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FDA Approval

LUMIFY PRESERVATIVE FREE EYE DROPS

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Effective Date
May 27, 2025
Labeling Type
HUMAN OTC DRUG LABEL
Brimonidine(0.25 mg in 1 mL)

Manufacturing Establishments2

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Bausch & Lomb Incorporated

Bausch & Lomb Incorporated

079587625

Laboratoire Unither

Bausch & Lomb Incorporated

574139809

Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

LUMIFY PRESERVATIVE FREE EYE DROPS

Product Details

NDC Product Code
24208-538
Application Number
NDA218424
Marketing Category
NDA (C73594)
Route of Administration
OPHTHALMIC
Effective Date
May 27, 2025
BORIC ACIDInactive
Code: R57ZHV85D4Class: IACT
CALCIUM CHLORIDEInactive
Code: M4I0D6VV5MClass: IACT
GLYCERINInactive
Code: PDC6A3C0OXClass: IACT
SODIUM BORATEInactive
Code: 91MBZ8H3QOClass: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
POTASSIUM CHLORIDEInactive
Code: 660YQ98I10Class: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
Code: 4S9CL2DY2HClass: ACTIBQuantity: 0.25 mg in 1 mL

Drug Labeling Information

Complete FDA-approved labeling information including indications, dosage, warnings, contraindications, and other essential prescribing details.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package/Label Principal Display Panel- 20 ct Carton

BAUSCH + LOMB

NDC 24208-538-20

NEW

[Eye Image]

LUMIFY**®**

PRESERVATIVE FREE

BRIMONIDINE TARTRATE
OPHTHALMIC SOLUTION 0.025%
REDNESS RELIEVER EYE DROPS

*Now available in preservative free *Works in 1 minute *Convenient single-use vials

20 single-use vials (4 pouches x 5 single-use vials)

0.013 FL OZ (0.4 mL) per vial

[vial icon]
Sterile

622309
3912000

carton


INDICATIONS & USAGE SECTION

Use

  • relieves redness of the eye due to minor eye irritations

DOSAGE & ADMINISTRATION SECTION

Directions

  • adults and children 5 years of age and over:
    • twist tab completely off to open vial
    • instill 1 drop in the affected eye(s)
    • discard vial immediately after use; do not re-use
    • store unused single-use vials in the child-resistant carton
    • 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
  • children under 5 years of age: consult a doctor

WARNINGS SECTION

Warnings

For external use only


OTC - ACTIVE INGREDIENT SECTION

Active ingredient

Brimonidine tartrate (0.025%)

OTC - PURPOSE SECTION

Purpose

Redness reliever

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away


SPL UNCLASSIFIED SECTION

Questions or comments?[phone icon] call: 1-800-553-5340

INACTIVE INGREDIENT SECTION

Inactive Ingredients

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.


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