OLOPATADINE HYDROCHLORIDE- olopatadine hydrochloride solution/ drops

United States - English - NLM (National Library of Medicine)

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Active ingredient:
OLOPATADINE HYDROCHLORIDE (UNII: 2XG66W44KF) (OLOPATADINE - UNII:D27V6190PM)
Available from:
Micro Labs Limited
Administration route:
OPHTHALMIC
Prescription type:
OTC DRUG
Therapeutic indications:
Antihistamine temporarily relieves itchy eyes due to pollen, ragweed, grass, animal hair and dander - if solution changes color or becomes cloudy - if you are sensitive to any ingredient in this product - to treat contact lens related irritation - eye pain - changes in vision - increased redness of the eye - itching worsens or lasts for more than 72 hours
Authorization status:
Abbreviated New Drug Application
Authorization number:
42571-152-35

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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%)

Purpos e

Antihistamine

Us es

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 T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:42571-152

Route of Administration

OPHTHALMIC

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

Micro Labs Limited

O LO PATADINE HYDRO CHLO RIDE (UNII: 2XG6 6 W44KF) (OLOPATADINE -

UNII:D27V6 19 0 PM)

OLOPATADINE

HYDROCHLORIDE

2 mg

in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

SO DIUM PHO SPHATE, DIBASIC, ANHYDRO US (UNII: 22ADO53M6 F)

EDETATE DISO DIUM (UNII: 7FLD9 1C8 6 K)

PO VIDO NE K3 0 (UNII: U725QWY32X)

SO DIUM CHLO RIDE (UNII: 451W47IQ8 X)

BENZALKO NIUM CHLO RIDE (UNII: F5UM2KM3W7)

HYDRO CHLO RIC ACID (UNII: QTT1758 2CB)

SO DIUM HYDRO XIDE (UNII: 55X0 4QC32I)

WATER (UNII: 0 59 QF0 KO0 R)

Product Characteristics

Color

white (co lo rless to nearly co lo rless)

S core

S hap e

S iz e

Flavor

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:42571-152-35

1 in 1 CARTON

12/16 /20 20

1

2.5 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA20 46 20

12/16 /20 20

Labeler -

Micro Labs Limited (862174955)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Micro Labs Limited

6 776 0 0 48 2

analysis(42571-152) , label(42571-152) , manufacture(42571-152) , pack(42571-152)

Revised: 6/2020

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