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

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
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

Description

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

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)

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

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
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

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

Warnings and Precautions (34071-1)

Warnings

For external use only

Indications and Usage (34067-9)

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

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
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)

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

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
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

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)

Additional Information

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