Olopatadine Hydrochloride Ophthalmic Solution, Usp 0.2%

Olopatadine Hydrochloride Ophthalmic Solution, Usp 0.2%
SPL v1
SPL
SPL Set ID dbd28ee2-bbb5-a4b1-e053-2a95a90afff4
Route
OPHTHALMIC
Published
Effective Date 2022-04-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
ANDA Active Since 2022-04-08
Description

Active ingredient Olopatadine (0.2%) (equivalent to olopatadine hydrochloride, USP 0.222%)

Purpose

Antihistamine

Medication Information

Purpose

Antihistamine

Description

Active ingredient Olopatadine (0.2%) (equivalent to olopatadine hydrochloride, USP 0.222%)

Use

temporarily relieves itchy 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) once daily, no more than once 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
Drug Facts

Active ingredient



Olopatadine (0.2%)



(equivalent to olopatadine hydrochloride, USP 0.222%)

Questions?

✆1-855-274-4122



Manufactured by:



Eugia Pharma Specialities Limited, Unit III

IDA, Pashamylaram – 502307, TS., India.

Code: TS/DRUGS/13/2010

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

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

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 A Doctor If
  • 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 (1-800-222-1222) right away.

Package Label Principal Display Panel 0.2% (2.5 Ml Container)

NDC 68001-520-69

Olopatadine Hydrochloride



Ophthalmic Solution, USP



0.2%



Antihistamine



Eye Allergy Itch Relief



STERILE 2.5 mL (0.085 FL OZ)



Package Label Principal Display Panel 0.2% (2.5 Ml Container Carton)

NDC 68001-530-69





Olopatadine Hydrochloride



Ophthalmic Solution, USP



0.2%



Antihistamine



Eye Allergy Itch Relief





2.5 mL (0.085 FL OZ)



Structured Label Content

Use

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

Purpose

Antihistamine

Warnings

For external use only

Directions
  • adults and children 2 years of age and older:
    • put 1 drop in the affected eye(s) once daily, no more than once 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
Drug Facts

Active ingredient



Olopatadine (0.2%)



(equivalent to olopatadine hydrochloride, USP 0.222%)

Questions?

✆1-855-274-4122



Manufactured by:



Eugia Pharma Specialities Limited, Unit III

IDA, Pashamylaram – 502307, TS., India.

Code: TS/DRUGS/13/2010

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

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

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 A Doctor If (Stop use and ask a doctor if)
  • 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 (1-800-222-1222) right away.

Package Label Principal Display Panel 0.2% (2.5 Ml Container) (PACKAGE LABEL-PRINCIPAL DISPLAY PANEL-0.2% (2.5 mL Container))

NDC 68001-520-69

Olopatadine Hydrochloride



Ophthalmic Solution, USP



0.2%



Antihistamine



Eye Allergy Itch Relief



STERILE 2.5 mL (0.085 FL OZ)



Package Label Principal Display Panel 0.2% (2.5 Ml Container Carton) (PACKAGE LABEL-PRINCIPAL DISPLAY PANEL-0.2% (2.5 mL Container Carton))

NDC 68001-530-69





Olopatadine Hydrochloride



Ophthalmic Solution, USP



0.2%



Antihistamine



Eye Allergy Itch Relief





2.5 mL (0.085 FL OZ)



Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:00:11.311421 · Updated: 2026-03-14T23:00:32.199749