FDA Label for Redness Reliever And Lubricant

View Indications, Usage & Precautions

Redness Reliever And Lubricant Product Label

The following document was submitted to the FDA by the labeler of this product Promex, Llc. 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.

Active Ingredient



Dextran 70 0.1%

Polyethylene Glycol 400 1%

Povidone 1%

Tetrahydrozoline HCl 0.5%


Purpose



Lubricant

Lubricant

Lubricant

Redness reliever


Use



  • for the relief of redness of the eye due to minor eye irritations
  • for use as a protectant against further irritation or to relieve dryness of the eye

Warnings



Ask a doctor before use if you have narrow angle glaucoma


When Using This Product



  • pupils may become enlarged temporarily
  • overuse may cause more eye redness
  • remove contact lenses before using
  • do not use if this solution changes color or become cloudy
  • 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 feel eye pain
  • changes in vision occur
  • redness or irritation of the eye lasts
  • condition worsens or lasts more than 72 hours

If Pregnant Or Breast-Feeding,



ask a health professional before use.


Keep Out Of Reach Of Children.



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


Directions



  • Put 1 to 2 drops in the affected eye(s) up to 4 times daily
  • children under 6 years of age:  ask a doctor

Other Information



  • store at 15-30 °C (59-86 °F)


Inactive Ingredients



benzalkonium chloride, boric acid, edetate disodium,  purified water, sodium borate, and sodium chloride


Package Label



Redness Reliever and Lubricant


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