Drug Facts

Drug Facts
SPL v5
SPL
SPL Set ID 6d07a5d6-265c-4735-97b3-8a2575b276cb
Route
OPHTHALMIC
Published
Effective Date 2026-01-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Olopatadine (7 mg)
Inactive Ingredients
Benzalkonium Chloride Boric Acid Hydrochloric Acid Sodium Hydroxide Hydroxypropyl .gamma.-cyclodextrin Hypromellose, Unspecified Mannitol Polyethylene Glycol 400 Povidone, Unspecified Water

Identifiers & Packaging

Marketing Status
NDA Active Since 2020-09-01

Description

Active Ingredients Purpose Olopatadine (0.7%) (equivalent to olopatadine hydrochloride 0.776%) Antihistamine


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

Description

Active Ingredients Purpose Olopatadine (0.7%) (equivalent to olopatadine hydrochloride 0.776%) Antihistamine

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 (0.7%)

(equivalent to olopatadine hydrochloride 0.776%)
Antihistamine
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
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]

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

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 

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

EXTRA STRENGTH



Pataday ®



ONCE DAILY RELIEF




Olopatadine hydrochloride

ophthalmic solution 0.7%

Antihistamine



Eye Allergy Itch Relief



FULL 24 HOUR



#1 DOCTOR RECOMMENDED

OTC EYE ALLERGY

BRAND*




Works in Minutes



Alcon



STERILE

2.5 mL (0.085 fl oz) 



LOT:    EXP:



EXTRA STRENGTH



Pataday ®

ONCE DAILY RELIEF

Olopatadine hydrochloride

ophthalmic solution 0.7% Antihistamine

Eye Allergy Itch Relief



EXTRA STRENGTH



Pataday ®

ONCE DAILY RELIEF


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. 



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     300071514-0325



*Based on a survey of eye care professionals,

allergist, and primary care doctors. December 2024.

EXTRA STRENGTH



Pataday
®

ONCE DAILY RELIEF

Olopatadine hydrochloride 

ophthalmic solution 0.7% Antihistamine



EYE ALLERGY ITCH RELIEF



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 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.:



300071826

-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 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 (0.7%)

(equivalent to olopatadine hydrochloride 0.776%)
Antihistamine
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
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]

Other Information (Other information)
  • only for use in the eye
  • store between 2°-25°C (36°-77°F)
Inactive Ingredients (Inactive ingredients)

benzalkonium chloride 0.015%, boric acid, hydrochloric acid/sodium hydroxide (to adjust pH), hydroxypropylgamma- cyclodextrin, hypromellose, mannitol, polyethylene glycol 400, povidone, and purified water

Principal Display Panel (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 

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

EXTRA STRENGTH



Pataday ®



ONCE DAILY RELIEF




Olopatadine hydrochloride

ophthalmic solution 0.7%

Antihistamine



Eye Allergy Itch Relief



FULL 24 HOUR



#1 DOCTOR RECOMMENDED

OTC EYE ALLERGY

BRAND*




Works in Minutes



Alcon



STERILE

2.5 mL (0.085 fl oz) 



LOT:    EXP:



EXTRA STRENGTH



Pataday ®

ONCE DAILY RELIEF

Olopatadine hydrochloride

ophthalmic solution 0.7% Antihistamine

Eye Allergy Itch Relief



EXTRA STRENGTH



Pataday ®

ONCE DAILY RELIEF


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. 



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     300071514-0325



*Based on a survey of eye care professionals,

allergist, and primary care doctors. December 2024.

EXTRA STRENGTH



Pataday
®

ONCE DAILY RELIEF

Olopatadine hydrochloride 

ophthalmic solution 0.7% Antihistamine



EYE ALLERGY ITCH RELIEF



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 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.:



300071826

-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


Raw Label Data

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