Quality Choice Lubricating Eye Drops
FDA Label NDC 63868-969

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Chain Drug Marketing Association Inc for the product Quality Choice Lubricating Eye Drops (NDC 63868-969). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, warnings, otc - when using, otc - stop use, otc - keep out of reach of children, indications & usage, storage and handling, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active ingredients------------------------------------------------Purpose

Carboxymethylcellulose Sodium 0.5%-------------------Lubricant

Glycerin 0.9%-----------------------------------------------------Lubricant

Otc - Purpose

Uses

  • For the temporary relief of burning, irritation and discomfort due to dryness of the eye or from irritation from wind or sun.

Warnings

Warnings

  • For external use only

Otc - When Using


When using this product

  • To avoid contamination, do not touch tip of container to any surface.  Replace cap after using.
  • Do not use if solution changes color or gets cloudy.

Otc - Stop Use

Stop use and ask a doctor if

You feel eye pain, changes in vision, continued redness, or irritation of the eye, or if the condition worsens or persists for more than 72 hours.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center immediately.

Indications & Usage

Directions

Put 1 or 2 drops in the affected eye/s as needed.

Storage And Handling

Other information

  • some users may experience a brief tingling sensation
  • Store at room temperature.

Inactive Ingredient

Inactive ingredients:

Boric Acid, Sodium Borate, Levocarnitin, Potassium Chloride, Calcium Chloride Dihydrate, Magnesium Chloride, Erythritol, Sodium Citrate Dihydrate, Potassium Sorbate, Purified Water

Dosage & Administration

Distributed by C.D.M.A., Inc.

43157 W. Nine Mile

Novi, MI 48376-0995

www.qualitychoice.com

Made in Korea

Package Label.Principal Display Panel

Image Of Carton Label (Qclubricatingeyedrops)

Image Of Carton Label (Qclubricatingeyedrops)

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