Otc - Active Ingredient
Active Ingredients - Purpose - Olopatadine 0.2% (equivalent to olopatadine hydrochloride 0.222%) Antihistamine
Olopatadine Hydrochloride Solution
FDA Label NDC 73581-709
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Yyba Corp for the product Olopatadine Hydrochloride (NDC 73581-709). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, use, warnings, do not use, when using this product, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
| Active Ingredients | Purpose |
| Olopatadine 0.2%
(equivalent to olopatadine hydrochloride 0.222%) | 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
Otc - Stop Use
Stop use and ask a doctor if
- 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) 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 2°C to 25°C (36°F to 77°F)
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?
In the U.S., call toll free weekdays 9 AM to 6 PM EST at 1 (866) 933-6337.
Distributed by:
Wellspring Meds USA
Airmont, NY 10952
Package Label.Principal Display Panel
Olopatadine hydrochloride
ophthalmic solution 0.2%
Antihistamine
2.5 mL
STERILE
EYE ALLERGY ITCH RELIEF
Original Prescription Strength
ONCE DAILY RELIEF
Olopatadine hydrochloride ophthalmic solution 0.2%
Antihistamine
Eye Allergy Itch Relief
STERILE
2.5 mL
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