Drug Facts

Drug Facts
SPL v15
SPL
SPL Set ID 022de945-0b26-40ae-8e88-d3fe2464d106
Route
OPHTHALMIC
Published
Effective Date 2023-11-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Brimonidine (0.25 mg)
Inactive Ingredients
Benzalkonium Chloride Boric Acid Calcium Chloride Glycerin Potassium Chloride Sodium Borate Sodium Chloride Water

Identifiers & Packaging

Marketing Status
NDA Active Since 2017-12-22

Description

Brimonidine tartrate (0.025%)

Purpose

Redness reliever


Medication Information

Purpose

Redness reliever

Description

Brimonidine tartrate (0.025%)

Use
  • relieves redness of the eye due to minor eye irritations
Section 50565-1

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

Warnings

For external use only

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
Do Not Use
  • if solution changes color or becomes cloudy
Active Ingredient

Brimonidine tartrate (0.025%)

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?

[phone icon] Call: 1-800-553-5340

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
Principal Display Panel 7.5 Ml Carton

BAUSCH + LOMB

LARGE SIZE

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)

AB53708

3911700


Structured Label Content

Use
  • relieves redness of the eye due to minor eye irritations
Section 50565-1 (50565-1)

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

Purpose

Redness reliever

Warnings

For external use only

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
Do Not Use (Do not use)
  • if solution changes color or becomes cloudy
Active Ingredient (Active ingredient)

Brimonidine tartrate (0.025%)

Other Information (Other information)
  • store at 15-25°C (59-77°F)
Inactive Ingredients (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? (Questions or comments?)

[phone icon] Call: 1-800-553-5340

Stop Use and Ask A Doctor If (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
Principal Display Panel 7.5 Ml Carton (PRINCIPAL DISPLAY PANEL - 7.5 mL Carton)

BAUSCH + LOMB

LARGE SIZE

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)

AB53708

3911700


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)