SPL v2
SPL
SPL Set ID bca27f6a-d1b1-1d6a-e053-2995a90a37b5
Route
OPHTHALMIC
Published
Effective Date 2021-04-01
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 2021-04-02
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?

✆ 1-866-850-2876



DISTRIBUTED BY:

FOODHOLD U.S.A., LLC,

LANDOVER, MD 20785

MADE IN INDIA

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)

CAREone        NDC 72476-851-21

EYE ALLERGY ITCH RELIEF

Olopatadine Hydrochloride

Ophthalmic Solution USP, 0.2%

Antihistamine

STERILE           2.5 mL (0.085 FL OZ)



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

                                         NDC 72476-851-21

CAREone

 Compare to the Active Ingredient in

Pataday® Once Daily Relief



 EYE ALLERGY

ITCH RELIEF

Olopatadine Hydrochloride

Ophthalmic Solution USP, 0.2%



ONCE DAILY

Now available without a prescription

Antihistamine

Works in Minutes

Relief from Allergens:

Pet Dander, Pollen, Grass, Ragweed



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?

✆ 1-866-850-2876



DISTRIBUTED BY:

FOODHOLD U.S.A., LLC,

LANDOVER, MD 20785

MADE IN INDIA

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))

CAREone        NDC 72476-851-21

EYE ALLERGY ITCH RELIEF

Olopatadine Hydrochloride

Ophthalmic Solution USP, 0.2%

Antihistamine

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))

                                         NDC 72476-851-21

CAREone

 Compare to the Active Ingredient in

Pataday® Once Daily Relief



 EYE ALLERGY

ITCH RELIEF

Olopatadine Hydrochloride

Ophthalmic Solution USP, 0.2%



ONCE DAILY

Now available without a prescription

Antihistamine

Works in Minutes

Relief from Allergens:

Pet Dander, Pollen, Grass, Ragweed



STERILE

2.5 mL (0.085 FL OZ)



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Raw Label Data

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Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:59:29.196546 · Updated: 2026-03-14T22:59:29.411693