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

PURPOSE

Antihistamine and redness reliever

USE(S)

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°C to 25°C (39°F to 77°F) 

Inactive ingredients

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

Questions?

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

PRINCIPAL DISPLAY PANEL

Rising                                  NDC: 16571-882-05

Olopatadine Hydrochloride Ophthalmic Solution, USP 0.1%

Antihistamine and Redness Reliever

NOW AVAILABLE without a prescription
TWICE DAILY 

Eye Allergy Itch & Redness Relief

Works in Minutes Relief from Allergens:
Pet Dander
Grass
Pollen
Ragweed

5 mL (0.17 FL OZ)                    STERILE

Rising                            NDC 16571-882-05

Olopatadine Hydrochloride Ophthalmic Solution, USP
0.1%
Antihistamine and Redness Reliever
Eye Allergy Itch & Redness Relief
TWICE DAILY
5 mL (0.17 FL OZ)
STERILE

INGREDIENTS AND APPEARANCE

OLOPATADINE HYDROCHLORIDE 
olopatadine hydrochloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 16571-882
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, ANHYDROUS (UNII: 22ADO53M6F)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 16571-882-05	1 in 1 CARTON	03/05/2025
1		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	ANDA204392	03/05/2025

Labeler - Rising Pharma Holdings, Inc. (116880195)

Establishment
Name	Address	ID/FEI	Business Operations
Micro Labs Limited		677600482	ANALYSIS(16571-882) , LABEL(16571-882) , MANUFACTURE(16571-882) , PACK(16571-882)