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| Product NDC Code | 42126-6310 | ||||
|---|---|---|---|---|---|
| Drug Name | Oasis tears lubricant eye |
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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 | ||||
| RxCUI drug identifier | 998232, 998236 |
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| Application Number | part349 | ||||
| Labeler Name | OASIS Medical, 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 Ingredients Glycerin (0.22%)
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 Instill 1 or 2 drops in the affected eye(s) as needed.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients EDTA, potassium sorbate, sodium chloride, sodium hyaluronate, sodium hydroxide, sodium phosphate dibasic, sodium phosphate monobasic, 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 the temporary relief of burning and irritation due to dryness of the eye For the temporary relief of discomfort due to minor irritations of the eye or to exposure to wind or sun For use as a protectant against further irritation or to relieve dryness of the eye
Purpose
Information about the drug product’s indications for use.Purpose lubricant Eye Drops
Spl product data elements
Usually a list of ingredients in a drug product.OASIS Tears Lubricant Eye Glycerin HYALURONATE SODIUM SODIUM CHLORIDE SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM POTASSIUM SORBATE EDETATE DISODIUM WATER SODIUM HYDROXIDE GLYCERIN GLYCERIN
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 - 10mL Bottle Carton Oasis TEARS ® LUBRICANT EYE DROPS VISCOADAPTIVE...RELIEF FOR DRY EYES 10mL/0.3 fl. oz. OASIS TEARS
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Drug Facts
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use If solution changes color or becomes cloudy If you are sensitive to any ingredient in this product
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.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions, or to report an adverse event call: (800) 631-7180 or (909) 305-5400 or log onto www.oasistears.com
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
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product To avoid contamination do not touch tip of container to any surface Replace cap after using
Storage and handling
Information about safe storage and handling of the drug product.Other information Protect from light and freezing Store at or below 77°F/25°C
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 Do not use If solution changes color or becomes cloudy If you are sensitive to any ingredient in this product When using this product To avoid contamination do not touch tip of container to any surface Replace cap after using 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