Drug Facts

Drug Facts
SPL v4
SPL
SPL Set ID 9e4c86f3-e674-4727-a136-6735591ef816
Route
OPHTHALMIC
Published
Effective Date 2024-11-01
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 2025-01-20

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 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?

Call 1-800-553-5340

Active Ingredient

Olopatadine (0.2%)

(equivalent to olopatadine hydrochloride 0.222%)

Other Information
  • only for use in the eye
  • store between 4 25 °C (39 77 °F)
  • protect from light
Inactive Ingredients

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

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
Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Package/label Principal Display Panel

Compare to the active ingredient in

Pataday Once Daily Relief*

BAUSCH + LOMB

NDC 24208-617-01

Olopatadine

Hydrochloride

Ophthalmic

Solution USP, 0.2%

Antihistamine

Eye Allergy Itch Relief



ONCE DAILY



Works in Minutes

Relief from Allergens:

• Pet Dander • Pollen

• Grass • Ragweed

STERILE

3.5 ml (0.12 FL OZ)

ORIGINAL

PRESCRIPTION

STRENGTH

3912400

AB61705

*This product is not manufactured or distributed by

Alcon owner of the trademark Pataday.

Stop Use and Ask A Doctor If You Experience:
  • eye pain
  • changes in vision
  • increased redness of the eye
  • itching worsens or lasts for more than 72 hours

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 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?

Call 1-800-553-5340

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 4 25 °C (39 77 °F)
  • protect from light
Inactive Ingredients (Inactive ingredients)

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

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
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.

Package/label Principal Display Panel (Package/Label Principal Display Panel)

Compare to the active ingredient in

Pataday Once Daily Relief*

BAUSCH + LOMB

NDC 24208-617-01

Olopatadine

Hydrochloride

Ophthalmic

Solution USP, 0.2%

Antihistamine

Eye Allergy Itch Relief



ONCE DAILY



Works in Minutes

Relief from Allergens:

• Pet Dander • Pollen

• Grass • Ragweed

STERILE

3.5 ml (0.12 FL OZ)

ORIGINAL

PRESCRIPTION

STRENGTH

3912400

AB61705

*This product is not manufactured or distributed by

Alcon owner of the trademark Pataday.

Stop Use and Ask A Doctor If You Experience: (Stop use and ask a doctor if you experience:)
  • eye pain
  • changes in vision
  • increased redness of the eye
  • itching worsens or lasts for more than 72 hours

Advanced Ingredient Data


Raw Label Data

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