Olopatadine Hydrochloride Ophthalmic Solution: Package Insert and Label Information

OLOPATADINE HYDROCHLORIDE OPHTHALMIC SOLUTION- olopatadine hydrochloride solution
Walgreens Company

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ACTIVE INGREDIENT

Olopatadine (0.2%) (equivalent to olopatadine hydrochloride 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 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 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?

Call 1-888-375-3784

PRINCIPAL DISPLAY PANEL

NDC 0363-7131-25
Olopatadine Hydrochloride
Ophthalmic Solution, USP
0.2%

OLOPATADINE HYDROCHLORIDE OPHTHALMIC SOLUTION olopatadine hydrochloride ophthalmic solution

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-7131(NDC:43598-764) Route of Administration OPHTHALMIC DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OLOPATADINE HYDROCHLORIDE (OLOPATADINE) OLOPATADINE 2 mg in 1 mL

Inactive Ingredients Ingredient Name Strength BENZALKONIUM CHLORIDE SODIUM PHOSPHATE, DIBASIC, ANHYDROUS EDETATE DISODIUM HYDROCHLORIC ACID POVIDONE K30 SODIUM CHLORIDE SODIUM HYDROXIDE WATER

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0363-7131-25 1 BOTTLE, PLASTIC in 1 CARTON contains a BOTTLE, PLASTIC 1 2.5 mL in 1 BOTTLE, PLASTIC This package is contained within the CARTON (0363-7131-25)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA209752 10/12/2020

Labeler — Walgreens Company (008965063)

Revised: 06/2020 Walgreens Company