SPL v4
SPL
SPL Set ID 06467360-22fe-4a48-b234-06dbff30e853
Route
OPHTHALMIC
Published
Effective Date 2022-02-21
Document Type 34390-5 Human OTC Drug Label

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
ANDA Active Since 2020-07-15
Description

Active ingredient Olopatadine (0.1%). (equivalent to olopatadine hydrochloride, USP 0.111%)

Purpose

Antihistamine and Redness Reliever

Medication Information

Purpose

Antihistamine and Redness Reliever

Description

Active ingredient Olopatadine (0.1%). (equivalent to olopatadine hydrochloride, USP 0.111%)

Uses

temporarily relieves itchy and red 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) 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
Drug Facts

Active ingredient

 Olopatadine (0.1%).

(equivalent to olopatadine hydrochloride, USP 0.111%)

Questions?

✆1-888-287-1915

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

benzalkonium chloride 0.01%, dibasic sodium phosphate, hydrochloric acid/sodium hydroxide (adjust pH), 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
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 (1-800-222-1222) right away.

Package Label Principal Display Panel 0.1% (5 Ml Container)

                             NDC 79903-000-40

 equateTM

Olopatadine Hydrochloride

 Ophthalmic Solution USP, 0.1%

 Antihistamine and Redness Reliever

 EYE ALLERGY ITCH & REDNESS RELIEF

Sterile                    5 mL (0.17 FL OZ)

Package Label Principal Display Panel 0.1% (5 Ml Container Carton)

                                                      NDC 79903-000-40

 equateTM

Compare to Pataday® Twice Daily Relief active ingredient*

NOW AVAILABLE

 WITHOUT A PRESCRIPTION

 Olopatadine

 Hydrochloride

 Ophthalmic Solution

 USP, 0.1%

Antihistamine and

Redness Reliever

EYE ALLERGY ITCH & REDNESS RELIEF

 Works in Minutes

 Relief from Allergens:

 • Pet Dander • Pollen

 • Grass • Ragweed

 TWICE DAILY

 STERILE

 5 mL (0.17 FL OZ)

Structured Label Content

Uses

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

Purpose

Antihistamine and Redness Reliever

Warnings

For external use only

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
Drug Facts

Active ingredient

 Olopatadine (0.1%).

(equivalent to olopatadine hydrochloride, USP 0.111%)

Questions?

✆1-888-287-1915

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

benzalkonium chloride 0.01%, dibasic sodium phosphate, hydrochloric acid/sodium hydroxide (adjust pH), 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
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.

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Package Label Principal Display Panel 0.1% (5 Ml Container) (PACKAGE LABEL-PRINCIPAL DISPLAY PANEL-0.1% (5 mL Container))

                             NDC 79903-000-40

 equateTM

Olopatadine Hydrochloride

 Ophthalmic Solution USP, 0.1%

 Antihistamine and Redness Reliever

 EYE ALLERGY ITCH & REDNESS RELIEF

Sterile                    5 mL (0.17 FL OZ)

Package Label Principal Display Panel 0.1% (5 Ml Container Carton) (PACKAGE LABEL-PRINCIPAL DISPLAY PANEL-0.1% (5 mL Container Carton))

                                                      NDC 79903-000-40

 equateTM

Compare to Pataday® Twice Daily Relief active ingredient*

NOW AVAILABLE

 WITHOUT A PRESCRIPTION

 Olopatadine

 Hydrochloride

 Ophthalmic Solution

 USP, 0.1%

Antihistamine and

Redness Reliever

EYE ALLERGY ITCH & REDNESS RELIEF

 Works in Minutes

 Relief from Allergens:

 • Pet Dander • Pollen

 • Grass • Ragweed

 TWICE DAILY

 STERILE

 5 mL (0.17 FL OZ)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:00:14.674714 · Updated: 2026-03-14T23:00:37.728626