Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID 07e8b359-d4ae-4b5b-81dc-c7e57e172c58
Route
OPHTHALMIC
Published
Effective Date 2026-01-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Olopatadine (2 mg)
Inactive Ingredients
Benzalkonium Chloride Edetate Disodium Hydrochloric Acid Povidone K30 Sodium Chloride Sodium Hydroxide Sodium Phosphate, Dibasic, Anhydrous Water

Identifiers & Packaging

Marketing Status
ANDA Active Since 2025-02-28
Description

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

(equivalent to olopatadine hydrochloride 0.222%)

Antihistamine
Directions
  • •
    adults and children 2 years of age and older:
    • o
      put 1 drop in the affected eye(s) once daily, no more than once per day
    • o
      if using other ophthalmic products while using this product, wait at least 5 minutes between each product

    • o
      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 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

07/2025

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

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

Principal Display Panel

NDC 72657-194-25

Olopatadine HCl Ophthalmic Solution 0.2% 

Antihistamine

Once Daily

STERILE

2.5 mL (0.085 FL OZ)

NDC: 72657-194-25

Original Prescription Strength



ONCE DAILY



Olopatadine HCl Ophthalmic Solution, USP 0.2%

Antihistamine

Eye Allergy Itch Relief

STERILE

2.5 mL (0.085 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)

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 0.2%

(equivalent to olopatadine hydrochloride 0.222%)

Antihistamine
Directions
  • •
    adults and children 2 years of age and older:
    • o
      put 1 drop in the affected eye(s) once daily, no more than once per day
    • o
      if using other ophthalmic products while using this product, wait at least 5 minutes between each product

    • o
      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?

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

07/2025

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

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

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NDC 72657-194-25

Olopatadine HCl Ophthalmic Solution 0.2% 

Antihistamine

Once Daily

STERILE

2.5 mL (0.085 FL OZ)

NDC: 72657-194-25

Original Prescription Strength



ONCE DAILY



Olopatadine HCl Ophthalmic Solution, USP 0.2%

Antihistamine

Eye Allergy Itch Relief

STERILE

2.5 mL (0.085 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

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Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:08:22.012156 · Updated: 2026-03-14T23:12:35.594126