DailyMed - DailyMed Details

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 2021-05-06

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?

✆1-855-274-4122

Distributed by:

FOODHOLD U.S.A., LLC,

LANDOVER, MD 20785

MADE IN INDIA

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)

CAREOne NDC 72476-852-64

EYE ALLERGY ITCH

& REDNESS RELIEF

Olopatadine Hydrochloride

Ophthalmic Solution USP, 0.1%

Antihistamine and Redness Reliever

STERILE 5 mL (0.17 FL OZ)

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

CAREOne          NDC 72476-852-64

Compare to the Active Ingredient in

Pataday^® Twice Daily Relief^®

EYE ALLERGY ITCH

& REDNESS RELIEF

Olopatadine Hydrochloride

Ophthalmic Solution USP, 0.1%

TWICE DAILY

Now available without a prescription

Antihistamine and Redness Reliver

Works in Minutes

Relief from Allergens:

Pet Dander, Pollen, Grass, Ragweed

                                         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?

✆1-855-274-4122

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 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))

CAREOne NDC 72476-852-64

EYE ALLERGY ITCH

& REDNESS RELIEF

Olopatadine Hydrochloride

Ophthalmic Solution USP, 0.1%

Antihistamine and Redness Reliever

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))

CAREOne          NDC 72476-852-64

Compare to the Active Ingredient in

Pataday^® Twice Daily Relief^®

EYE ALLERGY ITCH

& REDNESS RELIEF

Olopatadine Hydrochloride

Ophthalmic Solution USP, 0.1%

TWICE DAILY

Now available without a prescription

Antihistamine and Redness Reliver

Works in Minutes

Relief from Allergens:

Pet Dander, Pollen, Grass, Ragweed

                                         STERILE

                                          5 mL (0.17 FL OZ)

Advanced Ingredient Data

[{"name": "OLOPATADINE", "unii": "D27V6190PM", "classCode": "ACTIB", "strengthNumerator": "1", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "BENZALKONIUM CHLORIDE", "unii": "F5UM2KM3W7", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM", "unii": "GR686LBA74", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM CHLORIDE", "unii": "451W47IQ8X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYDROCHLORIC ACID", "unii": "QTT17582CB", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM HYDROXIDE", "unii": "55X04QC32I", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"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": "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?": "✆1-855-274-4122 Distributed by: FOODHOLD U.S.A., LLC, LANDOVER, MD 20785 MADE IN INDIA", "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)": "CAREOne NDC 72476-852-64 EYE ALLERGY ITCH & REDNESS RELIEF Olopatadine Hydrochloride Ophthalmic Solution USP, 0.1% Antihistamine and Redness Reliever STERILE 5 mL (0.17 FL OZ)", "PACKAGE LABEL-PRINCIPAL DISPLAY PANEL-0.1% (5 mL Container Carton)": "CAREOne NDC 72476-852-64 Compare to the Active Ingredient in Pataday ® Twice Daily Relief ® EYE ALLERGY ITCH & REDNESS RELIEF Olopatadine Hydrochloride Ophthalmic Solution USP, 0.1% TWICE DAILY Now available without a prescription Antihistamine and Redness Reliver Works in Minutes Relief from Allergens: Pet Dander, Pollen, Grass, Ragweed STERILE 5 mL (0.17 FL OZ)"}