Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID a80c3fd2-47b7-4ed0-b862-9c5099684607
Route
OPHTHALMIC
Published
Effective Date 2026-01-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
ANDA Active Since 2024-07-26

Description

Active Ingredient Purpose Olopatadine (0.1%). (equivalent to olopatadine hydrochloride 0.111%) Antihistamine and redness reliever


Medication Information

Warnings and Precautions

Warnings

For external use only

Indications and Usage

Uses

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

Description

Active Ingredient 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 Ingredient

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

Other Information
  • only for use in the eye
  • store between 4°C to 25°C (39°F 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.

Questions Or Comments?

Call weekdays 9 AM to 6 PM EST at 1 (888) 721-7115.

Distributed by:

Glenmark Therapeutics Inc., USA

Elmwood Park, NJ 07407

Product of Spain

07/25

Principal Display Panel

NDC 72657-168-50

Olopatadine HCl Ophthalmic Solution, USP 0.1%



Antihistamine and Redness Reliever

Twice Daily Relief

Eye Allergy Itch & Redness Relief

STERILE

5 mL (0.17 FL OZ)





NDC 72657-168-50

Olopatadine HCl Ophthalmic Solution,USP 0.1%



Antihistamine and Redness Reliever

Twice Daily



STERILE

5 mL (0.17 FL OZ)



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)

Uses

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 Ingredient

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

Other Information (Other information)
  • only for use in the eye
  • store between 4°C to 25°C (39°F 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.

Questions Or Comments? (Questions or comments?)

Call weekdays 9 AM to 6 PM EST at 1 (888) 721-7115.

Distributed by:

Glenmark Therapeutics Inc., USA

Elmwood Park, NJ 07407

Product of Spain

07/25

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NDC 72657-168-50

Olopatadine HCl Ophthalmic Solution, USP 0.1%



Antihistamine and Redness Reliever

Twice Daily Relief

Eye Allergy Itch & Redness Relief

STERILE

5 mL (0.17 FL OZ)





NDC 72657-168-50

Olopatadine HCl Ophthalmic Solution,USP 0.1%



Antihistamine and Redness Reliever

Twice Daily



STERILE

5 mL (0.17 FL OZ)



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

All Sections (JSON)