FDA.reportPublic FDA data

Advanced Eye Relief/ Redness Maximum Relief

Manufacturer
Bausch & Lomb Incorporated
Effective date
2024-09-25
Label type
HUMAN OTC DRUG LABEL
Version
11
Source
full-release
Hydrated at
2026-06-01 00:22:04

Label at a glance#

ProductAdvanced Eye Relief/ Redness Maximum Relief
Active ingredientHYPROMELLOSE, UNSPECIFIED, NAPHAZOLINE HYDROCHLORIDE
Label structure9 sections

Indications and uses

temporary relief of redness and discomfort due to: minor eye irritations exposure to wind or sun dryness of the eye prevents further irritation

Dosage and administration

instill 1 to 2 drops in the affected eye(s) up to four times daily

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Hypromellose (0.5%)
Naphazoline hydrochloride (0.03%)

Purpose

OTC - PURPOSE SECTION

Lubricant
Redness reliever

Uses

INDICATIONS & USAGE SECTION

  • temporary relief of redness and discomfort due to:
    • minor eye irritations
    • exposure to wind or sun
    • dryness of the eye
  • prevents further irritation

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

  • if solution changes color or becomes cloudy

Ask a doctor before use if you have

OTC - ASK DOCTOR/PHARMACIST SECTION

  • narrow angle glaucoma

When using this product

OTC - WHEN USING SECTION

  • do not touch tip of container to any surface to avoid contamination
  • do not overuse as it may produce increased redness of the eye
  • pupils may become enlarged temporarily
  • remove contact lenses before using
  • replace cap after use

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • you experience eye pain, changes in vision, continued redness or irritation of the eye
  • condition worsens or persists for more than 72 hours

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • instill 1 to 2 drops in the affected eye(s) up to four times daily

Other information

SPL UNCLASSIFIED SECTION

  • store at 15–25 °C (59–77 °F)
  • keep tightly closed
  • use before expiration date marked on the carton and bottle

Inactive ingredients

INACTIVE INGREDIENT SECTION

benzalkonium chloride, boric acid, edetate disodium, sodium borate, sodium chloride, water for injection. Hydrochloric acid and/or sodium hydroxide may be used to adjust pH.

Questions or comments?

OTC - QUESTIONS SECTION

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

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

carton
carton

BAUSCH + LOMB
ADVANCED
Eye Relief ®
Maximum
Redness
REDNESS RELIEVER/
LUBRICANT EYE DROPS

  • Maximum strength
    redness reliever
  • Moisturizes and
    comforts

STERILE 0.5 FL OZ (15 mL)

3843903
AB55411A

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1046654hypromellose 0.5 % / naphazoline HCl 0.03 % Ophthalmic SolutionPSN11
1046654hypromellose 5 MG/ML / naphazoline hydrochloride 0.3 MG/ML Ophthalmic SolutionSCD11
1046654hypromellose 0.5 % / naphazoline hydrochloride 0.03 % Ophthalmic SolutionSY11

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e18001c8-33ae-5f66-9cdc-a39724bd4573Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
24208-450-15Advanced Eye Relief/ Redness Maximum Relief15 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS1511
24208-450-15Advanced Eye Relief/ Redness Maximum Relief1 in 1 CARTONSOLUTION/ DROPS111
24208-450-90Advanced Eye Relief/ Redness Maximum Relief2 in 1 CARTONSOLUTION/ DROPS211
24208-450-90Advanced Eye Relief/ Redness Maximum Relief15 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS1511

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24208-450ADVANCED EYE RELIEF/ REDNESS MAXIMUM RELIEF (NAPHAZOLINE HYDROCHLORIDE AND HYPROMELLOSE) SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]11Current NDC, Legacy NDC, 4 package rows20240927_3c11285a-7e86-4b47-b1ee-e7d59858087d.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
HYPROMELLOSESACTIVE INGREDIENT3NXW29V3WO2
NAPHAZOLINE HYDROCHLORIDEACTIVE INGREDIENTMZ1131787D2
HYPROMELLOSESACTIVE MOIETY3NXW29V3WO2
NAPHAZOLINEACTIVE MOIETYH231GF11BV2
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W72
BORIC ACIDINACTIVE INGREDIENTR57ZHV85D42
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86K2
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CB2
SODIUM BORATEINACTIVE INGREDIENT91MBZ8H3QO2
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8X2
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32I2
WATERINACTIVE INGREDIENT059QF0KO0R2

