Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 05ab7b8d-c828-4246-b809-1eb3e4b4129f
Route
OPHTHALMIC
Published
Effective Date 2025-02-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Olopatadine (1 mg)
Inactive Ingredients
Benzalkonium Chloride Hydrochloric Acid Sodium Chloride Sodium Hydroxide Sodium Phosphate, Dibasic, Anhydrous Water

Identifiers & Packaging

Marketing Status
ANDA Active Since 2025-03-01
Description

Active Ingredient Purpose Olopatadine (0.1%). (equivalent to olopatadine hydrochloride 0.111%) Antihistamine and redness reliever

Medication Information

Warnings and Precautions

Warnings

For external use only

Indications and Usage

Uses

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

Description

Active Ingredient Purpose Olopatadine (0.1%). (equivalent to olopatadine hydrochloride 0.111%) Antihistamine and redness reliever

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

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

Section 55105-1

Active Ingredient

Purpose

Olopatadine (0.1%).

(equivalent to olopatadine hydrochloride 0.111%)

Antihistamine and redness reliever
Directions
  • •
    adults and children 2 years of age and older:
  • •
    put 1 drop in the affected eye(s) twice daily, every 6 to 8 hours, no more than twice 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

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

benzalkonium chloride 0.01%, dibasic sodium phosphate, hydrochloric acid and/ or sodium hydroxide (to adjust PH), sodium chloride and water for injection.

Questions Or Comments?

In the U.S., call Monday to Friday 9:00am to 7:00pm EST.at (833) 358-6431.

Distributed by:

McKesson Corp.,

Via Strategic Sourcing Services LLC.

Memphis, TN 38141

Product of Spain

February 2025

Principal Display Panel

NDC 70677-1280-1

Olopatadine hydrochloride ophthalmic solution 0.1%



Antihistamine and Redness Reliever

Twice Daily Relief

Eye Allergy Itch & Redness Relief

5 mL

STERILE



NDC 70677-1280-1

Olopatadine hydrochloride ophthalmic solution 0.1%



Antihistamine and Redness Reliever

Twice Daily Relief

Eye Allergy Itch & Redness Relief





5 mL

STERILE



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

Structured Label Content

Indications and Usage (34067-9)

Uses

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

Warnings and Precautions (34071-1)

Warnings

For external use only

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

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

Section 55105-1 (55105-1)

Active Ingredient

Purpose

Olopatadine (0.1%).

(equivalent to olopatadine hydrochloride 0.111%)

Antihistamine and redness reliever
Directions
  • •
    adults and children 2 years of age and older:
  • •
    put 1 drop in the affected eye(s) twice daily, every 6 to 8 hours, no more than twice 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

Other Information (Other information)
  • •
    only for use in the eye
  • •
    store between 4°C to 25°C (39°F to 77°F)
Inactive Ingredients (Inactive ingredients)

benzalkonium chloride 0.01%, dibasic sodium phosphate, hydrochloric acid and/ or sodium hydroxide (to adjust PH), sodium chloride and water for injection.

Questions Or Comments? (Questions or comments?)

In the U.S., call Monday to Friday 9:00am to 7:00pm EST.at (833) 358-6431.

Distributed by:

McKesson Corp.,

Via Strategic Sourcing Services LLC.

Memphis, TN 38141

Product of Spain

February 2025

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NDC 70677-1280-1

Olopatadine hydrochloride ophthalmic solution 0.1%



Antihistamine and Redness Reliever

Twice Daily Relief

Eye Allergy Itch & Redness Relief

5 mL

STERILE



NDC 70677-1280-1

Olopatadine hydrochloride ophthalmic solution 0.1%



Antihistamine and Redness Reliever

Twice Daily Relief

Eye Allergy Itch & Redness Relief





5 mL

STERILE



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

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:38.263016 · Updated: 2026-03-14T23:07:45.169331