FDA.reportPublic FDA data

Sunmark Redness Relief

Manufacturer
Strategic Sourcing Services LLC | KC Pharmaceuticals, Inc.
Effective date
2019-10-23
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-02 00:06:27

Label at a glance#

ProductSunmark Redness Relief
Active ingredientGLYCERIN, NAPHAZOLINE HYDROCHLORIDE
Label structure8 sections

Indications and uses

relieves redness of the eye due to minor eye irritations for use as a protectant against further irritation or to relieve dryness of the eye temporarily relieves burning and irritation due to dryness of the eye

Dosage and administration

Instill 1 or 2 drops in the affected eye(s) up to 4 times daily

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Glycerin 0.2%

Naphazoline hydrochloride 0.012%

Purpose

OTC - PURPOSE SECTION

Lubricant and redness reliver

Uses

INDICATIONS & USAGE SECTION

  • relieves redness of the eye due to minor eye irritations
  • for use as a protectant against further irritation or to relieve dryness of the eye
  • temporarily relieves burning and irritation due to dryness of the eye

Warnings

WARNINGS SECTION

For external use only

Do not use this product if

OTC - DO NOT USE SECTION

  • solution changes color or become cloudy

Ask a doctor before use

OTC - ASK DOCTOR SECTION

if you have narrow angle glaucoma

when using this product

OTC - WHEN USING SECTION

  • do not touch tip of container to any surface to avoid contamination
  • replace cap after using
  • overuse may cause more redness of the eye
  • pupils may become enlarged temporarily

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • you feel eye pain
  • changes in vision occur
  • redness or irritation of the eye lasts
  • condition worsens
  • symptoms last 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 or 2 drops in the affected eye(s) up to 4 times daily

Other information

OTHER SAFETY INFORMATION

  • Tamper Evident. Do not use this product if imprinted neckband is missing or broken.
  • store at room temperature
  • remove contact lenses before using

Inactive ingredients

INACTIVE INGREDIENT SECTION

benzalkonium chloride, boric acid, edetate disodium, purified water, sodium borate

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CartonCarton

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49348-894-29ML - Milliliter49348-89402858ca8-08b8-4327-a73c-855c5f2a91ed12014-10-03

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49348-89449348-894-29

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZALKONIUM CHLORIDEF5UM2KM3W7IACT
BORIC ACIDR57ZHV85D4IACT
EDETATE DISODIUM7FLD91C86KIACT
WATER059QF0KO0RIACT
SODIUM BORATE91MBZ8H3QOIACT
GLYCERINPDC6A3C0OXACTIB
NAPHAZOLINE HYDROCHLORIDEMZ1131787DACTIB

Source Document#

Source XML

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
efb8b41e-52b3-2c68-e053-2995a90ae9e547fc9b82-6920-4bee-a34d-2658ddee6ca32022-12-13WarningsExact identifier
spl set id: 47fc9b82-6920-4bee-a34d-2658ddee6ca3

Reported adverse events (FAERS/openFDA)#

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