ba550d08-a2de-45e7-b053-6bbecdff138b

SPL v1
SPL
SPL Set ID ba550d08-a2de-45e7-b053-6bbecdff138b
Route
ophthalmic
Published
Effective Date 2024-10-09
Document Type 34390-5 Human OTC Drug Label

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
anda active Since 2021-01-25
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°C to 25°C (36°F to 77°F)

Description

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

Principal Display Panel

Olopatadine Hydrochloride Ophthalmic Solution, USP 0.2% - Bottle Label - ALEMBIC 

 

Olopatadine Hydrochloride Ophthalmic Solution, USP 0.2% - Carton Label - ALEMBIC

Questions?

Contact Alembic Pharmaceuticals Inc. at 1-866-210-9797

Use(s)

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(s)

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

Inactive Ingredient Section

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

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°C to 25°C (36°F to 77°F)

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Olopatadine Hydrochloride Ophthalmic Solution, USP 0.2% - Bottle Label - ALEMBIC 

 

Olopatadine Hydrochloride Ophthalmic Solution, USP 0.2% - Carton Label - ALEMBIC

Questions? (QUESTIONS?)

Contact Alembic Pharmaceuticals Inc. at 1-866-210-9797

Use(s) (USE(S))

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(s) (ACTIVE INGREDIENT(S))

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

Inactive Ingredient Section (INACTIVE INGREDIENT SECTION)

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

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: 2026-02-15T12:03:44.365713 · Updated: 2026-03-14T23:03:57.888673