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
24208-45024208-450-15, 24208-450-90

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZALKONIUM CHLORIDEF5UM2KM3W7IACT
BORIC ACIDR57ZHV85D4IACT
EDETATE DISODIUM7FLD91C86KIACT
WATER059QF0KO0RIACT
SODIUM BORATE91MBZ8H3QOIACT
SODIUM CHLORIDE451W47IQ8XIACT
HYDROCHLORIC ACIDQTT17582CBIACT
SODIUM HYDROXIDE55X04QC32IIACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOACTIB
NAPHAZOLINE HYDROCHLORIDEMZ1131787DACTIB

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 21 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7SOLUTION/ DROPS / OPHTHALMIC1 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSOLUTION/ DROPS / OPHTHALMIC0.13 %w/vExact identifier — unii+route+dosage form
3 equally ranked IID candidates
SODIUM BORATESODIUM BORATE91MBZ8H3QOSOLUTION/ DROPS / OPHTHALMIC1.1 %w/vExact identifier — unii+route+dosage form
3 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSOLUTION/ DROPS / OPHTHALMIC0.13 %w/vExact identifier — unii+route+dosage form
3 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISOLUTION/ DROPS / OPHTHALMICADJ PHExact identifier — unii+route+dosage form
3 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBSOLUTION/ DROPS / OPHTHALMICADJ PHExact identifier — unii+route+dosage form
3 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISOLUTION/ DROPS / OPHTHALMICADJ PHExact identifier — unii+route+dosage form
3 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBSOLUTION/ DROPS / OPHTHALMICADJ PHExact identifier — unii+route+dosage form
3 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISOLUTION/ DROPS / OPHTHALMICADJ PHExact identifier — unii+route+dosage form
3 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSOLUTION/ DROPS / OPHTHALMIC55 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
BORIC ACIDBORIC ACIDR57ZHV85D4SOLUTION/ DROPS / OPHTHALMIC48 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
BORIC ACIDBORIC ACIDR57ZHV85D4SOLUTION/ DROPS / OPHTHALMIC48 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
SODIUM BORATESODIUM BORATE91MBZ8H3QOSOLUTION/ DROPS / OPHTHALMIC1.1 %w/vExact identifier — unii+route+dosage form
3 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSOLUTION/ DROPS / OPHTHALMIC0.13 %w/vExact identifier — unii+route+dosage form
3 equally ranked IID candidates
BORIC ACIDBORIC ACIDR57ZHV85D4SOLUTION/ DROPS / OPHTHALMIC48 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7SOLUTION/ DROPS / OPHTHALMIC1 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSOLUTION/ DROPS / OPHTHALMIC55 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSOLUTION/ DROPS / OPHTHALMIC55 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBSOLUTION/ DROPS / OPHTHALMICADJ PHExact identifier — unii+route+dosage form
3 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7SOLUTION/ DROPS / OPHTHALMIC1 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
SODIUM BORATESODIUM BORATE91MBZ8H3QOSOLUTION/ DROPS / OPHTHALMIC1.1 %w/vExact identifier — unii+route+dosage form
3 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Advanced Eye Relief/ Redness Maximum ReliefNAPHAZOLINE HYDROCHLORIDE AND HYPROMELLOSEBausch & Lomb Incorporated3c11285a-7e86-4b47-b1ee-e7d59858087d2024-09-25WarningsExact identifier
ndc (package): 24208-450-15
ndc (package): 24208-450-90
ndc (product): 24208-450
ndc11 (package): 24208045090
ndc11 (package): 24208045015
spl id: 22f543dc-1475-ff56-e063-6394a90a867b
spl set id: 3c11285a-7e86-4b47-b1ee-e7d59858087d

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.