<content styleCode="bold">Ketotifen Fumarate Ophthalmic Solution</content>


  
    <content styleCode="bold">Ketotifen Fumarate Ophthalmic Solution</content>
  
  
  
  
  
    
    
      
        
        Sentiss Pharmaceuticals LLC
        
          
            
            SENTISS AG
            
              
                
                Ophtapharm AG
              
              
                
                  
                  
                    
                      
                        
                      
                    
                  
                
              
              
                
                  
                  
                    
                      
                        
                      
                    
                  
                
              
              
                
                  
                  
                    
                      
                        
                      
                    
                  
                
              
              
                
                  
                  
                    
                      
                        
                      
                    
                  
                
              
            
          
        
      
    
  
  
    
      
        
          
          
          
          
            
              
                
                Ketotifen Fumarate Ophthalmic Solution
                
                
                  
                    Ketotifen Fumarate
                  
                
                
                  
                    
                    BENZALKONIUM CHLORIDE
                  
                
                
                  
                    
                    GLYCERIN
                  
                
                
                  
                    
                    WATER
                  
                
                
                  
                    
                    HYDROCHLORIC ACID
                  
                
                
                  
                    
                    SODIUM HYDROXIDE
                  
                
                
                  
                    
                    
                  
                  
                    
                    KETOTIFEN FUMARATE
                    
                      
                        
                        KETOTIFEN
                      
                    
                  
                
                
                  
                    
                    
                  
                  
                    
                    
                    
                      
                        
                        
                      
                      
                        
                        
                      
                      
                        
                          
                          
                          
                            
                          
                        
                      
                    
                  
                  
                    
                      
                      
                    
                  
                
              
              
                
                  
                  
                  
                    
                      
                        
                      
                    
                  
                
              
              
                
                  
                  
                  
                    
                  
                
              
              
                
                  
                
              
            
          
        

      
      
        
          
          
          
            
              
                Drug Facts
              
            
          
          
        

      
      
        
          
          
          
            <content styleCode="italics">Active ingredient</content>
          
          
            Ketotifen (0.025%) 
  
  (equivalent to Ketotifen Fumarate 0.035%)
 
          
          
        

      
      
        
          
          
          
            <content styleCode="italics">Purpose</content>
          
          
            Antihistamine
          
          
        

      
      
        
          
          
          
            <content styleCode="italics">Use</content>
          
          
            Temporarily relieves itchy eyes due to pollen, ragweed, grass, animal hair and dander.
          
          
        

      
      
        
          
          
          
            <content styleCode="italics">Warnings</content>
          
          
            
              Do not use
            
            
              if solution changes color or becomes cloudy
              if you are sensitive to any ingredient in this product
              to treat contact lens related irritation
            
            
              When using this product
            
            
              do not touch tip of container to any surface to avoid contamination
              remove contact lenses before use
              wait at least 10 minutes before reinserting contact lenses after use
              replace cap after each use
            
            
              Stop use and ask a doctor ifyou experience any of the following:

 
            
              eye pain
              changes in vision
              redness of the eye
              itching worsens or lasts for more than 72 hours
            
          
          
          
            
              
              
              
                
                  Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

 
              
              
            

          
        

      
      
        
          
          
          
            <content styleCode="italics">Directions</content>
          
          
            
              
                Adults and children 3 years of age and older:Put 1 drop in the affected eye(s) twice daily, every 8-12 hours, no more than twice per day.
 
  
              
                Children under 3 years of age:Consult a doctor.
 
  
            
          
          
        

      
      
        
          
          
          
            <content styleCode="italics">Other information</content>
          
          
            
              Only for use in the eye.
              Store at 20° to 25°C (68° TO 77°F) [see USP Controlled Room Temperature].
            
          
          
        

      
      
        
          
          
          
            <content styleCode="italics">Inactive ingredients</content>
          
          
            Benzalkonium Chloride 0.01%; Glycerin and Water for Injection. May contain Hydrochloric Acid and/or Sodium Hydroxide (to adjust pH).
          
          
        

      
      
        
          
          
          
            <content styleCode="italics">Questions?</content>
          
          
            call toll-free
 
  1-855-473-6847,weekdays, 7:00 AM - 5:30 PM CT

 
          
          
        

      
      
        
          
          
          
          <text>
            <paragraph>
              <content styleCode="bold">Now
  
   <content styleCode="italics">OTC!</content>
              </content>
            </paragraph>
            <paragraph>
              <content styleCode="bold">ANTIHISTAMINE EYE DROPS</content>
            </paragraph>
            <paragraph>
              <content styleCode="bold">UPTO 12 HOURS EYE ITCH RELIEF</content>
            </paragraph>
            <paragraph>•
 
  <content styleCode="bold">Works in Minutes</content>
            </paragraph>
            <paragraph>•
 
  <content styleCode="bold">Original Prescription Strength</content>
            </paragraph>
            <paragraph>
              <content styleCode="bold">FOR AGES 3 YEARS AND OLDER</content>
              <br/>
              <content styleCode="bold">30 DAY SUPPLY</content>
            </paragraph>
            <paragraph>
              <content styleCode="bold">Sterile</content>
            </paragraph>
            <paragraph>
              <content styleCode="bold">Original Prescription Strength</content>
            </paragraph>
            <paragraph>
              <content styleCode="bold">Do not use if seal on bottle is missing or broken.</content>
            </paragraph>
            <paragraph>
              <content styleCode="bold">FOR TOPICAL OPHTHALMIC USE ONLY.</content>
            </paragraph>
            <paragraph>
              <content styleCode="bold">PRECAUTION: Do not touch dropper tip to any surface, as this may contaminate the solution.</content>
            </paragraph>
            <paragraph>
              <content styleCode="bold">Distributed by: Sentiss Pharmaceuticals, LLC 
   <br/>  San Clemente, CA 92672 (USA)
  </content>
            </paragraph>
            <paragraph>
              <content styleCode="bold">Manufactured by: Ophtapharm AG, Riethofstrasse 1, 
   <br/>  Hettlingen, 8442, Switzerland (CHE) 
  </content>
            </paragraph>
            <paragraph>
              <content styleCode="bold">Made in Switzerland</content>
            </paragraph>
          </text>
          <effectiveTime value="20260415"/>
        </section>
      </component>
      <component>
        <section ID="L2d20abce-dd84-4154-af71-2c7e3a308b75">
          <id root="4f82e49c-1d06-a62b-e063-6394a90a9a6c"/>
          <code code="51945-4" codeSystem="2.16.840.1.113883.6.1" displayName="PACKAGE LABEL.PRINCIPAL DISPLAY PANEL"/>
          <title>Packaging
          
            
              
            
          
          
          
            
              Ketolbl3