ad35e069-72ba-b8df-d6bd-18c0345c80ac

SPL v2
SPL
SPL Set ID ad35e069-72ba-b8df-d6bd-18c0345c80ac
Route
ophthalmic
Published
Effective Date 2020-05-25
Document Type 34390-5 Human OTC Drug Label

Drug Facts

Composition & Product

Active Ingredients
olopatadine (2 mg)
Inactive Ingredients
benzalkonium chloride sodium phosphate, dibasic, anhydrous edetate disodium hydrochloric acid povidone k30 sodium chloride sodium hydroxide water

Identifiers & Packaging

Marketing Status
anda active Since 2021-03-15
Purpose

Antihistamine

Description

Olopatadine (0.2%)  (equivalent to olopatadine hydrochloride 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

Olopatadine (0.2%)  (equivalent to olopatadine hydrochloride 0.222%)

Principal Display Panel



Olopatadine Hydrochloride

Ophthalmic Solution, USP

0.2%



Questions?

Call 833-358-6431 Monday to Friday 9:00am to 7:00pm EST

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
Active Ingredient

Olopatadine (0.2%)  (equivalent to olopatadine hydrochloride 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 Doctor If

you experience:  

  • 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 right away.

Structured Label Content

Warnings (WARNINGS)

For external use only

Purpose (PURPOSE)

Antihistamine

Directions (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.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)



Olopatadine Hydrochloride

Ophthalmic Solution, USP

0.2%



Questions? (QUESTIONS?)

Call 833-358-6431 Monday to Friday 9:00am to 7:00pm EST

Use (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
Active Ingredient (ACTIVE INGREDIENT)

Olopatadine (0.2%)  (equivalent to olopatadine hydrochloride 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 Doctor If (STOP USE AND ASK DOCTOR IF)

you experience:  

  • 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 right away.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:39.711889 · Updated: 2026-03-14T23:11:22.461750