Otc - Purpose
| Active Ingredients | Purpose |
| Olopatadine (0.7%) (equivalent to olopatadine hydrochloride 0.776%) | Antihistamine |
Pataday Once Daily Relief Solution
FDA Label NDC 0065-0816
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Alcon Laboratories, Inc. for the product Pataday Once Daily Relief (NDC 0065-0816). 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 - purpose, indications & usage, warnings, do not use, when using this product, otc - stop use, otc - keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Indications & Usage
Use temporarily relieves itchy 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) 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 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°-25°C (36°-77°F)
Inactive Ingredients
benzalkonium chloride 0.015%, boric acid, hydrochloric acid/sodium hydroxide (to adjust pH), hydroxypropylgamma- cyclodextrin, hypromellose, mannitol, polyethylene glycol 400, povidone, and purified water
Questions?
In the U.S., call 1-800-757-9195 or email [email protected]
Principal Display Panel
EXTRA STRENGTH
Pataday®
ONCE DAILY RELIEF
Olopatadine hydrochloride
ophthalmic solution 0.7%
Antihistamine
Eye Allergy Itch Relief
FULL 24 HOUR
Works in Minutes
Relief from Allergens:
• Pet Dander
• Pollen
• Grass
• Ragweed
Alcon
STERILE
2.5 mL (0.085 FL OZ)
EXTRA STRENGTH
Pataday®
ONCE DAILY RELIEF
TAMPER EVIDENT: For your protection, this bottle has a seal imprinted with Alcon around the neck. Do not use if seal is damaged or missing at time of purchase.
30 DAY SUPPLY
Eye Allergy Itch Relief
Works in Minutes
For Ages 2 and Older
________Fill Line________
Alcon Laboratories, Inc.
6201 South Freeway
Fort Worth, Texas 76134
Country of Origin: Japan
ACTUAL SIZE
NDC: 0065-0816-04
300038456-0620
LOT: EXP.:
3187
Carton (Carton)
EXTRA STRENGTH
Pataday®
ONCE DAILY RELIEF
Olopatadine hydrochloride
ophthalmic solution 0.7% Antihistamine
2.5 mL (0.085 FL OZ)
STERILE
Only for use in the eye.
Store between 2°– 25° C (36°– 77° F)
TAMPER EVIDENT: For your protection, this bottle has a seal imprinted with Alcon around the neck. Do not use if seal is damaged or missing at time of purchase.
Alcon Laboratories, Inc.
6201 South Freeway
Fort Worth, TX 76134
LOT: EXP.:
300038442-0620
Label (Label)
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