FDA Label for Olopatadine Hydrochloride Ophthalmic Solution
View Indications, Usage & Precautions
Olopatadine Hydrochloride Ophthalmic Solution Product Label
The following document was submitted to the FDA by the labeler of this product Gland Pharma Limited. 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 (0.7%)............(equivalent to olopatadine hydrochloride 0.776%)
Purpose
Antihistamine
Use
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
- do not use more than 1 drop in each eye per day
- if using other ophthalmic products while using this product, wait at least 5minutes 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 2° - 25°C (36° - 77°F)
Inactive Ingredients
benzalkonium chloride 0.015% (preservative), boric acid, hydrochloric acid/sodium hydroxide (to adjust pH), hydroxypropyl-gamma-cyclodextrin, hypromellose, mannitol, polyethylene glycol 400, povidone, and purified water.
Questions?
call 866-770-7144 (Monday – Friday 9:00 AM to 6:00 PM EST)
Principal Display Panel
Carton Label:
EXTRA STRENGTH
NDC 68083-398-01
Olopatadine
Hydrochloride
Ophthalmic
Solution, USP
0.7%
Antihistamine
ONCE DAILY RELIEF
Eye Allergy Itch Relief
FULL
24
HOUR
Works in Minutes
2.5 mL (0.085 fl oz)
STERILE
Bottle Label:
NDC 68083-398-01
EXTRA STRENGTH
Olopatadine
Hydrochloride
Ophthalmic
Solution, USP
0.7%
Antihistamine
ONCE DAILY RELIEF
EYE ALLERGY ITCH RELIEF
STERILE
2.5 mL (0.085 fl oz)
* Please review the disclaimer below.
