OLOPATADINE HYDROCHLORIDE solution

Drug Labeling and Warnings

Drug Details [pdf]

Drug Facts

Active ingredient
Olopatadine (0.2%)
(equivalent to olopatadine hydrochloride, USP 0.222%)

Purpose

Antihistamine

Use

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 (1-800-222-1222) 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 2° to 25°C (39° to 77°F)

Inactive ingredients

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

Questions?

✆1-855-274-4122

PROUDLY DISTRIBUTED BY:
ASSOCIATED WHOLESALE GROCERS, INC.
KANSAS CITY, KANSAS 66106

For Product Information, please visit: bestchoicebrand.com/66602

MADE IN INDIA

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL-0.2% (2.5 mL Container)

Best Choice®

ANTIHISTAMINE

ONCE DAILY

Eye Allergy Itch Relief

OLOPATADINE HYDROCHLORIDE
OPHTHALMIC SOLUTION, USP

0.2% 2.5 mL (0.085 FL OZ)          STERILE

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL-0.2% (2.5 mL Container Carton)

Best Choice®

 Compare to the Active Ingredient in

Pataday® Once Daily Relief*

ANTIHISTAMINE
Eye Allergy Itch Relief

OLOPATADINE HYDROCHLORIDE
OPHTHALMIC SOLUTION, USP
0.2%
Works in Minutes
Relief from Allergens: 
Pet Dander

  Pollen
Grass                                 ONCE DAILY

  Ragweed                      STERILE

                                 2.5 mL (0.085 FL OZ)

INGREDIENTS AND APPEARANCE

OLOPATADINE HYDROCHLORIDE 
olopatadine hydrochloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63941-024
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OLOPATADINE HYDROCHLORIDE (UNII: 2XG66W44KF) (OLOPATADINE - UNII:D27V6190PM)	OLOPATADINE HYDROCHLORIDE	2 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM (UNII: GR686LBA74)
EDETATE DISODIUM (UNII: 7FLD91C86K)
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63941-024-39	1 in 1 CARTON	07/15/2020
1		2.5 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA209995	07/15/2020

Labeler - Best Choice (868703513)

Establishment
Name	Address	ID/FEI	Business Operations
EUGIA PHARMA SPECIALITIES LIMITED		650498244	ANALYSIS(63941-024) , MANUFACTURE(63941-024)