Drug Facts

Composition & Product

Active Ingredients

Olopatadine (5 mg)

Inactive Ingredients

Povidone, Unspecified Sodium Phosphate, Dibasic, Unspecified Form Sodium Chloride Edetate Disodium Benzalkonium Chloride Hydrochloric Acid Sodium Hydroxide Water

Identifiers & Packaging

Marketing Status

ANDA Active Since 2024-07-05

Medication Information

Description

Active Ingredient Purpose Olopatadine (0.2%)...................................... Antihistamine (equivalent to olopatadine hydrochloride, USP 0.222%)

Use

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

Section 55106-9

Active Ingredient	Purpose
Olopatadine (0.2%)......................................	Antihistamine
(equivalent to olopatadine hydrochloride, USP 0.222%)

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

Questions?

Call (800) 233-5469

M-F 8:30 AM - 5:30 PM CST or

visit www.ocusoft.com

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.

Principal Display Panel

Retaine_®

NDC-54799-25 ALLERGY

OCuSOFT

EYE ALLERGY

ITCH RELIEF

ONCE DAILY

Olopatadine Hydrochloride

Ophthalmic Solution,

USP 0.2% Antihistamine

2.5 mL (0.085 fl oz) Sterile

Only for use in the eye. Store between

2°C to 25°C (36°F to 77°F)

TAMPER EVIDENT: Do not use if ring

at bottom of cap is broken or missing

at the time of purchase

Manufactured for:

OCuSOFT Inc., Rosenberg, TX 77471

Product of India

M.L. No: G/28/1704

20041115

LOT:

EXP:

20041115

R04/24

Retaine_®

ALLERGY

OCuSOFT^®

Eye Allergy

Itch Relief

Olopatadine Hydrochloride

Ophthalmic Solution, USP 0.2%

Antihistamine

ONCE DAILY

Works in Minutes

Relief from Allergens:

· Pet Dander · Pollen

· Grass · Ragweed

Sterile

2.5mL (0.085 fl oz)

OCuSOFT

TAMPER EVIDENT:

Do not use if ring at bottom of

cap is broken or missing at

the time of purchase.

Original Prescription Strength

For Ages 2

and Older

30 DAY

SUPPLY

Once Daily Eye

Allergy Itch

Relief. Works in

Minutes.

Fill Line

Actual Size

OCuSOFT

Manufactured for OCuSOFT Inc.

Rosenberg, TX 77471 USA

(800) 233-5469 wwwocusoft.com

© 2024 OCuSOFT Inc.

® marks owned by OCuSOFT inc.

Product of India

777-3-96 R04/24

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 contact lens if your eye is red

Stop Use and Ask A Doctor

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 right away.

Structured Label Content

Use

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

Section 55106-9 (55106-9)

Active Ingredient	Purpose
Olopatadine (0.2%)......................................	Antihistamine
(equivalent to olopatadine hydrochloride, USP 0.222%)

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

Questions?

Call (800) 233-5469

M-F 8:30 AM - 5:30 PM CST or

visit www.ocusoft.com

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.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Retaine_®

NDC-54799-25 ALLERGY

OCuSOFT

EYE ALLERGY

ITCH RELIEF

ONCE DAILY

Olopatadine Hydrochloride

Ophthalmic Solution,

USP 0.2% Antihistamine

2.5 mL (0.085 fl oz) Sterile

Only for use in the eye. Store between

2°C to 25°C (36°F to 77°F)

TAMPER EVIDENT: Do not use if ring

at bottom of cap is broken or missing

at the time of purchase

Manufactured for:

OCuSOFT Inc., Rosenberg, TX 77471

Product of India

M.L. No: G/28/1704

20041115

LOT:

EXP:

20041115

R04/24

Retaine_®

ALLERGY

OCuSOFT^®

Eye Allergy

Itch Relief

Olopatadine Hydrochloride

Ophthalmic Solution, USP 0.2%

Antihistamine

ONCE DAILY

Works in Minutes

Relief from Allergens:

· Pet Dander · Pollen

· Grass · Ragweed

Sterile

2.5mL (0.085 fl oz)

OCuSOFT

TAMPER EVIDENT:

Do not use if ring at bottom of

cap is broken or missing at

the time of purchase.

Original Prescription Strength

For Ages 2

and Older

30 DAY

SUPPLY

Once Daily Eye

Allergy Itch

Relief. Works in

Minutes.

Fill Line

Actual Size

OCuSOFT

Manufactured for OCuSOFT Inc.

Rosenberg, TX 77471 USA

(800) 233-5469 wwwocusoft.com

© 2024 OCuSOFT Inc.

® marks owned by OCuSOFT inc.

Product of India

777-3-96 R04/24

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 contact lens if your eye is red

Stop Use and Ask A Doctor (Stop use and ask a doctor )

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 right away.

Advanced Ingredient Data

[{"name": "OLOPATADINE", "unii": "D27V6190PM", "classCode": "ACTIB", "strengthNumerator": "5", "strengthDenominator": "2.5", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "Povidone, Unspecified", "unii": "FZ989GH94E", "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": "EDETATE DISODIUM", "unii": "7FLD91C86K", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BENZALKONIUM CHLORIDE", "unii": "F5UM2KM3W7", "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)

{"Use": "temporarily relieves itchy eyes due to pollen, ragweed, grass, animal hair and dander", "55106-9": "Active Ingredient Purpose Olopatadine (0.2%)...................................... Antihistamine (equivalent to olopatadine hydrochloride, USP 0.222%)", "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", "Questions?": "Call (800) 233-5469 M-F 8:30 AM - 5:30 PM CST or visit www.ocusoft.com", "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.", "PRINCIPAL DISPLAY PANEL": "Retaine ® NDC-54799-25 ALLERGY OCuSOFT EYE ALLERGY ITCH RELIEF ONCE DAILY Olopatadine Hydrochloride Ophthalmic Solution, USP 0.2% Antihistamine 2.5 mL (0.085 fl oz) Sterile Only for use in the eye. Store between 2°C to 25°C (36°F to 77°F) TAMPER EVIDENT : Do not use if ring at bottom of cap is broken or missing at the time of purchase Manufactured for: OCuSOFT Inc., Rosenberg, TX 77471 Product of India M.L. No: G/28/1704 20041115 LOT: EXP: 20041115 R04/24 Retaine ® ALLERGY OCuSOFT ® Eye Allergy Itch Relief Olopatadine Hydrochloride Ophthalmic Solution, USP 0.2% Antihistamine ONCE DAILY Works in Minutes Relief from Allergens: · Pet Dander · Pollen · Grass · Ragweed Sterile 2.5mL (0.085 fl oz) OCuSOFT TAMPER EVIDENT: Do not use if ring at bottom of cap is broken or missing at the time of purchase. Original Prescription Strength For Ages 2 and Older 30 DAY SUPPLY Once Daily Eye Allergy Itch Relief. Works in Minutes. Fill Line Actual Size OCuSOFT Manufactured for OCuSOFT Inc. Rosenberg, TX 77471 USA (800) 233-5469 wwwocusoft.com © 2024 OCuSOFT Inc. ® marks owned by OCuSOFT inc. Product of India 777-3-96 R04/24", "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 contact lens if your eye is red", "Stop use and ask a doctor ": "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 right away."}

Drug Facts

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information