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 2020-07-15

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?

✆1-855-274-44122

Distributed by:

AUROHEALTH LLC

2572 Brunswick Pike

Lawrenceville, NJ 08648

Made in India

Code: TS/DRUGS/13/2010

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)

PrimaryHealth NDC 58602-012-40

Olopatadine Hydrochloride

Ophthalmic Solution, USP

0.1%

Antihistamine and Redness Reliever

Eye Allergy Itch & Redness Relief

STERILE 5 mL (0.17 FL OZ)

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

                                                      NDC 58602-012-40

                                                            PrimaryHealth

                              *Compare to the Active Ingredient

                                     in Pataday^® Once Daily Relief

NOW AVAILABLE without a prescription

Olopatadine Hydrochloride

Ophthalmic Solution, USP

0.1%

Antihistamine and Redness Reliever

Eye Allergy Itch & Redness Relief

Works in Minutes

Relief from Allergens:

• Pet Dander • Pollen                     TWICE

• Grass • Ragweed                          DAILY

                                                     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?

✆1-855-274-44122

Distributed by:

AUROHEALTH LLC

2572 Brunswick Pike

Lawrenceville, NJ 08648

Made in India

Code: TS/DRUGS/13/2010

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))

PrimaryHealth NDC 58602-012-40

Olopatadine Hydrochloride

Ophthalmic Solution, USP

0.1%

Antihistamine and Redness Reliever

Eye Allergy Itch & Redness Relief

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))

                                                      NDC 58602-012-40

                                                            PrimaryHealth

                              *Compare to the Active Ingredient

                                     in Pataday^® Once Daily Relief

NOW AVAILABLE without a prescription

Olopatadine Hydrochloride

Ophthalmic Solution, USP

0.1%

Antihistamine and Redness Reliever

Eye Allergy Itch & Redness Relief

Works in Minutes

Relief from Allergens:

• Pet Dander • Pollen                     TWICE

• Grass • Ragweed                          DAILY

                                                     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?": "✆1-855-274-44122 Distributed by: AUROHEALTH LLC 2572 Brunswick Pike Lawrenceville, NJ 08648 Made in India Code: TS/DRUGS/13/2010", "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)": "PrimaryHealth NDC 58602-012-40 Olopatadine Hydrochloride Ophthalmic Solution, USP 0.1% Antihistamine and Redness Reliever Eye Allergy Itch & Redness Relief STERILE 5 mL (0.17 FL OZ)", "PACKAGE LABEL-PRINCIPAL DISPLAY PANEL-0.1% (5 mL Container Carton)": " NDC 58602-012-40 PrimaryHealth *Compare to the Active Ingredient in Pataday ® Once Daily Relief NOW AVAILABLE without a prescription Olopatadine Hydrochloride Ophthalmic Solution, USP 0.1% Antihistamine and Redness Reliever Eye Allergy Itch & Redness Relief Works in Minutes Relief from Allergens: • Pet Dander • Pollen TWICE • Grass • Ragweed DAILY STERILE 5 mL (0.17 FL OZ)"}