Drug Facts

Composition & Product

Active Ingredients

Olopatadine (1 mg)

Inactive Ingredients

Sodium Phosphate, Dibasic, Unspecified Form Sodium Chloride Benzalkonium Chloride Hydrochloric Acid Sodium Hydroxide Water

Identifiers & Packaging

Marketing Status

NDA Active Since 2020-02-25

Medication Information

Warnings and Precautions

Warnings

For external use only

Indications and Usage

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

Description

Active Ingredients Purpose Olopatadine (0.1%). (equivalent to olopatadine hydrochloride 0.111%) Antihistamine and Redness Reliever

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 (0.1%). (equivalent to olopatadine hydrochloride 0.111%)	Antihistamine and Redness Reliever

Directions

adults and children 2 years of age 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

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 [email protected]

Alcon Laboratories, Inc.

6201 South Freeway

Fort Worth, Texas 76134

Country of Origin: Japan

NDC: 0065-4274-01

9017919-1219

Other Information

only for use in the eye
store between 4°-25°C (39°-77°F)

Inactive Ingredients

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

Principal Display Panel

Original Prescription Strength

Pataday ^®

TWICE DAILY RELIEF

Olopatadine hydrochloride

ophthalmic solution 0.1%

Antihistamine and Redness Reliever

Eye Allergy Itch & Redness Relief

TWICE DAILY

Works in Minutes

Relief from Allergens:

   • Pet Dander

   • Pollen

    • Grass

   • Ragweed

STERILE

5 mL (0.17 FL OZ)

Alcon

Pataday ^®

TWICE DAILY RELIEF

Eye Allergy Itch & Redness Relief

Works in Minutes

For Ages 2 and Older

30 DAY SUPPLY

TAMPER EVIDENT: For your protection, this bottle has a seal imprinted with Alcon around the neck.

________Fill Line________

Do not use if seal is damaged or missing at time of purchase.

ACTUAL SIZE

Alcon Laboratories, Inc.

6201 South Freeway

Fort Worth, Texas 76134

Country of Origin: Japan

NDC: 0065-4274-01

300036779-0320

LOT:     EXP.:

Pataday ^®

TWICE DAILY RELIEF

Olopatadine hydrochloride

ophthalmic solution 0.1%

Antihistamine and Redness Reliever

Eye Allergy Itch & Redness Relief

5 mL (0.17 FL OZ)

STERILE

Only for use in the eye.

Store between 4° – 25° C (39° – 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.:

H15723-1219

Original Prescription Strength

Pataday _®

TWICE DAILY RELIEF

Olopatadine hydrochloride

ophthalmic solution 0.1%

Antihistamine and Redness Reliever

Eye Allergy Itch & Redness Relief

TWICE

DAILY

#1 DOCTOR RECOMMENDED

OTC EYE ALLERGY

BRAND*

Works in Minutes

STERILE

5 mL (0.17 fl oz)

Alcon

LOT:     EXP.:

Pataday _®

TWICE DAILY RELIEF

Eye Allergy Itch & Redness Relief

Works in Minutes

For Ages 2

and Older

30 DAY

SUPPLY

TAMPER EVIDENT:

For your protection,

this bottle has a seal

imprinted

around the neck.

________Fill Line________

Do not use if seal is

damaged or missing at

time of purchase.

ACTUAL SIZE

*Based on a survey of eye care professionals,

allergists, and primary care doctors. December 2024.

Alcon Laboratories, Inc.

6201 South Freeway

Fort Worth, Texas 76134

Country of Origin: Japan

NDC: 0065-4274-01

300071456-0325

Pataday _®

TWICE DAILY RELIEF

Olopatadine hydrochloride

ophthalmic solution 0.1%

Antihistamine and Redness Reliever

Eye Allergy Itch & Redness Relief

5 mL (0.17 fl oz) STERILE

Only for use in the eye.

Store between 4° – 25° C

(39° – 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.

6201 South Freeway

Fort Worth, TX 76134

LOT: EXP.:

300071824-0425

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

Indications and Usage (34067-9)

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

Warnings and Precautions (34071-1)

Warnings

For external use only

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 (0.1%). (equivalent to olopatadine hydrochloride 0.111%)	Antihistamine and Redness Reliever

Directions

adults and children 2 years of age 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

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

Questions?

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

Alcon Laboratories, Inc.

6201 South Freeway

Fort Worth, Texas 76134

Country of Origin: Japan

NDC: 0065-4274-01

9017919-1219

Other Information (Other information)

only for use in the eye
store between 4°-25°C (39°-77°F)

Inactive Ingredients (Inactive ingredients)

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

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Original Prescription Strength

Pataday ^®

TWICE DAILY RELIEF

Olopatadine hydrochloride

ophthalmic solution 0.1%

Antihistamine and Redness Reliever

Eye Allergy Itch & Redness Relief

TWICE DAILY

Works in Minutes

Relief from Allergens:

   • Pet Dander

   • Pollen

    • Grass

   • Ragweed

STERILE

5 mL (0.17 FL OZ)

Alcon

Pataday ^®

TWICE DAILY RELIEF

Eye Allergy Itch & Redness Relief

Works in Minutes

For Ages 2 and Older

30 DAY SUPPLY

TAMPER EVIDENT: For your protection, this bottle has a seal imprinted with Alcon around the neck.

________Fill Line________

Do not use if seal is damaged or missing at time of purchase.

ACTUAL SIZE

Alcon Laboratories, Inc.

