SPL v2
SPL
SPL Set ID 75823e5d-562a-43c2-8365-6f3f9484c9bf
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
Description

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

Purpose

Antihistamine

Medication Information

Purpose

Antihistamine

Description

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

Use(s)

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
Questions?

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

Other Information

• only for use in the eye

• store between 2°C to 25°C (36°F to 77°F)

Active Ingredient(s)

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



Principal Display Panel

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

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

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

 

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

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

Use(s) (USE(S))

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

Purpose (PURPOSE)

Antihistamine

Warnings (WARNINGS)

For external use only

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

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
Questions? (QUESTIONS?)

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

Other Information (OTHER INFORMATION)

• only for use in the eye

• store between 2°C to 25°C (36°F to 77°F)

Active Ingredient(s) (ACTIVE INGREDIENT(S))

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



Principal Display Panel (PRINCIPAL DISPLAY PANEL)

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

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

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

 

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

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: 2026-02-15T12:03:44.346331 · Updated: 2026-03-14T23:03:57.888673