OLOPATADINE HYDROCHLORIDE OPHTHALMIC SOLUTION- olopatadine hydrochloride ophthalmic solution/ drops

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 (0.1%) (equivalent to olopatadine hydrochloride 0.111%)

PURPOSE

Antihistamine and redness reliever

USES

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 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° to 25°C (39° to 77°F)

INACTIVE INGREDIENTS

Benzalkonium chloride 0.01%, Dibasic sodium phosphate, Hydrochloric acid and /or Sodium hydroxide (to adjust pH), 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: 68083-477-01
Olopatadine
Hydrochloride
Ophthalmic
Solution, USP
Bottle Label:


Carton Label:

INGREDIENTS AND APPEARANCE

OLOPATADINE HYDROCHLORIDE OPHTHALMIC SOLUTION 
olopatadine hydrochloride ophthalmic solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68083-477
Route of Administration	OPHTHALMIC

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

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68083-477-01	1 in 1 CARTON	02/14/2017
1		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	ANDA209619	02/14/2017

Labeler - Gland Pharma Limited (918601238)

Establishment
Name	Address	ID/FEI	Business Operations
Gland Pharma Limited		918601238	ANALYSIS(68083-477) , MANUFACTURE(68083-477) , PACK(68083-477)