6201 South Freeway

Fort Worth, Texas 76134

Country of Origin: Japan

NDC: 0065-4274-01

300036779-0320

LOT:     EXP.:

Pataday ^®

TWICE DAILY RELIEF

Olopatadine hydrochloride

ophthalmic solution 0.1%

Antihistamine and Redness Reliever

Eye Allergy Itch & Redness Relief

5 mL (0.17 FL OZ)

STERILE

Only for use in the eye.

Store between 4° – 25° C (39° – 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.:

H15723-1219

Original Prescription Strength

Pataday _®

TWICE DAILY RELIEF

Olopatadine hydrochloride

ophthalmic solution 0.1%

Antihistamine and Redness Reliever

Eye Allergy Itch & Redness Relief

TWICE

DAILY

#1 DOCTOR RECOMMENDED

OTC EYE ALLERGY

BRAND*

Works in Minutes

STERILE

5 mL (0.17 fl oz)

Alcon

LOT:     EXP.:

Pataday _®

TWICE DAILY RELIEF

Eye Allergy Itch & Redness Relief

Works in Minutes

For Ages 2

and Older

30 DAY

SUPPLY

TAMPER EVIDENT:

For your protection,

this bottle has a seal

imprinted

around the neck.

________Fill Line________

Do not use if seal is

damaged or missing at

time of purchase.

ACTUAL SIZE

*Based on a survey of eye care professionals,

allergists, and primary care doctors. December 2024.

Alcon Laboratories, Inc.

6201 South Freeway

Fort Worth, Texas 76134

Country of Origin: Japan

NDC: 0065-4274-01

300071456-0325

Pataday _®

TWICE DAILY RELIEF

Olopatadine hydrochloride

ophthalmic solution 0.1%

Antihistamine and Redness Reliever

Eye Allergy Itch & Redness Relief

5 mL (0.17 fl oz) STERILE

Only for use in the eye.

Store between 4° – 25° C

(39° – 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.

6201 South Freeway

Fort Worth, TX 76134

LOT: EXP.:

300071824-0425

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": "1", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"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": "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 and red 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 (0.1%). (equivalent to olopatadine hydrochloride 0.111%) Antihistamine and Redness Reliever", "Directions": "adults and children 2 years of age 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", "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 Alcon Laboratories, Inc. 6201 South Freeway Fort Worth, Texas 76134 Country of Origin: Japan NDC: 0065-4274-01 9017919-1219", "Other information": "only for use in the eye store between 4°-25°C (39°-77°F)", "Inactive ingredients": "benzalkonium chloride 0.01%, dibasic sodium phosphate, hydrochloric acid/sodium hydroxide (adjust pH), purified water, and sodium chloride", "PRINCIPAL DISPLAY PANEL": "Original Prescription Strength Pataday ® TWICE DAILY RELIEF Olopatadine hydrochloride ophthalmic solution 0.1% Antihistamine and Redness Reliever Eye Allergy Itch & Redness Relief TWICE DAILY Works in Minutes Relief from Allergens: • Pet Dander • Pollen • Grass • Ragweed STERILE 5 mL (0.17 FL OZ) Alcon Pataday ® TWICE DAILY RELIEF Eye Allergy Itch & Redness Relief Works in Minutes For Ages 2 and Older 30 DAY SUPPLY TAMPER EVIDENT: For your protection, this bottle has a seal imprinted with Alcon around the neck. ________Fill Line________ Do not use if seal is damaged or missing at time of purchase. ACTUAL SIZE Alcon Laboratories, Inc. 6201 South Freeway Fort Worth, Texas 76134 Country of Origin: Japan NDC: 0065-4274-01 300036779-0320 LOT: EXP.: Pataday ® TWICE DAILY RELIEF Olopatadine hydrochloride ophthalmic solution 0.1% Antihistamine and Redness Reliever Eye Allergy Itch & Redness Relief 5 mL (0.17 FL OZ) STERILE Only for use in the eye. Store between 4° – 25° C (39° – 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.: H15723-1219 Original Prescription Strength Pataday ® TWICE DAILY RELIEF Olopatadine hydrochloride ophthalmic solution 0.1% Antihistamine and Redness Reliever Eye Allergy Itch & Redness Relief TWICE DAILY #1 DOCTOR RECOMMENDED OTC EYE ALLERGY BRAND* Works in Minutes STERILE 5 mL (0.17 fl oz) Alcon LOT: EXP.: Pataday ® TWICE DAILY RELIEF Eye Allergy Itch & Redness Relief Works in Minutes For Ages 2 and Older 30 DAY SUPPLY TAMPER EVIDENT: For your protection, this bottle has a seal imprinted around the neck. ________Fill Line________ Do not use if seal is damaged or missing at time of purchase. ACTUAL SIZE *Based on a survey of eye care professionals, allergists, and primary care doctors. December 2024. Alcon Laboratories, Inc. 6201 South Freeway Fort Worth, Texas 76134 Country of Origin: Japan NDC: 0065-4274-01 300071456-0325 Pataday ® TWICE DAILY RELIEF Olopatadine hydrochloride ophthalmic solution 0.1% Antihistamine and Redness Reliever Eye Allergy Itch & Redness Relief 5 mL (0.17 fl oz) STERILE Only for use in the eye. Store between 4° – 25° C (39° – 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. 6201 South Freeway Fort Worth, TX 76134 LOT: EXP.: 300071824-0425", "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"}

Drug Facts

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information