OLOPATADINE HYDROCHLORIDE solution

OLOPATADINE HYDROCHLORIDE by

Drug Labeling and Warnings

OLOPATADINE HYDROCHLORIDE by is a Otc medication manufactured, distributed, or labeled by WALGREEN CO., Aurobindo Pharma 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?

✆1-800-925-4733

Distributed by:
WALGREEN CO.
200 WILMOT RD., DEERFIELD, IL 60015

Made in India

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

Walgreens                NDC: 0363-8022-39
Eye Allergy Itch Relief
OLOPATADINE HYDROCHLORIDE OPHTHALMIC
SOLUTION USP, 0.2%
ANTIHISTAMINE
Once Daily          2.5 mL (0.085 FL OZ)

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

ORIGINAL PRESCRIPTION STRENGTH
                                           NDC: 0363-8022-39
Walgreens
Compare to the active ingredient in
Pataday® Once Daily Relief‡‡
Eye Allergy
Itch Relief
OLOPATADINE HYDROCHLORIDE
OPHTHALMIC SOLUTION USP, 0.2%
ANTIHISTAMINE
Once Daily
  Works in minutes
  Relief from allergens:
    pet dander, grass,
    pollen & ragweed
  Sterile
2.5 mL (0.085 FL OZ)

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

TWIN PACK

ORINIGAL PRESCRIPTION STRENGTH

                                         NDC: 0363-8022-41
Walgreens
Compare to the active ingredient in
Pataday® Once Daily Relief‡‡

Eye Allergy
Itch Relief
OLOPATADINE HYDROCHLORIDE
OPHTHALMIC SOLUTION USP, 0.2%
ANTIHISTAMINE

Once Daily
Works in minutes
Relief from allergens:
   pet dander, grass,
   pollen & ragweed
Sterile

TWO 2.5 mL BOTTLES
(0.085 FL OZ each)

INGREDIENTS AND APPEARANCE

OLOPATADINE HYDROCHLORIDE 
olopatadine hydrochloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0363-8022
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: 0363-8022-39	1 in 1 CARTON	07/15/2020
1		2.5 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2	NDC: 0363-8022-41	2 in 1 CARTON	07/15/2020
2		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 - WALGREEN CO. (008965063)

Registrant - EUGIA Pharma Specialities Limited (650804896)

Establishment
Name	Address	ID/FEI	Business Operations
Eugia Pharma Specialities Limited		650498244	ANALYSIS(0363-8022) , MANUFACTURE(0363-8022)