Olopatadine Hydrochloride Ophthalmic Solution, Usp, 0.2%

SPL v7

SPL

SPL Set ID 6ee9f8f5-973c-4c71-8069-e76cd87b07dc

Route

OPHTHALMIC

Published

Effective Date 2024-12-20

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Olopatadine (2 mg)

Inactive Ingredients

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

Identifiers & Packaging

Marketing Status

ANDA Active Since 2024-12-20

Description

Drug Facts Active Ingredients Purpose Olopatadine 0.2% (equivalent to olopatadine hydrochloride 0.222%) Antihistamine

Medication Information

Warnings and Precautions

Warnings

For external use only

Indications and Usage

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

Dosage and Administration

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

Description

Drug Facts Active Ingredients Purpose Olopatadine 0.2% (equivalent to olopatadine hydrochloride 0.222%) Antihistamine

Section 42229-5

Manufactured for:

Somerset Therapeutics, LLC

Somerset, NJ 08873

Made in India

Code No.:KR/DRUGS/KTK/28/289/97

1201094

ST-OLO12/P/00

Section 44425-7

Other information

only for use in the eye
store between 2°-25°C (36°-77°F)

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

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

Section 50570-1

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

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

Section 51727-6

Inactive ingredients

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

Section 51945-4

Container Label

NDC 70069-491-01

Olopatadine Hydrochloride Ophthalmic Solution USP, 0.2%

Antihistamine

ONCE DAILY RELIEF

Sterile

2.5 mL (0.085 FL OZ)

Carton Label

Original Prescription Strength

NDC 70069-491-01

Olopatadine Hydrochloride Ophthalmic Solution USP, 0.2%

Antihistamine

ONCE DAILY RELIEF

Eye Allergy Itch Relief

ONCE DAILY

Works in Minutes

Relief from Allergens:

• Pet Dander

• Pollen

• Grass

• Ragweed

Sterile

2.5 mL (0.085 FL OZ)

Section 53413-1

Questions?

Customer Care # 1-800-417-9175

Section 55105-1

Drug Facts

Active Ingredients	Purpose
Olopatadine 0.2% (equivalent to olopatadine hydrochloride 0.222%)	Antihistamine

Structured Label Content

Indications and Usage (34067-9)

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

Dosage and Administration (34068-7)

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

Warnings and Precautions (34071-1)

Warnings

For external use only

Section 42229-5 (42229-5)

Manufactured for:

Somerset Therapeutics, LLC

Somerset, NJ 08873

Made in India

Code No.:KR/DRUGS/KTK/28/289/97

1201094

ST-OLO12/P/00

Section 44425-7 (44425-7)

Other information

only for use in the eye
store between 2°-25°C (36°-77°F)

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

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

Section 50570-1 (50570-1)

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

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

Section 51727-6 (51727-6)

Inactive ingredients

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

Section 51945-4 (51945-4)

Container Label

NDC 70069-491-01

Olopatadine Hydrochloride Ophthalmic Solution USP, 0.2%

Antihistamine

ONCE DAILY RELIEF

Sterile

2.5 mL (0.085 FL OZ)

Carton Label

Original Prescription Strength

NDC 70069-491-01

Olopatadine Hydrochloride Ophthalmic Solution USP, 0.2%

Antihistamine

ONCE DAILY RELIEF

Eye Allergy Itch Relief

ONCE DAILY

Works in Minutes

Relief from Allergens:

• Pet Dander

• Pollen

• Grass

• Ragweed

Sterile

2.5 mL (0.085 FL OZ)

Section 53413-1 (53413-1)

Questions?

Customer Care # 1-800-417-9175

Section 55105-1 (55105-1)

Drug Facts

Active Ingredients	Purpose
Olopatadine 0.2% (equivalent to olopatadine hydrochloride 0.222%)	Antihistamine

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": "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": "SODIUM HYDROXIDE", "unii": "55X04QC32I", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYDROCHLORIC ACID", "unii": "QTT17582CB", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Use temporarily relieves itchy eyes due to pollen, ragweed, grass, animal hair and dander", "34068-7": "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", "34071-1": "Warnings For external use only", "42229-5": "Manufactured for: Somerset Therapeutics, LLC Somerset, NJ 08873 Made in India Code No.:KR/DRUGS/KTK/28/289/97 1201094 ST-OLO12/P/00", "44425-7": "Other information only for use in the eye store between 2°-25°C (36°-77°F)", "50565-1": "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.", "50566-9": "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", "50570-1": "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 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", "51727-6": "Inactive ingredients benzalkonium chloride 0.01%, dibasic sodium phosphate, edetate disodium, hydrochloric acid/sodium hydroxide (adjust pH), povidone, sodium chloride and water for injection", "51945-4": "Container Label NDC 70069-491-01 Olopatadine Hydrochloride Ophthalmic Solution USP, 0.2% Antihistamine ONCE DAILY RELIEF Sterile 2.5 mL (0.085 FL OZ) Carton Label Original Prescription Strength NDC 70069-491-01 Olopatadine Hydrochloride Ophthalmic Solution USP, 0.2% Antihistamine ONCE DAILY RELIEF Eye Allergy Itch Relief ONCE DAILY Works in Minutes Relief from Allergens: • Pet Dander • Pollen • Grass • Ragweed Sterile 2.5 mL (0.085 FL OZ)", "53413-1": "Questions? Customer Care # 1-800-417-9175", "55105-1": "Drug Facts Active Ingredients Purpose Olopatadine 0.2% (equivalent to olopatadine hydrochloride 0.222%) Antihistamine"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:57.792401 · Updated: 2026-03-14T23:06:11.878508