Version
v6
Effective date
December 15, 2023
Original packager
Yes
Sections captured
15
Identifiers
- Document ID
- 30e4fc2d-7d06-477a-9160-aa231b83e642
- Set ID
- 1c7d2342-ba1c-4244-9814-d92a05725d4e
- Application numbers
- NDA021545
- Product NDCs
- 0065-8150
- Package NDCs
- 0065-8150-01, 0065-8150-03, 0065-8150-04, 0065-8150-07
- Original packager NDCs
- —
Names & Manufacturers
- Brand names
- PATADAY ONCE DAILY RELIEF
- Generic names
- OLOPATADINE HYDROCHLORIDE
- Manufacturer names
- Alcon Laboratories, Inc.
- Product types
- HUMAN OTC DRUG
Substances & Pharmacology
- Substance names
- OLOPATADINE HYDROCHLORIDE
- Routes
- OPHTHALMIC
- Pharmacologic class (PE)
- —
- Pharmacologic class (EPC)
- —
- Pharmacologic class (CS)
- —
- Mechanism of action
- —
Other identifiers
- NUI
- —
- RxCUI
- 1111343, 1111345
- UNII
- 2XG66W44KF
- UPC
- —
Structured Label Sections
Active Ingredient (1)
Sequence 1
Active Ingredients Purpose Olopatadine 0.2% (equivalent to olopatadine hydrochloride 0.222%) Antihistamine
Active Ingredient Table (1)
Sequence 1
Active Ingredients | Purpose |
Olopatadine 0.2% (equivalent to olopatadine hydrochloride 0.222%) | Antihistamine |
Do Not Use (2)
Sequence 1
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
Sequence 2
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
Dosage And Administration (1)
Sequence 1
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
Inactive Ingredient (1)
Sequence 1
Inactive ingredients benzalkonium chloride 0.01%, dibasic sodium phosphate, edetate disodium, hydrochloric acid/sodium hydroxide (adjust pH), povidone, purified water, and sodium chloride
Indications And Usage (1)
Sequence 1
Use temporarily relieves itchy eyes due to pollen, ragweed, grass, animal hair and dander
Keep Out Of Reach Of Children (1)
Sequence 1
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Package Label Principal Display Panel (1)
Sequence 1
PRINCIPAL DISPLAY PANEL Pataday ® ONCE DAILY RELIEF Olopatadine hydrochloride ophthalmic solution 0.2% Antihistamine 2.5 mL (0.085 FL OZ) STERILE EYE ALLERGY ITCH RELIEF 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. Fort Worth, TX 76134 LOT: EXP.: H15725-219 Original Prescription Strength Pataday ONCE DAILY RELIEF Olopatadine hydrochloride ophthalmic solution 0.2% Antihistamine Eye Allergy Itch Relief ONCE DAILY Works in Minutes Relief from Allergens: Pet Dander Pollen Grass Ragweed STERILE 2.5 mL (0.085 FL OZ) Alcon Pataday ONCE DAILY RELIEF Eye Allergy Itch Relief Works in Minutes 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. For Ages 2 and Older 30 DAY SUPPLY ________Fill Line________ Alcon Laboratories, Inc. 6201 South Freeway Fort Worth, Texas 76134 Country of Origin: Japan ACTUAL SIZE NDC: 0065-6150-01 300037159-0520
Purpose (1)
Sequence 1
Active Ingredients Purpose Olopatadine 0.2% (equivalent to olopatadine hydrochloride 0.222%) Antihistamine
Purpose Table (1)
Sequence 1
Active Ingredients | Purpose |
Olopatadine 0.2% (equivalent to olopatadine hydrochloride 0.222%) | Antihistamine |
Questions (1)
Sequence 1
Questions? In the U.S., call 1-800-757-9195 or email alcon.medinfo@alcon.com
Spl Product Data Elements (1)
Sequence 1
PATADAY ONCE DAILY RELIEF OLOPATADINE HYDROCHLORIDE Olopatadine Hydrochloride Olopatadine Povidone, Unspecified Sodium Phosphate, Dibasic, Unspecified Form Sodium Chloride Edetate Disodium Benzalkonium Chloride Hydrochloric Acid Sodium Hydroxide Water label 300037159-0520
Stop Use (1)
Sequence 1
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
Storage And Handling (1)
Sequence 1
Other information only for use in the eye store between 2°-25°C (36°-77°F)
Warnings (1)
Sequence 1
Warnings For external use only
OpenFDA raw payload
{'application_number': ['NDA021545'],
'brand_name': ['PATADAY ONCE DAILY RELIEF'],
'generic_name': ['OLOPATADINE HYDROCHLORIDE'],
'is_original_packager': [True],
'manufacturer_name': ['Alcon Laboratories, Inc.'],
'package_ndc': ['0065-8150-01',
'0065-8150-03',
'0065-8150-04',
'0065-8150-07'],
'product_ndc': ['0065-8150'],
'product_type': ['HUMAN OTC DRUG'],
'route': ['OPHTHALMIC'],
'rxcui': ['1111343', '1111345'],
'spl_id': ['30e4fc2d-7d06-477a-9160-aa231b83e642'],
'spl_set_id': ['1c7d2342-ba1c-4244-9814-d92a05725d4e'],
'substance_name': ['OLOPATADINE HYDROCHLORIDE'],
'unii': ['2XG66W44KF']}