OLOPATADINE HYDROCHLORIDE solution

OLOPATADINE HYDROCHLORIDE by

Drug Labeling and Warnings

OLOPATADINE HYDROCHLORIDE by is a Otc medication manufactured, distributed, or labeled by RITE AID CORPORATION, EUGIA PHARMA SPECIALITIES LIMITED. Drug facts, warnings, and ingredients follow.

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 (36° 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


DISTRIBUTED BY:
RITE AID,
200 NEWBERRY COMMONS
ETTERS, PA 17319
www.riteaid.com
MADE IN INDIA

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

                               NDC: 11822-0063-2
EYE ALLERGY                            ONCE DAILY
ITCH RELIEF             
OLOPATADINE HYDROCHLORIDE
OPHTHALMIC SOLUTION
USP, 0.2%
Antihistamine                                    2.5 mL
STERILE                               (0.085 FL OZ)

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

Compare to the active ingredient
in Pataday® Once Daily Relief*
                             NDC: 11822-0063-2
ONCE DAILY RELIEF
EYE ALLERGY
ITCH RELIEF
OLOPATADINE
HYDROCHLORIDE
OPHTHALMIC
SOLUTION USP, 0.2%
Antihistamine
Works in Minutes
Relief from Allergens:
Pet Dander Pollen
Grass Ragweed
                                        STERILE
ONCE DAILY
Now available
without a                                   2.5 mL
prescription                   (0.085 FL OZ)

INGREDIENTS AND APPEARANCE

OLOPATADINE HYDROCHLORIDE 
olopatadine hydrochloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11822-0063
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: 11822-0063-2	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 - RITE AID CORPORATION (014578892)

Establishment
Name	Address	ID/FEI	Business Operations
EUGIA PHARMA SPECIALITIES LIMITED		650498244	ANALYSIS(11822-0063) , MANUFACTURE(11822-0063) , PACK(11822-0063)