Leader Olopatadine Hydrochloride Ophthalmic Solution Usp, 0.2%

SPL v2

SPL

SPL Set ID 71d922d2-22a5-4103-a3eb-126094ee8ef5

Route

OPHTHALMIC

Published

Effective Date 2025-01-28

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Olopatadine (2 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 2025-04-15

Description

Olopatadine (0.2%) (equivalent to olopatadine hydrochloride 0.222%)

Purpose

Antihistamine

Medication Information

Purpose

Antihistamine

Description

Olopatadine (0.2%) (equivalent to olopatadine hydrochloride 0.222%)

Uses

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

Questions?

Call1-877-758-1480

Active Ingredient

Olopatadine (0.2%)

(equivalent to olopatadine hydrochloride 0.222%)

Other Information

only for use in the eye
store between 4 ^—25 °C (39 ^—77 °F)
protect from light

Inactive Ingredients

benzalkonium chloride 0.01%, dibasic sodium phosphate, edetate disodium, hydrochloric acid/sodium hydroxide (to adjust pH), povidone, sodium chloride and water for injection

Principle Display Panel

NDC 70000-0716-1

Olopatadine

Hydrochloride

Ophthalmic

Solution USP, 0.2%

Antihistamine

Once Daily

Eye Allergy

Itch Relief

Works in Minutes

Relief from Allergens:

Pet Dander

Pollen,Grass

Ragweed

ORIGINAL

PRESCRIPTION

STRENGTH

STERILE

3.5 ml (0.12 FL OZ)

2007701

FB61705

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 Reach of Children.

If swallowed, get medical help or contact a Poison Control Center 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

Structured Label Content

Uses

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

Questions?

Call1-877-758-1480

Active Ingredient (Active ingredient)

Olopatadine (0.2%)

(equivalent to olopatadine hydrochloride 0.222%)

Other Information (Other information)

only for use in the eye
store between 4 ^—25 °C (39 ^—77 °F)
protect from light

Inactive Ingredients (Inactive ingredients)

benzalkonium chloride 0.01%, dibasic sodium phosphate, edetate disodium, hydrochloric acid/sodium hydroxide (to adjust pH), povidone, sodium chloride and water for injection

Principle Display Panel

NDC 70000-0716-1

Olopatadine

Hydrochloride

Ophthalmic

Solution USP, 0.2%

Antihistamine

Once Daily

Eye Allergy

Itch Relief

Works in Minutes

Relief from Allergens:

Pet Dander

Pollen,Grass

Ragweed

ORIGINAL

PRESCRIPTION

STRENGTH

STERILE

3.5 ml (0.12 FL OZ)

2007701

FB61705

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 Reach of Children. (Keep out reach of children.)

If swallowed, get medical help or contact a Poison Control Center 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

Advanced Ingredient Data

[{"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": ""}, {"name": "OLOPATADINE", "unii": "D27V6190PM", "classCode": "ACTIM", "strengthNumerator": "2", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"Uses": "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", "Questions?": "Call 1-877-758-1480", "Active ingredient": "Olopatadine (0.2%) (equivalent to olopatadine hydrochloride 0.222%)", "Other information": "only for use in the eye store between 4 — 25 °C (39 — 77 °F) protect from light", "Inactive ingredients": "benzalkonium chloride 0.01%, dibasic sodium phosphate, edetate disodium, hydrochloric acid/sodium hydroxide (to adjust pH), povidone, sodium chloride and water for injection", "Principle Display Panel": "NDC 70000-0716-1 Olopatadine Hydrochloride Ophthalmic Solution USP, 0.2% Antihistamine Once Daily Eye Allergy Itch Relief Works in Minutes Relief from Allergens: Pet Dander Pollen,Grass Ragweed ORIGINAL PRESCRIPTION STRENGTH STERILE 3.5 ml (0.12 FL OZ) 2007701 FB61705", "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 reach of children.": "If swallowed, get medical help or contact a Poison Control Center 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"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:54.867306 · Updated: 2026-03-14T23:08:21.075335