Olopatadine Hydrochloride Ophthalmic Solution: Package Insert and Label Information

OLOPATADINE HYDROCHLORIDE OPHTHALMIC SOLUTION- olopatadine hydrochloride solution/ drops
Rite Aid Corporation

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ACTIVE INGREDIENT

Olopatadine (0.1%) (equivalent to olopatadine hydrochloride 0.111%)

PURPOSE

Antihistamine and redness reliever

USES

temporarily relieves itchy and red 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) twice daily, every 6 to 8 hours, no more than twice 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° to 25°C (39° to 77°F)

INACTIVE INGREDIENTS

Benzalkonium chloride 0.01%, Dibasic sodium phosphate, Hydrochloric acid and /or Sodium hydroxide (to adjust pH), Sodium chloride and Water for Injection.

QUESTIONS?

Call 1-888-375-3784

PRINCIPAL DISPLAY PANEL

Olopatadine
Hydrochloride
Ophthalmic
Solution, USP

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OLOPATADINE HYDROCHLORIDE OPHTHALMIC SOLUTION
olopatadine hydrochloride ophthalmic solution/ drops
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:11822-9976(NDC:43598-765)
Route of Administration OPHTHALMIC DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OLOPATADINE HYDROCHLORIDE (OLOPATADINE) OLOPATADINE 1 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
BENZALKONIUM CHLORIDE
SODIUM PHOSPHATE, DIBASIC
HYDROCHLORIC ACID
SODIUM CHLORIDE
SODIUM HYDROXIDE
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:11822-9976-5 1 BOTTLE, PLASTIC in 1 CARTON contains a BOTTLE, PLASTIC
1 5 mL in 1 BOTTLE, PLASTIC This package is contained within the CARTON (11822-9976-5)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA209619 10/12/2020
Labeler — Rite Aid Corporation (014578892)

Revised: 06/2020 Rite Aid Corporation

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