OLOPATADINE HYDROCHLORIDE- olopatadine hydrochloride ophthalmic solution

OLOPATADINE HYDROCHLORIDE by

Drug Labeling and Warnings

OLOPATADINE HYDROCHLORIDE by is a Otc medication manufactured, distributed, or labeled by GLENMARK THERAPEUTICS INC., USA, SamChunDang Pharm Co, Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

• Active Ingredient:

  Purpose

• Olopatadine (0.1%). (equivalent to olopatadine hydrochloride 0.111%):

  Antihistamine and redness reliever

INDICATIONS & USAGE

Uses

temporarily relieves itchy and red 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

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.

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°C to 25°C (39°F 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 or comments?

In the U.S., call weekdays 9 AM to 6 PM at 1 (888) 721-7115.

Distributed by:

Glenmark Therapeutics Inc., USA

Mahwah, NJ 07430

Product of Spain

May 2023

PRINCIPAL DISPLAY PANEL

NDC: 72657-168-50

Olopatadine hydrochloride ophthalmic solution 0.1%

Antihistamine and Redness Reliever

Twice Daily Relief
Eye Allergy Itch & Redness Relief

5 mL
STERILE

NDC: 72657-168-50

Olopatadine hydrochloride ophthalmic solution 0.1%

Antihistamine and Redness Reliever

Twice Daily Relief
Eye Allergy Itch & Redness Relief

5 mL
STERILE

INGREDIENTS AND APPEARANCE

OLOPATADINE HYDROCHLORIDE 
olopatadine hydrochloride ophthalmic solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72657-168
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)
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72657-168-50	1 in 1 CARTON	07/26/2024
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	ANDA200810	07/26/2024

Labeler - GLENMARK THERAPEUTICS INC., USA (969085666)

Establishment
Name	Address	ID/FEI	Business Operations
SamChunDang Pharm Co, Ltd		687792325	MANUFACTURE(72657-168)