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Artificial tears - Medication Information

Product NDC Code 70403-920
Drug Name

Artificial tears

Type Brand
Active Ingredients
Polyvinyl alcohol, unspecified 14 mg/ml
Route OPHTHALMIC
Dosage Form SOLUTION/ DROPS
RxCUI drug identifier 142004
Application Number part349
Labeler Name Aru Pharma Inc.
Packages
Package NDC Code Description
70403-920-15 1 bottle, dropper in 1 carton (70403-920-15) / 15 ml in 1 bottle, dropper
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active Ingredient Polyvinyl Alcohol 1.4%

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, dibasic sodium phosphate hydrate, edetate disodium hydrate, monobasic sodium phosphate dihydrate, purified water, sodium chloride

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 relieves dryness of the eye prevents further irritation

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 Polyvinyl Alcohol POLYVINYL ALCOHOL, UNSPECIFIED POLYVINYL ALCOHOL, UNSPECIFIED BENZALKONIUM CHLORIDE SODIUM PHOSPHATE, DIBASIC, DODECAHYDRATE EDETATE DISODIUM SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE WATER SODIUM CHLORIDE

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 Qpack1

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 Liquifilm Tears Eye Drops Lubricant Eye Drops Prevents Irritation and Relieves Dryness of the eye Distributed by. ARU PARMA 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 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.
Question or comments? 1-844-500-2729 between 9 am and 4 pm EST, Monday-Friday.

Storage and handling

Information about safe storage and handling of the drug product.
Other information store at 15°-25°C (59°-77°F) keep tightly closed

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 Do not use if solution changes colour or becomes cloudy with contact lenses When using this product do not touch tip of container to any surface to avoid contamination replace cap after each 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 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