SPL v6
SPL
SPL Set ID 5255d142-7d04-ab80-fa97-b11c4486e42c
Route
OPHTHALMIC
Published
Effective Date 2020-06-17
Document Type 34390-5 Human OTC Drug Label

Drug Facts

Composition & Product

Active Ingredients
Olopatadine (1 mg)
Inactive Ingredients
Benzalkonium Chloride Sodium Phosphate, Dibasic Hydrochloric Acid Sodium Chloride Sodium Hydroxide Water

Identifiers & Packaging

Marketing Status
ANDA Active Since 2021-01-15

Description

Olopatadine (0.1%) (equivalent to olopatadine hydrochloride 0.111%)

Purpose

Antihistamine and redness reliever


Medication Information

Purpose

Antihistamine and redness reliever



Description

Olopatadine (0.1%) (equivalent to olopatadine hydrochloride 0.111%)

Uses

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

Warnings

For external use only

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?

Call 1-888-375-3784

Active Ingredient

Olopatadine (0.1%) (equivalent to olopatadine hydrochloride 0.111%)

Other Information

• only for use in the eye  

• store between 4° to 25°C (39° to 77°F)

Inactive Ingredients

Benzalkonium chloride 0.01%, Dibasic sodium phosphate, Hydrochloric acid and /or Sodium hydroxide (to adjust pH), Sodium chloride and Water for Injection.

Principal Display Panel

Olopatadine Hydrochloride Ophthalmic Solution USP, 0.1%

NOW AVAILABLE Without a Prescription

Eye Allergy Itch & Redness Relief

Olopatadine HCl

Ophthalmic solution USP, 0.1%

Antihistamine and Redness Reliever

Twice Daily Relief

Works in Minutes

Relief from Allergens:

• Pet Dander • Pollen • Grass • Ragweed

Twice Daily

Sterile

5 mL (0.17 FL OZ)

For Ages 2 and Older

30 DAY SUPPLY

Packaged with Tamper-Evident bottle cap. Do Not Use if breakable ring is separated or missing.

COMPARE TO PATADAY® active ingredient*

©2020 CARDINAL HEALTH, LEADER, and LOGOs are trademarks of Cardinal Health. All other marks are the property of their respective owners.

DISTRIBUTED BY CARDINAL HEALTH

DUBLIN, OHIO 43017

www.myleader.com 1-800-200-6313

Made in India

Code: AP/DRUGS/103/97

CIN 5659230 REV. 9/20

*This product is not manufactured or distributed by Alcon Laboratories Inc., distributor of Pataday®. Pataday® is a registered trademark of Novartis AG.

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


Stop Use and Ask Doctor If

you experience:  

  • eye pain
  • changes in vision
  • increased redness of the eye
  • itching worsens or lasts for more than 72 hours
Keep Out of Reach of Children

If swallowed, get medical help or contact a Poison Control Center right away.


Structured Label Content

Uses (USES)

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

Purpose (PURPOSE)

Antihistamine and redness reliever



Warnings (WARNINGS)

For external use only

Directions (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? (QUESTIONS?)

Call 1-888-375-3784

Active Ingredient (ACTIVE INGREDIENT)

Olopatadine (0.1%) (equivalent to olopatadine hydrochloride 0.111%)

Other Information (OTHER INFORMATION)

• only for use in the eye  

• store between 4° to 25°C (39° to 77°F)

Inactive Ingredients (INACTIVE INGREDIENTS)

Benzalkonium chloride 0.01%, Dibasic sodium phosphate, Hydrochloric acid and /or Sodium hydroxide (to adjust pH), Sodium chloride and Water for Injection.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Olopatadine Hydrochloride Ophthalmic Solution USP, 0.1%

NOW AVAILABLE Without a Prescription

Eye Allergy Itch & Redness Relief

Olopatadine HCl

Ophthalmic solution USP, 0.1%

Antihistamine and Redness Reliever

Twice Daily Relief

Works in Minutes

Relief from Allergens:

• Pet Dander • Pollen • Grass • Ragweed

Twice Daily

Sterile

5 mL (0.17 FL OZ)

For Ages 2 and Older

30 DAY SUPPLY

Packaged with Tamper-Evident bottle cap. Do Not Use if breakable ring is separated or missing.

COMPARE TO PATADAY® active ingredient*

©2020 CARDINAL HEALTH, LEADER, and LOGOs are trademarks of Cardinal Health. All other marks are the property of their respective owners.

DISTRIBUTED BY CARDINAL HEALTH

DUBLIN, OHIO 43017

www.myleader.com 1-800-200-6313

Made in India

Code: AP/DRUGS/103/97

CIN 5659230 REV. 9/20

*This product is not manufactured or distributed by Alcon Laboratories Inc., distributor of Pataday®. Pataday® is a registered trademark of Novartis AG.

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


Stop Use and Ask Doctor If (STOP USE AND ASK DOCTOR IF)

you experience:  

  • eye pain
  • changes in vision
  • increased redness of the eye
  • itching worsens or lasts for more than 72 hours
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.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)