OLOPATADINE HYDROCHLORIDE- olopatadine hydrochloride solution 
Rising Pharma Holdings, Inc.

----------

Olopatadine Hydrochloride Ophthalmic Solution, USP 0.2%

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

olapatadine-0.2-carton.jpg

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

olapatadine-0.2-container.jpg

OLOPATADINE HYDROCHLORIDE 
olopatadine hydrochloride solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:16571-861
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OLOPATADINE HYDROCHLORIDE (UNII: 2XG66W44KF) (OLOPATADINE - UNII:D27V6190PM) OLOPATADINE2 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:16571-861-251 in 1 CARTON03/07/2025
12.5 mL in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20462003/07/2025
Labeler - Rising Pharma Holdings, Inc. (116880195)
Establishment
NameAddressID/FEIBusiness Operations
Micro Labs Limited677600482ANALYSIS(16571-861) , LABEL(16571-861) , MANUFACTURE(16571-861) , PACK(16571-861)

Revised: 3/2025
Document Id: 0988e6e2-59a9-47dc-9386-9e9ea877e6c1
Set id: 0988e6e2-59a9-47dc-9386-9e9ea877e6c1
Version: 1
Effective Time: 20250307
 
Rising Pharma Holdings, Inc.