Drug Facts

Drug Facts
SPL v4
SPL
SPL Set ID 616da51c-70f4-3f87-320f-4685ad1520fa
Route
OPHTHALMIC
Published
Effective Date 2024-09-27
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 Sodium Chloride Hydrochloric Acid Sodium Hydroxide Water

Identifiers & Packaging

Marketing Status
ANDA Active Since 2022-10-06

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%)                                  

Uses

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

Warnings

For external use only

Directions

  • adults and children 2 years 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?

1-800-706-5575

Active Ingredient

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

                                 

Other Information

  • Only for use in the eye
  • Store between 2ºC to 25ºC (36ºF to 77ºF)
Inactive Ingredients

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

Principal Display Panel

ONCE DAILY RELIEF

Olopatadine HCl Ophthalmic Solution, USP 0.2%

Antihistamine

Eye Allergy Itch Relief

NDC 60505-6222-2

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 right away.  


Structured Label Content

Uses

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 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?

1-800-706-5575

Active Ingredient (Active ingredient)

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

                                 

Other Information (Other information)

  • Only for use in the eye
  • Store between 2ºC to 25ºC (36ºF to 77ºF)
Inactive Ingredients (Inactive ingredients)

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

Principal Display Panel

ONCE DAILY RELIEF

Olopatadine HCl Ophthalmic Solution, USP 0.2%

Antihistamine

Eye Allergy Itch Relief

NDC 60505-6222-2

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 right away.  


Advanced Ingredient Data


Raw Label Data

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