drug facts

Composition & Product

Active Ingredients

olopatadine (2 mg)

Inactive Ingredients

povidone, unspecified sodium phosphate, dibasic, unspecified form sodium chloride edetate disodium benzalkonium chloride hydrochloric acid sodium hydroxide water

Identifiers & Packaging

Marketing Status

nda active Since 2020-02-28

Medication Information

Warnings and Precautions

Warnings

For external use only

Indications and Usage

Use temporarily relieves itchy eyes due to pollen, ragweed, grass, animal hair and dander

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°-25°C (36°-77°F)

Inactive Ingredients

benzalkonium chloride 0.01%, dibasic sodium phosphate, edetate disodium, hydrochloric acid/sodium hydroxide (adjust pH), povidone, purified water, and sodium chloride

Description

Active Ingredients Purpose Olopatadine 0.2% (equivalent to olopatadine hydrochloride 0.222%) Antihistamine

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

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 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.:

300071825

-0425

Original Prescription Strength

Pataday _®

ONCE DAILY RELIEF

Olopatadine hydrochloride

ophthalmic solution 0.2%

Antihistamine

Eye Allergy Itch Relief

ONCE

DAILY

#1 DOCTOR RECOMMENDED

OTC EYE ALLERGY

BRAND*

Works in Minutes

Alcon

STERILE

2.5 mL (0.085 fl oz)

LOT: EXP:

Pataday _®

ONCE DAILY RELIEF

Olopatadine hydrochloride

ophthalmic solution 0.7% Antihistamine

Eye Allergy Itch Relief

Pataday _®

ONCE DAILY RELIEF

Eye Allergy Itch Relief

Works in minutesTAMPER EVIDENT: For your protection,

this bottle has a seal imprinted 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: 0065-8150-01 300071461-0325

*Based on a survey of eye care professionals,

allergist, and primary care doctors. December 2024.

Questions?

In the U.S., call 1-800-757-9195 or email [email protected]

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

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

Section 55105-1

Active Ingredients	Purpose
Olopatadine 0.2% (equivalent to olopatadine hydrochloride 0.222%)	Antihistamine

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

Structured Label Content

Warnings and Precautions (34071-1)

Warnings

For external use only

Indications and Usage (34067-9)

Use temporarily relieves itchy eyes due to pollen, ragweed, grass, animal hair and dander

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 (Other information)

only for use in the eye
store between 2°-25°C (36°-77°F)

Inactive Ingredients (Inactive ingredients)

benzalkonium chloride 0.01%, dibasic sodium phosphate, edetate disodium, hydrochloric acid/sodium hydroxide (adjust pH), povidone, purified water, and sodium chloride

Principal Display Panel (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

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 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.:

300071825

-0425

Original Prescription Strength

Pataday _®

ONCE DAILY RELIEF

Olopatadine hydrochloride

ophthalmic solution 0.2%

Antihistamine

Eye Allergy Itch Relief

ONCE

DAILY

#1 DOCTOR RECOMMENDED

OTC EYE ALLERGY

BRAND*

Works in Minutes

Alcon

STERILE

2.5 mL (0.085 fl oz)

LOT: EXP:

Pataday _®

ONCE DAILY RELIEF

Olopatadine hydrochloride

ophthalmic solution 0.7% Antihistamine

Eye Allergy Itch Relief

Pataday _®

ONCE DAILY RELIEF

Eye Allergy Itch Relief

Works in minutesTAMPER EVIDENT: For your protection,

this bottle has a seal imprinted 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: 0065-8150-01 300071461-0325

*Based on a survey of eye care professionals,

allergist, and primary care doctors. December 2024.

Questions?

In the U.S., call 1-800-757-9195 or email [email protected]

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

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

Section 55105-1 (55105-1)

Active Ingredients	Purpose
Olopatadine 0.2% (equivalent to olopatadine hydrochloride 0.222%)	Antihistamine

Do Not Use (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 (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

Advanced Ingredient Data

[{"name": "Olopatadine", "unii": "D27V6190PM", "classCode": "ACTIM", "strengthNumerator": "2", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "Povidone, Unspecified", "unii": "FZ989GH94E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Sodium Phosphate, Dibasic, Unspecified Form", "unii": "GR686LBA74", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Sodium Chloride", "unii": "451W47IQ8X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Edetate Disodium", "unii": "7FLD91C86K", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Benzalkonium Chloride", "unii": "F5UM2KM3W7", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Hydrochloric Acid", "unii": "QTT17582CB", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Sodium Hydroxide", "unii": "55X04QC32I", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Water", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Use temporarily relieves itchy eyes due to pollen, ragweed, grass, animal hair and dander", "34071-1": "Warnings For external use only", "50565-1": "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.", "50566-9": "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", "55105-1": "Active Ingredients Purpose Olopatadine 0.2% (equivalent to olopatadine hydrochloride 0.222%) Antihistamine", "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", "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", "Questions?": "In the U.S., call 1-800-757-9195 or email alcon.medinfo@alcon.com", "Other information": "only for use in the eye store between 2°-25°C (36°-77°F)", "Inactive ingredients": "benzalkonium chloride 0.01%, dibasic sodium phosphate, edetate disodium, hydrochloric acid/sodium hydroxide (adjust pH), povidone, purified water, and sodium chloride", "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 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 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.: 300071825 -0425 Original Prescription Strength Pataday ® ONCE DAILY RELIEF Olopatadine hydrochloride ophthalmic solution 0.2% Antihistamine Eye Allergy Itch Relief ONCE DAILY #1 DOCTOR RECOMMENDED OTC EYE ALLERGY BRAND* Works in Minutes Alcon STERILE 2.5 mL (0.085 fl oz) LOT: EXP: Pataday ® ONCE DAILY RELIEF Olopatadine hydrochloride ophthalmic solution 0.7% Antihistamine Eye Allergy Itch Relief Pataday ® ONCE DAILY RELIEF Eye Allergy Itch Relief Works in minutes TAMPER EVIDENT: For your protection, this bottle has a seal imprinted 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: 0065-8150-01 300071461-0325 *Based on a survey of eye care professionals, allergist, and primary care doctors. December 2024.", "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"}