OLOPATADINE HYDROCHLORIDE solution/ drops

Olopatadine Hydrochloride by

Drug Labeling and Warnings

Olopatadine Hydrochloride by is a Otc medication manufactured, distributed, or labeled by Cipla USA Inc., Cipla Ltd. Indore. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Olopatadine 0.2% (equivalent to olopatadine hydrochloride 0.222%)

PURPOSE

Antihistamine

INDICATIONS AND USAGE

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

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

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.

DIRECTION

●  adults and children 2 years of age and older:

o              put 1 drop in the affected eye(s) once daily, no more than once per day

o              if using other ophthalmic products while using this product, wait at least 5 minutes between each product

o              replace cap after each use

●  children under 2 years of age: consult a doctor

Other Information

● only for use in the eye

● store between 2°-25°C (36°-77°F)

INACTIVE INGREDIENT

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

Questions

Call 1-866-604-3268

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Original Prescription

Strength

NDC: 69097-600-33

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

Cipla

STERILE

2.5 mL (0.085 FL OZ)

NDC: 69097-600-33

Olopatadine

Hydrochloride

Ophthalmic Solution,

USP, 0.2%

Once Daily

Antihistamine

Eye Allergy Itch Relief

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: 69097-600
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OLOPATADINE HYDROCHLORIDE (UNII: 2XG66W44KF) (OLOPATADINE - UNII:D27V6190PM)	OLOPATADINE	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)
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69097-600-33	1 in 1 CARTON	03/19/2021
1		2.5 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA206087	03/19/2021

Labeler - Cipla USA Inc. (078719707)

Registrant - Cipla USA Inc. (078719707)

Establishment
Name	Address	ID/FEI	Business Operations
Cipla Ltd. Indore		918596409	ANALYSIS(69097-600) , MANUFACTURE(69097-600) , LABEL(69097-600) , PACK(69097-600)