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Product NDC Code | 64108-313 | ||||||||||
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Drug Name | Ocufresh |
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Type | Brand | ||||||||||
Active Ingredients |
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Route | OPHTHALMIC | ||||||||||
Dosage Form | LIQUID | ||||||||||
RxCUI drug identifier | 1489376, 1489378 |
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Application Number | M018 | ||||||||||
Labeler Name | Optics Laboratory Inc. | ||||||||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Drug Facts Active Ingredient (in each ml) PURIFIED WATER 98.8%
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: do not dilute solution or reuse bottle hold container a few inches above the eye control rate of flow by pressure on bottle flush affected area as needed Without Cup hold container a few inches above the eye control rate of flow by pressure on bottle flush affected area as needed With Cup rinse cup with clean water immediately before each use. Avoid contamination of rim and inside surfaceof cup fill cup half full with OcuFresh Eye Wash and apply the cup to the affected eye , pressing tightly to prevent escape of the liquid, and tilt the head backward open eyelids wide and rotate eyeball to ensure thorough bathing with the wash rinse cup with clean water after each use
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients: Sodium Chloride, Sodium Borate, Boric Acid, benzalkonium 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.Use: for cleaning the eye to help relieve irritation, discomfort, burning, stinging, smarting or itching by removing loose foreign material, air pollutants (smog or pollen) or chlorinated water.
Purpose
Information about the drug product’s indications for use.Purpose Eye Washing
Spl product data elements
Usually a list of ingredients in a drug product.OCUFRESH Water WATER WATER SODIUM CHLORIDE SODIUM BORATE BORIC ACID benzalkonium 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.OcuFresh product label OPTICS ® Laboratory OcuFresh ® Eye Wash The Safe Choice for Cleansing Your Eyes 60 Sterile Single-Use Bottles Each bottle contains: 20 ml (0.68 fl oz) OcuFresh® cleanses your eyes to remove loose foreign material, pollen or chlorinated water to help relieve your eyes from: Irritation • Stinging • Burning • Discomfort Manufactured for: Optics Laboratory, Inc., El Monte, CA 91731 USA Made ib Taiwan Optics Laboratory and ocufresh are trademarksof: Optics Laboratory, inc © 2015 Optics Laboratory, Inc. OPTICS ® Laboratory OcuFresh ® Eye Wash Sterile in Single-Use Bottles The Safe Choice for Cleansing Your Eyes 6 Sterile Single-Use Bottles Sterile Eye Cup Included Convenient and easy to carry Use only if tab and single-use bottles are intact res Optics OcuFresh 1 Optics Ocufresh 2
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 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 room temperature 15-30°C (59-86°F)
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? 800-968-6788
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: To avoid contamination, do not touch tip of the container to any surface. Do not reuse. Onced open, discard. if you experience eye pain, changes in vision, continued redness or irritation of the eye, or if the condition worsens or persists, consult a doctor obtain immediate medical treatment for all open wounds in or near the eye if solution changes colors or becomes cloudy, do not use.
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