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Artificial tears - Medication Information

Product NDC Code 11822-0011
Drug Name

Artificial tears

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 3 mg/ml
Propylene glycol 10 mg/ml
Route OPHTHALMIC
Dosage Form SOLUTION/ DROPS
RxCUI drug identifier 259195
Application Number M018
Labeler Name RITE AID CORPORATION
Packages
Package NDC Code Description
11822-0011-3 1 bottle in 1 carton (11822-0011-3) / 30 ml in 1 bottle
11822-0011-5 1 bottle in 1 carton (11822-0011-5) / 15 ml in 1 bottle
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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 BENZALKONIUM CHLORIDE BORIC ACID EDETATE DISODIUM POTASSIUM CHLORIDE WATER SODIUM BORATE SODIUM CHLORIDE HYDROCHLORIC ACID SODIUM HYDROXIDE GLYCERIN GLYCERIN PROPYLENE GLYCOL PROPYLENE GLYCOL

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) RiteAid 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