1. Home
  2. Labeler Index
  3. Cardinal Health, 110 Dba Leader
  4. 70000-0087
  5. Label Information: Eyes Irritation Relief

FDA Label for Eyes Irritation Relief

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS
    2. PURPOSE
    3. ACTIVE INGREDIENT
    4. USES
    5. WARNINGS
    6. DO NOT USE IF
    7. ASK A DOCTOR BEFORE USE IF YOU HAVE
    8. WHEN USING THIS PRODUCT
    9. STOP USE & ASK A DOCTOR IF
    10. KEEP OUT OF REACH OF CHILDREN.
    11. DIRECTIONS
    12. OTHER INFORMATION
    13. INACTIVE INGREDIENTS
    14. PRINCIPAL DISPLAY PANEL

Eyes Irritation Relief Product Label

The following document was submitted to the FDA by the labeler of this product Cardinal Health, 110 Dba Leader. 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 Ingredients



Polyvinyl alcohol 0.5%

Povidone 0.6%


Purpose



Lubricant

Redness reliever


Active Ingredient



Tetrahydrozoline hydrochloride 0.05%


Uses



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

Warnings



For external use only


Do Not Use If



solution changes color or becomes cloudy.


Ask A Doctor Before Use If You Have



narrow angle glaucoma.


When Using This Product



  • to avoid contamination, do not touch tip to any surface
  • replace cap after using
  • overuse may produce increased redness of the eye
  • pupils may become enlarged temporarily

Stop Use & Ask A Doctor If



  • you experience eye pain
  • you experience changes in vision
  • you experience continued redness or irritation of the eye
  • the condition worsens
  • symptoms last for more than 72 hours

Keep Out Of Reach Of Children.



If swallowed, get medical help or contact a Poison Control Center(1-800-222-1222) right away.


Directions



Instill 1 to 2 drops in the affected eye(s) up to four times daily.


Other Information



  • store at room temperature
  • remove contact lenses before using

Inactive Ingredients



Benzalkonium Chloride,  Disodium Hydrogen Phosphate Anhydrous, Disodium Edetate, Mannitol , Potassium Chloride, Purified Water, Sodium dihydrogen Phosphate Dihydrate, Sodium Chloride, Sodium Citrate , May Contain Hydrochloric Acid and/or Sodium Hydroxide to Adjust PH.


Principal Display Panel



1 - 1

1 - 1


* Please review the disclaimer below.