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| Product NDC Code | 11822-0011 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Artificial tears |
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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 | 259195 | ||||||
| Application Number | part349 | ||||||
| Labeler Name | RITE AID CORPORATION | ||||||
| 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 (0.3%) Propylene glycol (1.0%)
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 benzalkonium chloride (0.01%), boric acid, edetate disodium, potassium chloride, purified water, sodium borate, sodium chloride. Hydrochloric acid and/or sodium hydroxide may be used to adjust pH.
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 ▪ temporary relief of burning and irritation due to dryness of the eye ▪ prevents further irritation
Purpose
Information about the drug product’s indications for use.Purpose Lubricant Lubricant
Spl product data elements
Usually a list of ingredients in a drug product.artificial tears lubricant eye drops GLYCERIN GLYCERIN PROPYLENE GLYCOL PROPYLENE GLYCOL BENZALKONIUM CHLORIDE BORIC ACID EDETATE DISODIUM POTASSIUM CHLORIDE WATER SODIUM BORATE SODIUM CHLORIDE HYDROCHLORIC ACID SODIUM HYDROXIDE
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 – 30 mL Carton ARTIFICIAL TEARS lubricant eye drops soothing relief for dryness and irritation STERILE 1 FL OZ (30 mL) carton
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 ▪ store at 15-25°C (59-77°F) ▪ keep tightly closed ▪ use before expiration date marked on the carton and bottle
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? Call: 1-866-767-8975 DISTRIBUTED BY: RITE AID, 30 HUNTER LANE, CAMP HILL, PA 17011 www.riteaid.com
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 When using this product ▪ do not touch tip of container to any surface to avoid contamination ▪ remove contact lenses before using ▪ replace cap after use Stop use and ask a doctor if ▪ you experience eye pain, changes in vision, continued redness or irritation of the eye ▪ condition worsens or persists for 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