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 Bausch & Lomb Incorporated. 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 (0.2%)
(equivalent to olopatadine hydrochloride 0.222%)
Purpose
Antihistamine
Uses
temporarily relieves itchy 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 If You 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) once daily, no more than once 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, edetate disodium, hydrochloric acid/sodium hydroxide (to adjust pH), povidone, sodium chloride and water for injection
Questions?
Call 1-800-553-5340
Package/Label Principal Display Panel
Compare to the active ingredient in
Pataday Once Daily Relief*
BAUSCH + LOMB
NDC 24208-617-01
Olopatadine
Hydrochloride
Ophthalmic
Solution USP, 0.2%
Antihistamine
Eye Allergy Itch Relief
ONCE DAILY
Works in Minutes
Relief from Allergens:
• Pet Dander • Pollen
• Grass • Ragweed
STERILE
3.5 ml (0.12 FL OZ)
ORIGINAL
PRESCRIPTION
STRENGTH
3912400
AB61705
*This product is not manufactured or distributed by
Alcon owner of the trademark Pataday.
* Please review the disclaimer below.
