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| Product NDC Code | 70403-921 | ||||
|---|---|---|---|---|---|
| Drug Name | Artificial tears |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | OPHTHALMIC | ||||
| Dosage Form | SOLUTION/ DROPS | ||||
| RxCUI drug identifier | 1718952 | ||||
| Application Number | part349 | ||||
| Labeler Name | Aru Pharma 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 10 MG in 1 ml.
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 Boric Acid, Potassium Chloride, Sodium Chloride, Calcium Chloride Dihydrate, Magnesium Chloride, Sodium Chlorite, Sodium Hydroxide and Water for Injection
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 protectant against further irritation or to relieve dryness of the eye for the temporary relief of discomfort due to minor irritations of the eye, or to exposure to wind or sun
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.ARTIFICIAL TEARS Carboxymethylcellulose Sodium CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED CARBOXYMETHYLCELLULOSE BORIC ACID POTASSIUM CHLORIDE SODIUM CHLORIDE CALCIUM CHLORIDE MAGNESIUM CHLORIDE SODIUM CHLORITE SODIUM HYDROXIDE 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.Packaging Artfdrp
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
Compare to the active ingredient in Refresh Plus Eye drops Lubricant Eye Drops Refresh, Lubricate and Moisturizes Distributed by. ARU PHARMA INC. MOUNT VERNON, NY 10552 www.qpackrx.com
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 the reach of children. If accidentally swallowed, get medical help or contact a Poison Control Center immediately.
Storage and handling
Information about safe storage and handling of the drug product.Other information Tamper Evident. Do not use this product if neckband is missing or broken. RETAIN THIS CARTON FOR FUTURE REFERENCE Store at 15°-30°C (59°-86°F)
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 this product if solution changes color or becomes cloudy 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 this product • to avoid contamination, do not touch tip of container to any surface • replace cap after using. Keep container tightly closed. • remove contact lens before using Keep out of the reach of children. If accidentally swallowed, get medical help or contact a Poison Control Center immediately.
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