OLOPATADINE HYDROCHLORIDE solution

olopatadine hydrochloride by

Drug Labeling and Warnings

olopatadine hydrochloride by is a Otc medication manufactured, distributed, or labeled by Rising Pharma Holdings, Inc., Micro Labs Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT(S)

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

PURPOSE

Antihistamine 

USE(S)

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 eyes(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 4°C to 25°C (39°F to 77°F) 

Inactive ingredients

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

Questions?

Contact Rising Pharma Holdings, Inc. at 1-844-474-7464

PRINCIPAL DISPLAY PANEL

Rising                                  NDC: 16571-861-25

Olopatadine Hydrochloride Ophthalmic Solution, USP 0.2%

ONCE DAILY RELIEF Antihistamine

NOW AVAILABLE without a prescription
ONCE DAILY 

Eye Allergy Itch Relief

Works in Minutes

Relief from Allergens:
Pet Dander

Pollen

Grass

Ragweed

2.5 mL                 STERILE

Rising                            NDC 16571-861-25

Olopatadine Hydrochloride Ophthalmic Solution, USP
0.2%
ONCE DAILY RELIEF Antihistamine
Eye Allergy Itch Relief
ONCE DAILY
2.5 mL 
STERILE

INGREDIENTS AND APPEARANCE

OLOPATADINE HYDROCHLORIDE 
olopatadine hydrochloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 16571-861
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)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
WATER (UNII: 059QF0KO0R)
POVIDONE K30 (UNII: U725QWY32X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 16571-861-25	1 in 1 CARTON	03/07/2025
1		2.5 mL in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA204620	03/07/2025

Labeler - Rising Pharma Holdings, Inc. (116880195)

Establishment
Name	Address	ID/FEI	Business Operations
Micro Labs Limited		677600482	ANALYSIS(16571-861) , LABEL(16571-861) , MANUFACTURE(16571-861) , PACK(16571-861)