away. We anticipate reposting the images once we are able identify and filter out images that do not match the information provided in the drug labels. Purpose. 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. The polar (organic acid) carboxyl groups render the cellulose soluble and chemically reactive.. This medication is used to relieve dry, irritated eyes. For further information about unapproved drugs, click here. Marketing Category: OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. Reliance on any information provided by the National Drug Codes List website or other visitors to this website is solely at your own risk. REFRESH PLUS ® is also recommended for sensitive eyes and can be used after LASIK or other eye surgeries. Make your dry eyes feel better with the drops doctors recommend. Amazon.in: Buy Lubricating Plus Eye Drops Carboxymethylcellulose Sodium 0.5% Generic for Refresh Plus 70 Sterile 0.01 fl oz (0.4 ml) Single Use Containers online at low price in India on Amazon.in. For the temporary relief of burning, irritation, and discomfort due to dryness of the eye or exposure to wind or sun. REFRESH PLUS® has also been demonstrated to relieve post-LASIK dryness. Total Posts 0. Refresh Plus with NDC 0023-0403 is a a human over the counter drug product labeled by Allergan, Inc.. *If used for post-operative (e.g., LASIK) dryness and discomfort, follow your eye doctor’s instructions. PRINCIPAL DISPLAY PANELNDC 0023-0403-30Preservative-freeRefreshPlusLubricant Eye DropsMOISTURIZING RELIEF Immediate, soothing relief for dry eyes. Carboxymethylcellulose Sodium (0.5%) Eye Lubricant For the temporary relief of burning, irritation, and discomfort due to dryness of the eye or exposure to wind or sun. Events, The product's dosage form is solution/ drops and is administered via ophthalmic form. COVID-19 is an emerging, rapidly evolving situation. (current), carboxymethylcellulose sodium 0.5 % Ophthalmic Solution, carboxymethylcellulose sodium 5 MG/ML Ophthalmic Solution, carboxymethylcellulose sodium 0.5 GM per 100 ML Ophthalmic Solution. Carboxymethylcellulose sodium | C8H16NaO8 | CID 6328154 - structure, chemical names, physical and chemical properties, classification, patents, literature, biological activities, safety/hazards/toxicity information, supplier lists, and more. To view updated drug label links, paste the RSS feed address (URL) shown below into a RSS reader, or use a browser which supports RSS feeds, such as Safari for Mac OS X. Dosage Form: Solution/ Drops - A solution which is usually administered in a drop-wise fashion. PubMed, Get the latest public health information from CDC: https://www.coronavirus.gov. May also contain hydrochloric acid and/or sodium hydroxide to adjust pH. 50268-067-50, Updated ), More about getting RSS News & Updates from DailyMed, 0.4 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product, 1 1 Kilogram (Min. Avg. It comes in preservative-free single-use vials and has many of the same healthy qualities as your own natural tears. Seven Tips for Managing Healthcare Teamwork During a Pandemic; Physician Overlooks MRI, Then Claims Chiropractor Patient Should Have Read It; Boosting Income During the COVID-19 Crisis If you have questions or concerns about the substances you are taking, check with your healthcare provider. RxNorm, Refresh Plus Lubricant Eye Drops instantly moisturizes and relieves dry, irritated eyes with a fast-acting, long-lasting formula for sensitive eyes that has many of the same healthy qualities as your own natural tears. FDA Safety Recalls, Non-Proprietary Name: Carboxymethylcellulose Sodium What is the Non-Proprietary Name?The non-proprietary name is sometimes called the generic name. If you think you may have a medical emergency, please call your doctor or 911 immediately. It is synthesized by the alkali-catalyzed reaction of cellulose with chloroacetic acid. 1 Kilogram (Min. Biochemical Data Summary. The generic name of Refresh Plus is carboxymethylcellulose sodium. FDA has not evaluated whether this product complies.-----REFRESH PLUS ® Lubricant Eye Drops carboxymethylcellulose sodium solution/ drops, All Drug Vanimate Industries Co., Ltd. If you no longer wish to have this DailyMed RSS service, simply delete the copied URL from your RSS Reader. Labels, All Index US $3.00-$7.00 / Kilogram . Purpose: To investigate the effect of the addition of electrolytes, basic tear solution (BTS), and sodium carboxymethylcellulose (SCMS) on the tear ferning (TF) patterns of Blink Contact Soothing Eye Drops ® and Refresh Plus Tears ®. Purpose: To evaluate the incidence of epithelial defects that occur with laser in situ keratomileusis (LASIK) using nonpreserved carboxymethylcellulose sodium 0.5% solution (Refresh Plus(R)) intraoperatively. The generic name usually includes the active ingredient(s) of the product. Instill 1 or 2 drops in the affected eye(s) as needed and discard container. Outcome Measures. Samples of Blink Contact Soothing Eye Drops ® and Refresh Plus Tears ® (10 μL) were mixed with different volumes (3–30 μL) of several electrolytes, namely sodium chloride, potassium chloride, calcium chloride, magnesium chloride hexahydrate, sodium hydrogen carbonate, and sodium dihydrogen phosphate, BTS, and SCMS. Major Lubricating Plus Dry Eye Drops CARBOXYMETHYLCELLULOSE Sodium-1% Clear 50X0.4 ML UPC 309046329510 4.7 out of 5 stars 3 $17.99 Refresh Plus Lubricant Eye Drops, Single-Use Containers, (50 Count of 0.01 Fl Oz Containers), 0.5 Fl Oz REFRESH PLUS® instantly moisturizes to provide immediate, soothing relief for dry, irritated eyes. Other Name: REFRESH PLUS® Outcome Measures. View Labeling Archives, Wholesale High Quality Hydroxyethyl cellulose with low price. Contraindications. Follow your eye doctor's instructions if you are using REFRESH PLUS ® after an eye surgery (e.g., LASIK) to relieve dryness and discomfort. November 19, 2020. The absence of a warning or notice for a given drug or drug combination is not indication that the drug or drug combination are safe, appropriate or effective for any given patient. 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