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| Product NDC Code | 72972-005 | ||||
|---|---|---|---|---|---|
| Drug Name | Optase |
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| 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] |
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| Active Ingredients |
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| Route | OPHTHALMIC | ||||
| Dosage Form | SOLUTION/ DROPS | ||||
| Application Number | M018 | ||||
| Labeler Name | Scope Health 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.0.25 % glycerin
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: Put one or two drops in the affected eyes as needed.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients: Borax, Boric Acid, Citric Acid anhydrous, Sodium Chloride, Sodium Citrate Dihydrate, Sodium Hyaluronate, 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.Uses • 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 SODIUM BORATE SODIUM CHLORIDE BORIC ACID ANHYDROUS CITRIC ACID GLYCERIN GLYCERIN HYALURONATE SODIUM TRISODIUM CITRATE DIHYDRATE WATER
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 Hylo Relief
Immediate label Optase Hylo Relief
Instructions for use
Information about safe handling and use of the drug product.Patient Information Leaflet- Page 1 Instructions for use
Patient Information Leaflet- Page 2 Instructions for use
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.
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. • If solution changes color or becomes cloudy, do not use. Stop use and ask doctor if • You feel eye pain. • Changes in vision occur. • Redness or irritation of the eye lasts. • Condition worsens or lasts more than 72 hours
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