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, GLAND PHARMA LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Olopatadine (0.7%)............(equivalent to olopatadine hydrochloride 0.776%)

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 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) once daily
  • do not use more than 1 drop in each eye per day
  • if using other ophthalmic products while using this product, wait at least 5minutes 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° - 25°C (36° - 77°F)

INACTIVE INGREDIENTS

benzalkonium chloride 0.015% (preservative), boric acid, hydrochloric acid/sodium hydroxide (to adjust pH), hydroxypropyl-gamma-cyclodextrin, hypromellose, mannitol, polyethylene glycol 400, povidone, and purified water.

QUESTIONS?

call 866-770-7144 (Monday – Friday 9:00 AM to 6:00 PM EST)

PRINCIPAL DISPLAY PANEL

Carton Label:

EXTRA STRENGTH

NDC 68083-398-01
Olopatadine
Hydrochloride
Ophthalmic
Solution, USP
0.7%
Antihistamine
ONCE DAILY RELIEF
Eye Allergy Itch Relief

FULL
24
HOUR

Works in Minutes
2.5 mL (0.085 fl oz)
STERILE 

Bottle Label:
NDC 68083-398-01
EXTRA STRENGTH
Olopatadine
Hydrochloride
Ophthalmic
Solution, USP
0.7%
Antihistamine
ONCE DAILY RELIEF
EYE ALLERGY ITCH RELIEF

STERILE

2.5 mL (0.085 fl oz)

INGREDIENTS AND APPEARANCE

OLOPATADINE HYDROCHLORIDE OPHTHALMIC SOLUTION 
olopatadine hydrochloride ophthalmic solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68083-398
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OLOPATADINE HYDROCHLORIDE (UNII: 2XG66W44KF) (OLOPATADINE - UNII:D27V6190PM)	OLOPATADINE	7 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
BORIC ACID (UNII: R57ZHV85D4)
HYDROCHLORIC ACID (UNII: QTT17582CB)
HYDROXYPROPYL .GAMMA.-CYCLODEXTRIN (UNII: P6BYU725IU)
HYPROMELLOSE 2910 (4000 MPA.S) (UNII: RN3152OP35)
MANNITOL (UNII: 3OWL53L36A)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
POVIDONE K30 (UNII: U725QWY32X)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68083-398-01	1 in 1 CARTON	01/06/2026
1		2.5 mL in 1 BOTTLE, PLASTIC; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA213514	01/06/2026

Labeler - Gland Pharma Limited (918601238)

Establishment
Name	Address	ID/FEI	Business Operations
GLAND PHARMA LIMITED		918601238	ANALYSIS(68083-398) , LABEL(68083-398) , MANUFACTURE(68083-398) , PACK(68083-398)