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
Purpose

Antihistamine

Description

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

Medication Information

Warnings

For external use only

Purpose

Antihistamine

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
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

Description

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

Use

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

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%)

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

Warnings

For external use only

Purpose

Antihistamine

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
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

Questions?

✆1-855-274-4122



Manufactured by:



Eugia Pharma Specialities Limited, Unit III

IDA, Pashamylaram – 502307, TS., India.

Code: TS/DRUGS/13/2010

Use

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

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%)

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)



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