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Optase - Medication Information

Product NDC Code 72972-007
Drug Name

Optase

Type Brand
Pharm Class Allergens [CS],
Cell-mediated Immunity [PE],
Glycerol [CS],
Increased Histamine Release [PE],
Increased IgG Production [PE],
Non-Standardized Chemical Allergen [EPC]
Active Ingredients
Glycerin 2 mg/ml
Route OPHTHALMIC
Dosage Form SOLUTION/ DROPS
RxCUI drug identifier 998232
Application Number M018
Labeler Name Scope Health Inc
Packages
Package NDC Code Description
72972-007-05 1 dose pack in 1 box (72972-007-05) / 5 bottle, unit-dose in 1 dose pack / .5 ml in 1 bottle, unit-dose
72972-007-30 1 dose pack in 1 box (72972-007-30) / 30 bottle, unit-dose in 1 dose pack / .5 ml in 1 bottle, unit-dose
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Glycerin 0.2%

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.
• Please wash your hands before use. • Open the aluminium pouch and pull out the strip of single-dose containers. • Remove one of the single-dose containers from the strip. • Place the remaining single-dose containers back and close the pouch by folding the edge over. • To open, twist and pull tab to remove. • Do not touch the tip after opening the container. • Put one or two drops in the affected eyes as needed • Use immediately once opened. • Do not reuse. • Discard any remaining solution after use. • No ingredients of animal origin. • Contact lens compatible.

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients Hydrochloric Acid, Sodium Hyaluronate, Sorbitol, Trometamol, Water

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.
• For use as a lubricant to prevent further irritation. • May be used as a protectant against further irritation. •To relieve dryness of the eye.

Purpose

Information about the drug product’s indications for use.
Eye Lubricant

Spl product data elements

Usually a list of ingredients in a drug product.
Optase glycerin GLYCERIN GLYCERIN HYALURONATE SODIUM HYDROCHLORIC ACID WATER TROMETHAMINE SORBITOL

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.
Optase Intense - 30 Patient Information Leaflet- 30 count Patient Leaflet Patient Information Leaflet- IFU Patient Leaflet Optase Intense 5 Patient Information Leaflet- 5 count Patient Leaflet Patient Leaflet - IFU - 5 count Patient Leaflet Single Dose Aluminum Foil Label- 5 pack Optase Intense Single Dose Aluminum Foil Label- 5 pack Optase Intense

Instructions for use

Information about safe handling and use of the drug product.
Patient Information Leaflet- IFU Patient Leaflet Patient Leaflet - IFU - 5 count Patient Leaflet

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.

General precautions

Information about any special care to be exercised for safe and effective use of the drug.
Patient Information Leaflet- 30 count Patient Leaflet

Precautions

Information about any special care to be exercised for safe and effective use of the drug.
Patient Information Leaflet- 5 count Patient Leaflet

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.
Warning • For external use only. • To avoid contamination, do not touch tip of container to any surface. • If solution changes color or becomes cloudy, do not use. • Do not use a damaged or punctured single-dose container. • Wait at least 15 minutes between possible applications of other ophthalmic medication. • Use immediately once opened. • Do not reuse. Discard any remaining solution after use. • Do not use if you are sensitive to any of the ingredients. • Do not use after the expiry date shown on the pack.

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