OLOPATADINE HYDROCHLORIDE- olopatadine hydrochloride solution/ drops 
Micro Labs Limited

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Drug Facts

Active ingredient

Olopatadine 0.2% (equivalent to olopatadine hydrochloride 0.222%)

Purpose

Antihistamine

Uses

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 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.

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) 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° and 25°C (39° and 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 or comments?

call 1-855-839-8195

PRINCIPAL DISPLAY PANEL

NDC 42571-152-35
Olopatadine Hydrochloride
Opthalmic Solution
USP, 0.2%
2.5 mL
Antihistamine
Once Daily relif
Micro Labs

container label

NDC 42571-152-35
Olopatadine Hydrochloride
Opthalmic Solution
USP, 0.2%
2.5 mL
Antihistamine
works in minutes
Once Daily relif
Micro Labs

carton label
OLOPATADINE HYDROCHLORIDE 
olopatadine hydrochloride solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42571-152
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OLOPATADINE HYDROCHLORIDE (UNII: 2XG66W44KF) (OLOPATADINE - UNII:D27V6190PM) OLOPATADINE HYDROCHLORIDE2 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
POVIDONE K30 (UNII: U725QWY32X)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
HYDROCHLORIC ACID (UNII: QTT17582CB)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
Colorwhite (colorless to nearly colorless) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42571-152-351 in 1 CARTON12/16/202001/01/2021
12.5 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20462012/16/202001/01/2021
Labeler - Micro Labs Limited (862174955)

Revised: 6/2020
 
Micro Labs Limited