OLOPATADINE HYDROCHLORIDE OPHTHALMIC SOLUTION- olopatadine hydrochloride ophthalmic solution/ drops 
Rugby Laboratories

----------

ACTIVE INGREDIENT

Olopatadine (0.1%) (equivalent to olopatadine hydrochloride 0.111%)

PURPOSE

Antihistamine and redness reliever


USES

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


STOP USE AND ASK DOCTOR IF

you experience:  

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° to 25°C (39° 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?

Call 1-888-375-3784

PRINCIPAL DISPLAY PANEL

Olopatadine Hydrochloride
Ophthalmic Solution USP, 0.1%

Carton

OLOPATADINE HYDROCHLORIDE OPHTHALMIC SOLUTION 
olopatadine hydrochloride ophthalmic solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-1308
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OLOPATADINE HYDROCHLORIDE (UNII: 2XG66W44KF) (OLOPATADINE - UNII:D27V6190PM) OLOPATADINE1 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)  
HYDROCHLORIC ACID (UNII: QTT17582CB)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0536-1308-401 in 1 CARTON01/05/2021
15 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20961901/05/2021
Labeler - Rugby Laboratories (079246066)
Establishment
NameAddressID/FEIBusiness Operations
Reed Lane Inc.001819879pack(0536-1308)

Revised: 6/2023
Document Id: 2634b4fc-71ba-e5db-76ad-6ebdc52ae2d3
Set id: d7bcba63-bfaf-240b-199e-2e42a91c19c9
Version: 3
Effective Time: 20230626
 
Rugby Laboratories