1ce2f408-6eff-ca83-e063-6394a90a6d1a

SPL v2
SPL
SPL Set ID 1ce2f408-6eff-ca83-e063-6394a90a6d1a
Route
ophthalmic
Published
Effective Date 2024-10-22
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 2020-07-15

Purpose

Antihistamine

Description

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


Medication Information

Warnings

For external use only

Purpose

Antihistamine

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
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

Description

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

Questions?

✆ 1-855-274-4122





DISTRIBUTED BY:

RITE AID,

200 NEWBERRY COMMONS

ETTERS, PA 17319

www.riteaid.com

MADE IN INDIA

Use

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

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%)

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)


                               NDC 11822-0063-2

EYE ALLERGY                            ONCE DAILY

ITCH RELIEF             


OLOPATADINE HYDROCHLORIDE

OPHTHALMIC SOLUTION

USP, 0.2%


Antihistamine                                    2.5 mL

STERILE                               (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*

                             NDC 11822-0063-2

ONCE DAILY RELIEF

EYE ALLERGY

ITCH RELIEF

OLOPATADINE

HYDROCHLORIDE

OPHTHALMIC

SOLUTION USP, 0.2%


Antihistamine

Works in Minutes

Relief from Allergens:

• Pet Dander • Pollen

• Grass • Ragweed

                                        STERILE

ONCE DAILY

Now available

without a                                   2.5 mL

prescription                   (0.085 FL OZ)


Structured Label Content

Warnings

For external use only

Purpose

Antihistamine

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
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

Questions?

✆ 1-855-274-4122





DISTRIBUTED BY:

RITE AID,

200 NEWBERRY COMMONS

ETTERS, PA 17319

www.riteaid.com

MADE IN INDIA

Use

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

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%)

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))


                               NDC 11822-0063-2

EYE ALLERGY                            ONCE DAILY

ITCH RELIEF             


OLOPATADINE HYDROCHLORIDE

OPHTHALMIC SOLUTION

USP, 0.2%


Antihistamine                                    2.5 mL

STERILE                               (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*

                             NDC 11822-0063-2

ONCE DAILY RELIEF

EYE ALLERGY

ITCH RELIEF

OLOPATADINE

HYDROCHLORIDE

OPHTHALMIC

SOLUTION USP, 0.2%


Antihistamine

Works in Minutes

Relief from Allergens:

• Pet Dander • Pollen

• Grass • Ragweed

                                        STERILE

ONCE DAILY

Now available

without a                                   2.5 mL

prescription                   (0.085 FL OZ)


Advanced Ingredient Data


Raw Label Data

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