FDA Label for Quality Choice Lubricant Tears Eye

View Indications, Usage & Precautions

Quality Choice Lubricant Tears Eye Product Label

The following document was submitted to the FDA by the labeler of this product Chain Drug Marketing Association Inc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Otc - Active Ingredient



Active ingredients                                                                             Purpose

Glycerin 0.2%..................................................................................Lubricant

Hypromellose 0.2%..........................................................................Lubricant

Polyethylene glycol 400 1%..............................................................Lubricant


Otc - Purpose



Uses

  • for the temporary relief of burning and irritation due to dryness of the eye
  • for protection against further irritation

Warnings



Warnings

For external use only.


Otc - Do Not Use



Do not use:

  • if this solution changes color or becomes cloudy or if you are sensitive to any ingredient in this product

Otc - When Using



When using this product

  • remove contact lenses before use
  • do not use if this solution changes color or becomes cloudy
  • do not touch tip of container to any surface to avoid contamination
  • replace cap after each use

Otc - Stop Use



Stop use and ask a doctor if

  • you feel eye pain
  • changes in vision occur
  • redness or irritation of the eye lasts
  • condition worsens or lasts more than 72 hours

Otc - Pregnancy Or Breast Feeding



If pregnant or breast-feeding,

ask a health professional before use.


Otc - 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


Indications & Usage



Directions

  • Instill 1 or 2 drops in the affected eye(s) as needed.
  • children under 6 years of age: ask a doctor

Storage And Handling



Other information

  • some users may experience a brief tingling sensation
  • store at 15o to 25oC (59o to 77oF)

Inactive Ingredient



Inactive ingredients

benzalkonium chloride, boric acid, dextrose, glycine, magnesium chloride, potassium chloride, purified water, sodium borate, sodium chloride, sodium citrate, sodium lactate.


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




* Please review the disclaimer below.