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| Product NDC Code | 0023-4554 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Refresh celluvisc |
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| Type | Brand | ||||||
| Active Ingredients |
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| Route | OPHTHALMIC | ||||||
| Dosage Form | GEL | ||||||
| RxCUI drug identifier | 579907 | ||||||
| Application Number | M018 | ||||||
| Labeler Name | Allergan, Inc. | ||||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Carboxymethylcellulose sodium 1%
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.Directions To open, TWIST AND PULL TAB TO REMOVE . Instill 1 or 2 drops in the affected eye(s) as needed and discard container.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Calcium chloride dihydrate; potassium chloride; purified water; sodium chloride; and sodium lactate.
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.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.
Purpose
Information about the drug product’s indications for use.Purpose Eye lubricant
Spl product data elements
Usually a list of ingredients in a drug product.REFRESH CELLUVISC carboxymethylcellulose sodium CARBOXYMETHYLCELLULOSE SODIUM CARBOXYMETHYLCELLULOSE CALCIUM CHLORIDE POTASSIUM CHLORIDE WATER SODIUM CHLORIDE SODIUM LACTATE
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.PRINCIPAL DISPLAY PANEL NDC 0023-4554-30 Preservative-free Refresh ® Celluvisc ® Lubricant Eye Gel EXTRA-STRENGTH GEL Soothes & Comforts Dry, Irritated Eyes30 Single-Use Containers 0.01 fl oz (0.4 mL) each Sterile PRINCIPAL DISPLAY PANEL NDC 0023-4554-30 Preservative-free Refresh® Celluvisc® Lubricant Eye Gel EXTRA-STRENGTH GEL Soothes & Comforts Dry, Irritated Eyes30 Single-Use Containers 0.01 fl oz (0.4 mL) each Sterile
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information Use only if single-use container is intact. REFRESH ® CELLUVISC ® may cause temporary blurring due to its viscosity. Store at 59°-77°F (15°-25°C). Use before expiration date marked on container. RETAIN THIS CARTON FOR FUTURE REFERENCE.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or comments? 1.800. 678 .1 605 refreshbrand.com v1.0DFL4554
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.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.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.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 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.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API