LUMIFY REDNESS RELIEVER EYE DROPS- brimonidine tartrate solution/ drops

LUMIFY Redness Reliever Eye Drops by

Drug Labeling and Warnings

LUMIFY Redness Reliever Eye Drops by is a Otc medication manufactured, distributed, or labeled by Bausch & Lomb Incorporated, Laboratoire Unither. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Brimonidine tartrate (0.025%)

Purpose

Redness reliever

Use

• relieves redness of the eye due to minor eye irritations

Warnings

For external use only

Do not use

• if solution changes color or becomes cloudy

Stop use and ask a doctor if

• you experience eye pain, changes in vision, continued redness or irritation of the eye
• condition worsens or persists for more than 3 days

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

• 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

Other information

• store at 15°-25°C (59°-77°F)

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

[eye image]

LUMIFY®

BRIMONIDINE TARTRATE

OPHTHALMIC SOLUTION 0.025%

REDNESS RELIEVER EYE DROPS

• Works in 1 minute
• Lasts up to 8 hours

Sterile 0.25 FL OZ (7.5 mL)

INGREDIENTS AND APPEARANCE

LUMIFY REDNESS RELIEVER EYE DROPS 
brimonidine tartrate solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 24208-537
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BRIMONIDINE TARTRATE (UNII: 4S9CL2DY2H) (BRIMONIDINE - UNII:E6GNX3HHTE)	BRIMONIDINE TARTRATE	0.25 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
BORIC ACID (UNII: R57ZHV85D4)
CALCIUM CHLORIDE (UNII: M4I0D6VV5M)
GLYCERIN (UNII: PDC6A3C0OX)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
SODIUM BORATE (UNII: 91MBZ8H3QO)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 24208-537-25	1 in 1 CARTON	12/22/2017
1		7.5 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
2	NDC: 24208-537-08	1 in 1 CARTON	12/22/2017
2		2.5 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
3	NDC: 24208-537-99	1 in 1 CARTON	12/22/2017
3		2.5 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
4	NDC: 24208-537-75	1 in 1 CARTON	12/22/2017
4		7.5 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
5	NDC: 24208-537-10	1 in 1 CARTON	05/01/2019
5		0.4 mL in 1 AMPULE; Type 0: Not a Combination Product
6	NDC: 24208-537-01	1 in 1 CARTON	05/01/2019
6		0.4 mL in 1 AMPULE; Type 0: Not a Combination Product
7	NDC: 24208-537-15	2 in 1 CARTON	04/30/2019
7		7.5 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA208144	12/22/2017

Labeler - Bausch & Lomb Incorporated (196603781)

Establishment
Name	Address	ID/FEI	Business Operations
Bausch & Lomb Incorporated		079587625	MANUFACTURE(24208-537)

Establishment
Name	Address	ID/FEI	Business Operations
Laboratoire Unither		574139809	MANUFACTURE(24208-537)