LUMIFY REDNESS RELIEVER EYE DROPS- brimonidine tartrate solution/ drops

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

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Active ingredient:
BRIMONIDINE TARTRATE (UNII: 4S9CL2DY2H) (BRIMONIDINE - UNII:E6GNX3HHTE)
Available from:
Bausch & Lomb Incorporated
Administration route:
OPHTHALMIC
Prescription type:
OTC DRUG
Therapeutic indications:
Redness reliever
Authorization status:
New Drug Application
Authorization number:
24208-537-01, 24208-537-08, 24208-537-10, 24208-537-15, 24208-537-25, 24208-537-75, 24208-537-99

LUMIFY REDNESS RELIEVER EYE DROPS- brimonidine tartrate solution/ drops

Bausch & Lomb Incorporated

----------

Drug Facts

Active ingredient

Brimonidine tartrate (0.025%)

Purpos e

Redness reliever

Us e

Warnings

For external use only

Do not use

Stop use and ask a doctor if

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right

away.

Directions

Other information

relieves redness of the eye due to minor eye irritations

if solution changes color or becomes cloudy

you experience eye pain, changes in vision, continued redness or irritation of the eye

condition worsens or persists for more than 3 days

adults and children 5 years of age and over:

instill 1 drop in the affected eye(s) every 6-8 hours

do not use more than 4 times daily

remove contact lenses before use

wait at least 10 minutes before re-inserting contact lenses after use

if using other ophthalmic products while using this product, wait at least 5 minutes between each

product

to avoid contamination, do not touch tip of container to any surface

replace cap after each use

children under 5 years of age: consult a doctor

Inactive ingredients

benzalkonium chloride, boric acid, calcium chloride dihydrate, glycerin, potassium chloride, sodium

borate decahydrate, sodium chloride. water for injection. Hydrochloric acid and/or sodium hydroxide

may be used to adjust pH.

Questions or comments?

Call: 1-800-553-5340

PRINCIPAL DISPLAY PANEL - 7.5 mL Carton

BAUSCH + LOMB

NDC 24208-537-25

NEW PRODUCT

[eye image]

LUMIFY

BRIMONIDINE TARTRATE

OPHTHALMIC SOLUTION 0.025%

REDNESS RELIEVER EYE DROPS

Sterile

0.25 FL OZ (7.5 mL)

store at 15°-25°C (59°-77°F)

Works in 1 minute

Lasts up to 8 hours

LUMIFY REDNESS RELIEVER EYE DROPS

brimonidine tartrate solution/ drops

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:2420 8 -537

Route of Administration

OPHTHALMIC

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

BRIMO NIDINE TARTRATE (UNII: 4S9 CL2DY2H) (BRIMONIDINE - UNII:E6 GNX3HHTE)

BRIMONIDINE TARTRATE 0 .25 mg in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

BENZALKO NIUM CHLO RIDE (UNII: F5UM2KM3W7)

BO RIC ACID (UNII: R57ZHV8 5D4)

CALCIUM CHLO RIDE (UNII: M4I0 D6 VV5M)

GLYCERIN (UNII: PDC6 A3C0 OX)

PO TASSIUM CHLO RIDE (UNII: 6 6 0 YQ9 8 I10 )

SO DIUM BO RATE (UNII: 9 1MBZ8 H3QO)

SO DIUM CHLO RIDE (UNII: 451W47IQ8 X)

WATER (UNII: 0 59 QF0 KO0 R)

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:2420 8 -537-

1 in 1 CARTON

12/22/20 17

1

7.5 mL in 1 BOTTLE, DROPPER; Type 0 : No t a Co mbinatio n

Pro duc t

2

NDC:2420 8 -537-

1 in 1 CARTON

12/22/20 17

2

2.5 mL in 1 BOTTLE, DROPPER; Type 0 : No t a Co mbinatio n

Pro duc t

3

NDC:2420 8 -537-

1 in 1 CARTON

12/22/20 17

3

2.5 mL in 1 BOTTLE, DROPPER; Type 0 : No t a Co mbinatio n

Pro duc t

4

NDC:2420 8 -537-

1 in 1 CARTON

12/22/20 17

4

7.5 mL in 1 BOTTLE, DROPPER; Type 0 : No t a Co mbinatio n

Pro duc t

5

NDC:2420 8 -537-

1 in 1 CARTON

0 5/0 1/20 19

5

0 .4 mL in 1 AMPULE; Type 0 : No t a Co mbinatio n Pro duct

6

NDC:2420 8 -537-

1 in 1 CARTON

0 5/0 1/20 19

6

0 .4 mL in 1 AMPULE; 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

NDA20 8 144

12/22/20 17

Labeler -

Bausch & Lomb Incorporated (196603781)

Bausch & Lomb Incorporated

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Bausch & Lo mb Inco rpo rated

0 79 58 76 25

MANUFACTURE(2420 8 -537)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Labo rato ire Unither

574139 8 0 9

MANUFACTURE(2420 8 -537)

Revised: 5/2019

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