Olopatadine Hydrochloride Ophthalmic Solution USP, 0.1%TWICE DAILY RELIEF

Drug Facts


Active Ingredients	Purpose
Olopatadine (0.1%) (equivalent to olopatadine hydrochloride 0.111%)	Antihistamine and Redness Reliever

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

Warnings

For external use only

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

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

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

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

Other information

only for use in the eye
store between 4°-25°C (39°-77°F)

Inactive ingredients

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

Questions?

Customer Care # 1-800-417-9175

Manufactured for:

Somerset Therapeutics, LLC

Somerset, NJ 08873

Made in India

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

ST-OLP11-OTC/P/01

1200809

Container Label

NDC 70069-017-01

Olopatadine Hydrochloride Ophthalmic Solution USP, 0.1%

Antihistamine and Redness Reliever

TWICE DAILY RELIEF

Eye Allergy Itch & Redness Relief

Sterile

5 mL (0.017 FL OZ)

Carton Label

Original Prescription Strength

NDC 70069-017-01

Olopatadine Hydrochloride Ophthalmic Solution USP, 0.1%

Antihistamine and Redness Reliever

TWICE DAILY RELIEF

Eye Allergy Itch & Redness Relief

TWICE DAILY

Works in Minutes

Relief from Allergens:

• Pet Dander

• Pollen

• Grass

• Ragweed

Sterile

5 mL (0.017 FL OZ

OLOPATADINE
olopatadine solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70069-017
Route of Administration	OPHTHALMIC

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OLOPATADINE HYDROCHLORIDE (UNII: 2XG66W44KF) (OLOPATADINE - UNII:D27V6190PM)	OLOPATADINE	1 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70069-017-01	1 in 1 CARTON	04/15/2024
1		5 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA206306	04/15/2024

Labeler - Somerset Therapeutics, LLC (079947873)

Registrant - Somerset Therapeutics, LLC (079947873)

Name	Address	ID/FEI	Business Operations
Establishment
Somerset Therapeutics Limited		677236695	ANALYSIS(70069-017) , LABEL(70069-017) , PACK(70069-017) , MANUFACTURE(70069-017)