OLOPATADINE HYDROCHLORIDE solution/ drops

OLOPATADINE HYDROCHLORIDE by

Drug Labeling and Warnings

OLOPATADINE HYDROCHLORIDE by is a Otc medication manufactured, distributed, or labeled by Somerset Therapeutics, LLC, Somerset Therapeutics Private Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

PURPOSE

Drug Facts

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

INDICATIONS & USAGE

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

WARNINGS

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

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

DOSAGE & 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

STORAGE AND HANDLING

Other information 

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

INACTIVE INGREDIENT

Inactive ingredients

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

QUESTIONS

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

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)

INGREDIENTS AND APPEARANCE

OLOPATADINE HYDROCHLORIDE 
olopatadine hydrochloride solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70069-491
Route of Administration	OPHTHALMIC

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

Inactive Ingredients
Ingredient Name	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM (UNII: GR686LBA74)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
HYDROCHLORIC ACID (UNII: QTT17582CB)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70069-491-01	2.5 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/20/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA215006	12/20/2024

Labeler - Somerset Therapeutics, LLC (079947873)

Registrant - Somerset Therapeutics, LLC (079947873)

Establishment
Name	Address	ID/FEI	Business Operations
Somerset Therapeutics Private Limited		677236695	ANALYSIS(70069-491) , LABEL(70069-491) , PACK(70069-491) , MANUFACTURE(70069-491)