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  5. Label Information: Leader Olopatadine Hydrochloride Ophthalmic Solution

FDA Label for Leader Olopatadine Hydrochloride Ophthalmic Solution

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. DO NOT USE
    6. KEEP OUT OF REACH OF CHILDREN.
    7. DIRECTIONS
    8. OTHER INFORMATION
    9. INACTIVE INGREDIENTS
    10. QUESTIONS?

Leader Olopatadine Hydrochloride Ophthalmic Solution Product Label

The following document was submitted to the FDA by the labeler of this product Cardinal Health. 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



Olopatadine (0.1%)

(equivalent to olopatadine hydrochloride 0.111%)


Purpose



Antihistamine and Redness Reliever


Uses



temporarily relieves itchy and red eyes due to pollen, ragweed, grass, animal hair and dander


Warnings



For external use only


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
  • do not wear a contact lens if your eye is red
  • Stop use and ask a doctor ifyou experience:
  • eye pain
  • changes in vision
  • increased 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.


Directions



  • adults and children 2 years of age and older:
  • put 1 drop in the affected eye(s) twice daily, every 6 to 8 hours, no more than twice per day
  • if using other ophthalmic products while using this product, wait at least 5 minutes between each product
  • replace cap after each use
  • children under 2 years of age:consult a doctor

Other Information



  • only for use in the eye
  • store between 4-25 °C (39-77 °F)
  • protect from light

Inactive Ingredients



benzalkonium chloride 0.01%, dibasic sodium phosphate, hydrochloric acid/sodium hydroxide (to adjust pH), sodium chloride and water for injection


Questions?



Call1-877-758-1480


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