FDA Label for Olopatadine Hydrochloride
View Indications, Usage & Precautions
Olopatadine Hydrochloride Product Label
The following document was submitted to the FDA by the labeler of this product Strategic Sourcing Services 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.
Otc - Purpose
Active Ingredient | Purpose |
Olopatadine (0.1%). | Antihistamine and redness reliever |
Indications & Usage
Uses
temporarily relieves itchy and red eyes due to pollen, ragweed, grass, animal hair and dander
Warnings
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
Otc - Stop Use
Stop use and ask a doctor if you experience:
• eye pain• changes in vision• increased redness of the eye• itching worsens or lasts for more than 72 hours
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.
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°C to 25°C (39°F to 77°F)
Inactive Ingredients
benzalkonium chloride 0.01%, dibasic sodium phosphate, hydrochloric acid and/ or sodium hydroxide (to adjust PH), sodium chloride and water for injection.
Questions Or Comments?
In the U.S., call Monday to Friday 9:00am to 7:00pm EST.at (833) 358-6431.
Distributed by:
McKesson Corp.,
Via Strategic Sourcing Services LLC.
Memphis, TN 38141
Product of Spain
February 2025
Principal Display Panel
NDC 70677-1280-1
Olopatadine hydrochloride ophthalmic solution 0.1%
Antihistamine and Redness Reliever
Twice Daily Relief
Eye Allergy Itch & Redness Relief
5 mL
STERILE
NDC 70677-1280-1
Olopatadine hydrochloride ophthalmic solution 0.1%
Antihistamine and Redness Reliever
Twice Daily Relief
Eye Allergy Itch & Redness Relief
5 mL
STERILE
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