OLOPATADINE HYDROCHLORIDE OPHTHALMIC SOLUTION- olopatadine hydrochloride ophthalmic solution

Olopatadine Hydrochloride Ophthalmic Solution by

Drug Labeling and Warnings

Olopatadine Hydrochloride Ophthalmic Solution by is a Otc medication manufactured, distributed, or labeled by Gland Pharma Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Olopatadine (0.2%)  (equivalent to olopatadine hydrochloride 0.222%)

PURPOSE

Antihistamine

USE

temporarily relieves itchy 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 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) 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

OTHER INFORMATION

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

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?

contact Gland Pharma at 864-879-9994 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

PRINCIPAL DISPLAY PANEL

NDC: 68083-231-01
Olopatadine Hydrochloride
Ophthalmic Solution, USP
0.2%
Bottle Label:
 
Olopatadine Hydrochloride
Ophthalmic Solution, USP
0.2%
Carton Label:
 














 

INGREDIENTS AND APPEARANCE

OLOPATADINE HYDROCHLORIDE OPHTHALMIC SOLUTION 
olopatadine hydrochloride ophthalmic solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68083-231
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)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
EDETATE DISODIUM (UNII: 7FLD91C86K)
HYDROCHLORIC ACID (UNII: QTT17582CB)
POVIDONE K30 (UNII: U725QWY32X)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68083-231-01	1 in 1 CARTON	05/20/2020
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	ANDA209752	05/20/2020

Labeler - Gland Pharma Limited (918601238)

Establishment
Name	Address	ID/FEI	Business Operations
Gland Pharma Limited		918601238	ANALYSIS(68083-231) , MANUFACTURE(68083-231) , PACK(68083-231)