Drug Facts

OLOPATADINE HYDROCHLORIDE by

Drug Labeling and Warnings

OLOPATADINE HYDROCHLORIDE by is a Otc medication manufactured, distributed, or labeled by Micro Labs Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

OLOPATADINE HYDROCHLORIDE- olopatadine hydrochloride solution/ drops 
Micro Labs Limited

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Drug Facts

Active ingredient

Olopatadine 0.2% (equivalent to olopatadine hydrochloride 0.222%)

Purpose

Antihistamine

Uses

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 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 4° and 25°C (39° and 77°F)

Inactive ingredients

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

Questions or comments?

call 1-855-839-8195

PRINCIPAL DISPLAY PANEL

NDC: 42571-152-35
Olopatadine Hydrochloride
Opthalmic Solution
USP, 0.2%
2.5 mL
Antihistamine
Once Daily relif
Micro Labs

NDC: 42571-152-35
Olopatadine Hydrochloride
Opthalmic Solution
USP, 0.2%
2.5 mL
Antihistamine
works in minutes
Once Daily relif
Micro Labs

OLOPATADINE HYDROCHLORIDE 
olopatadine hydrochloride solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42571-152
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
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
EDETATE DISODIUM (UNII: 7FLD91C86K)
POVIDONE K30 (UNII: U725QWY32X)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	white (colorless to nearly colorless)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42571-152-35	1 in 1 CARTON	12/16/2020	01/01/2021
1		2.5 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA204620	12/16/2020	01/01/2021

Labeler - Micro Labs Limited (862174955)

Revised: 6/2020

Document Id: a118dd0f-34b9-42f7-a677-08f22d5d1fa5

34390-5

Set id: 32b06078-3024-4095-aad2-f105c5eaeba4

Version: 3

Effective Time: 20200623