Olopatadine Hydrochloride Ophthalmic Solution, USP, 0.2%

Label at a glance#

Contacts and useful links#

Label contents#

Full prescribing information#

OTC - PURPOSE SECTION

Drug Facts

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

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

Warnings

For external use only

OTC - DO NOT USE SECTION

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

OTC - STOP USE SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

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

STORAGE AND HANDLING SECTION

Other information 

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

INACTIVE INGREDIENT SECTION

Inactive ingredients

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

OTC - QUESTIONS SECTION

Questions?

Customer Care # 1-800-417-9175

SPL UNCLASSIFIED SECTION

Manufactured for:

Somerset Therapeutics, LLC

Somerset, NJ 08873

Made in India

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

1201094

ST-OLO12/P/00

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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)

DailyMed Product Concepts#

DailyMed Billing Units#

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 10 matching rows.

• OLOPATADINE HYDROCHLORIDE
• OLOPATADINE
• BENZALKONIUM CHLORIDE
• POVIDONE, UNSPECIFIED
• SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM
• SODIUM CHLORIDE
• EDETATE DISODIUM
• SODIUM HYDROXIDE
• HYDROCHLORIC ACID
• WATER

NDC Codes#

Ingredients#

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DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

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Observed Orange Book product history#

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Reported adverse events (FAERS/openFDA)#

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