Active Ingredient(S)
Olopatadine (01.%) (equivalent to olopatadine hydrochloride 0.111%)
Olopatadine Hydrochloride Solution/ Drops
FDA Label NDC 69168-480
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Allegiant Health for the product Olopatadine Hydrochloride (NDC 69168-480). 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 active ingredient(s), purpose, use(s), warnings, do not use if you have, when using this product, stop use and ask a doctor if, 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
Purpose
Antihistamine and redness reliever
Use(S)
Temporarily relieves itchy and red eyes due to pollen, ragweed, grass, animal hair and dander.
Warnings
For external use only
Do Not Use If You Have
- 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
- 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 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%, hydrochloric acid/sodium hydroxide (adjust pH), sodium phosphate
dibasic (anhydrous), sodium chloride and water for injection.
Questions/Comments
Call 1-888-952-0050
(Monday-Friday 9 AM – 5 PM EST)
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