SPL v5
SPL
SPL Set ID 067baa0b-5c01-4908-92de-ad79c73d2c37
Route
OPHTHALMIC
Published
Effective Date 2023-07-10
Document Type 34390-5 Human OTC Drug Label

Drug Facts

Composition & Product

Active Ingredients
Olopatadine (2 mg)
Inactive Ingredients
Benzalkonium Chloride Sodium Phosphate, Dibasic, Unspecified Form Edetate Disodium Hydrochloric Acid Sodium Hydroxide Povidone, Unspecified Sodium Chloride Water

Identifiers & Packaging

Marketing Status
ANDA Active Since 2021-01-19

Description

Active ingredient Olopatadine (0.2%) (equivalent to olopatadine hydrochloride, USP 0.222%)

Purpose

Antihistamine


Medication Information

Purpose

Antihistamine

Description

Active ingredient Olopatadine (0.2%) (equivalent to olopatadine hydrochloride, USP 0.222%)

Use

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
Drug Facts

Active ingredient

Olopatadine (0.2%)

(equivalent to olopatadine hydrochloride, USP 0.222%)

Questions?

✆1-855-274-4122



Distributed By

AmerisourceBergen

1 West First Avenue

Conshohocken, PA 1942



Made in India

Code: TS/DRUGS/13/2010

Other Information
  • only for use in the eye
  • store between 2° to 25°C (36° to 77°F)
Inactive Ingredients

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

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
Package Label Principal Display Panel 0.2% (2.5 Ml Container)

GOOD

NEIGHBOR

PHARMACY®                             NDC 46122-671-27

Olopatadine Hydrochloride

Ophthalmic Solution USP, 0.2%

Antihistamine

                                                     Eye Allergy Relief

STERILE                             2.5 mL (0.085 FL OZ)

Package Label Principal Display Panel 0.2% (2.5 Ml Container Carton)

                                                  *Compare to the Active Ingredient

                                                         in Pataday® Once Daily Relief

GOOD

NEIGHBOR

PHARMACY®                             NDC 46122-671-27

NOW AVAILABLE without a prescription

Olopatadine Hydrochloride

Ophthalmic Solution, USP

0.2%

Antihistamine

                                      Eye Allergy Relief

Works in Minutes

Relief from Allergens:

• Pet Dander • Pollen                     ONCE

• Grass • Ragweed                          DAILY

STERILE

2.5 mL (0.085 FL OZ)


Structured Label Content

Use

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
Drug Facts

Active ingredient

Olopatadine (0.2%)

(equivalent to olopatadine hydrochloride, USP 0.222%)

Questions?

✆1-855-274-4122



Distributed By

AmerisourceBergen

1 West First Avenue

Conshohocken, PA 1942



Made in India

Code: TS/DRUGS/13/2010

Other Information (Other information)
  • only for use in the eye
  • store between 2° to 25°C (36° to 77°F)
Inactive Ingredients (Inactive ingredients)

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

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
Package Label Principal Display Panel 0.2% (2.5 Ml Container) (PACKAGE LABEL-PRINCIPAL DISPLAY PANEL-0.2% (2.5 mL Container))

GOOD

NEIGHBOR

PHARMACY®                             NDC 46122-671-27

Olopatadine Hydrochloride

Ophthalmic Solution USP, 0.2%

Antihistamine

                                                     Eye Allergy Relief

STERILE                             2.5 mL (0.085 FL OZ)

Package Label Principal Display Panel 0.2% (2.5 Ml Container Carton) (PACKAGE LABEL-PRINCIPAL DISPLAY PANEL-0.2% (2.5 mL Container Carton))

                                                  *Compare to the Active Ingredient

                                                         in Pataday® Once Daily Relief

GOOD

NEIGHBOR

PHARMACY®                             NDC 46122-671-27

NOW AVAILABLE without a prescription

Olopatadine Hydrochloride

Ophthalmic Solution, USP

0.2%

Antihistamine

                                      Eye Allergy Relief

Works in Minutes

Relief from Allergens:

• Pet Dander • Pollen                     ONCE

• Grass • Ragweed                          DAILY

STERILE

2.5 mL (0.085 FL OZ)


Advanced Ingredient Data


Raw Label Data

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