FDA.reportPublic FDA data

Coralite ANTIBACTERIAL BANDAGE

Manufacturer
UNITED EXCHANGE CORP | Planet (Suzhou) Medical Products Co., Ltd.
Effective date
2019-09-25
Label type
HUMAN OTC DRUG LABEL
Version
100
Source
legacy-cache
Hydrated at
2026-08-02 00:09:15

Label at a glance#

ProductCoralite ANTIBACTERIAL BANDAGE
Active ingredientBENZALKONIUM CHLORIDE
Label structure8 sections

Indications and uses

First aid to help reduce the risk of infection in minor cuts, scrapes, and burns.

Dosage and administration

Clean and dry the affected area. Apply a sterile bandage on the area 1 to 3 times daily.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.12%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

First aid to help reduce the risk of infection in minor cuts, scrapes, and burns.

Warnings

WARNINGS SECTION

For external use only.

OTC - STOP USE SECTION

Stop use and consult a doctor if the condition persists or gets worse.

Do not use

  • longer than one week unless directed by a physician. In case of deep or puncture wounds,  animal bites, or serious burn, consult a physician.
  • longer than 1 week unless directed by a doctor.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

Clean and dry the affected area. Apply a sterile bandage on the area 1 to 3 times daily.

Other Information

SPL UNCLASSIFIED SECTION

Not intended for use on delicate or sensitive skin.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

none

Coralite ANTIBACTERIAL BANDAGE WITH NON STICK PAD 30 count (65923-001-00)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

AntibacterialBandage
AntibacterialBandage

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
BENZALKONIUM CHLORIDEACTIVE INGREDIENTF5UM2KM3W71
BENZALKONIUMACTIVE MOIETY7N6JUD5X6Y1

Products#

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

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
65923-00165923-001-00

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB

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
93628989-adbd-97a5-e053-2995a90ab7e47736c2c9-8594-4669-98c8-0f028f455d2a2019-09-25WarningsExact identifier
spl id: 93628989-adbd-97a5-e053-2995a90ab7e4
spl set id: 7736c2c9-8594-4669-98c8-0f028f455d2a

Reported adverse events (FAERS/openFDA)#

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