DailyMed - DailyMed Details

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

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:

Aurohealth LLC

279 Princeton-Hightstown Road

East Windsor, NJ 08520

Made in India

Other Information

only for use in the eye
store between 2° to 25°C (39° 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

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

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 0.2% (2.5 Ml Container)

AUROHEALTH NDC 58602-007-39

Olopatadine Hydrochloride

Ophthalmic Solution, USP

0.2%

Antihistamine

Eye Allergy Itch Relief

STERILE 2.5 mL (0.085 FL OZ)

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

AUROHEALTH             NDC 58602-007-39

                 *Compare to the Active Ingredient in

                        Pataday^® Once Daily Relief

NOW AVAILABLE without a prescription

Olopatadine Hydrochloride

Ophthalmic Solution, USP

0.2%

Antihistamine

Eye Allergy Itch Relief

Works in Minutes

Relief from Allergens:                    ONCE

• Pet Dander • Pollen                   DAILY

• Grass • Ragweed                      STERILE

                                 2.5 mL (0.085 FL OZ)

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

Twin Pack

AUROHEALTH             NDC 58602-007-41

                *Compare to the Active Ingredient in

                            Pataday^® Once Daily Relief

NOW AVAILABLE without a prescription

Olopatadine Hydrochloride

Ophthalmic Solution, USP

0.2%

Antihistamine

Eye Allergy Itch Relief

Works in Minutes

Relief from Allergens:                    ONCE

• Pet Dander • Pollen                   DAILY

• Grass • Ragweed                      STERILE

                                    Two 2.5 mL Bottles

                                    (0.085 FL OZ Each)

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:

Aurohealth LLC

279 Princeton-Hightstown Road

East Windsor, NJ 08520

Made in India

Other Information (Other information)

only for use in the eye
store between 2° to 25°C (39° 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

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

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.

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

AUROHEALTH NDC 58602-007-39

Olopatadine Hydrochloride

Ophthalmic Solution, USP

0.2%

Antihistamine

Eye Allergy Itch 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))

AUROHEALTH             NDC 58602-007-39

                 *Compare to the Active Ingredient in

                        Pataday^® Once Daily Relief

NOW AVAILABLE without a prescription

Olopatadine Hydrochloride

Ophthalmic Solution, USP

0.2%

Antihistamine

Eye Allergy Itch Relief

Works in Minutes

Relief from Allergens:                    ONCE

• Pet Dander • Pollen                   DAILY

• Grass • Ragweed                      STERILE

                                 2.5 mL (0.085 FL OZ)

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

Twin Pack

AUROHEALTH             NDC 58602-007-41

                *Compare to the Active Ingredient in

                            Pataday^® Once Daily Relief

NOW AVAILABLE without a prescription

Olopatadine Hydrochloride

Ophthalmic Solution, USP

0.2%

Antihistamine

Eye Allergy Itch Relief

Works in Minutes

Relief from Allergens:                    ONCE

• Pet Dander • Pollen                   DAILY

• Grass • Ragweed                      STERILE

                                    Two 2.5 mL Bottles

                                    (0.085 FL OZ Each)

Advanced Ingredient Data

[{"name": "OLOPATADINE", "unii": "D27V6190PM", "classCode": "ACTIB", "strengthNumerator": "2", "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": "EDETATE DISODIUM", "unii": "7FLD91C86K", "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": "POVIDONE, UNSPECIFIED", "unii": "FZ989GH94E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM CHLORIDE", "unii": "451W47IQ8X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"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": "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: Aurohealth LLC 279 Princeton-Hightstown Road East Windsor, NJ 08520 Made in India", "Other information": "only for use in the eye store between 2° to 25°C (39° 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 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", "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-0.2% (2.5 mL Container)": "AUROHEALTH NDC 58602-007-39 Olopatadine Hydrochloride Ophthalmic Solution, USP 0.2% Antihistamine Eye Allergy Itch Relief STERILE 2.5 mL (0.085 FL OZ)", "PACKAGE LABEL-PRINCIPAL DISPLAY PANEL-0.2% (2.5 mL Container Carton)": "AUROHEALTH NDC 58602-007-39 *Compare to the Active Ingredient in Pataday ® Once Daily Relief NOW AVAILABLE without a prescription Olopatadine Hydrochloride Ophthalmic Solution, USP 0.2% Antihistamine Eye Allergy Itch Relief Works in Minutes Relief from Allergens: ONCE • Pet Dander • Pollen DAILY • Grass • Ragweed STERILE 2.5 mL (0.085 FL OZ)", "PACKAGE LABEL-PRINCIPAL DISPLAY PANEL-0.2% (2.5 mL Container Carton) Twin Pack": "Twin Pack AUROHEALTH NDC 58602-007-41 *Compare to the Active Ingredient in Pataday ® Once Daily Relief NOW AVAILABLE without a prescription Olopatadine Hydrochloride Ophthalmic Solution, USP 0.2% Antihistamine Eye Allergy Itch Relief Works in Minutes Relief from Allergens: ONCE • Pet Dander • Pollen DAILY • Grass • Ragweed STERILE Two 2.5 mL Bottles (0.085 FL OZ Each)"}