FDA.reportPublic FDA data

ANTIBACTERIAL BANDAGES

Manufacturer
Guangdong Comfort Medical Products Co., Ltd.
Effective date
2025-03-26
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:58:05

Label at a glance#

ProductANTIBACTERIAL BANDAGES
Active ingredientBENZALKONIUM CHLORIDE
Label structure10 sections

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 0.13%

Purpose

OTC - PURPOSE SECTION

Antiseptic

USE

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.

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

Do not use longer than 1 week unless directed by a physician. In case of deep or puncture wounds, animal bites, or serious burn, consult a physician.

Keep out of reach of children. if swallowed get medical help or contact Poison control Center right away.

Other Information

OTHER SAFETY INFORMATION

Not intended for use on delicate or sensitive skin.

DIRECTIONS

INSTRUCTIONS FOR USE SECTION

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

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

Water

Keep out of reach of children

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.

Dosage and administration

DOSAGE & ADMINISTRATION SECTION

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

Label principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 71584-0111-1

ANTIBACTERIAL BANDAGES

Drug Facts

ACTIVE INGREDIENTS

Benzalkonium Chloride 0.13%

Purpose

Antiseptic

USE

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

WARNINGS For external use only.

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.

Keep out of reach of children. if swallowed get medical help or contact Poison control Center right away.

DIRECTIONS

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

Other Information: not intended for use on delicate or sensitive skin.

INACTIVE INGREDIENT

Water

11

22

33

44

55

66

77

88

e1e1

e2e2

e3e3

e4e4

e5e5

e7e7

e8e8

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1038558benzalkonium chloride 0.13 % Medicated PadPSN4
1038558benzalkonium chloride 1.3 MG/ML Medicated PadSCD4
1038558benzalkonium chloride 0.13 % Topical ClothSY4
1038558benzalkonium chloride 0.13 % Topical SwabSY4
1038558benzalkonium chloride 0.13 GM per 100 GM Topical PadSY4
1038558benzalkonium chloride 0.13 GM per 100 GM Topical SwabSY4
1038558benzalkonium chloride 1 ML per 750 ML Topical SwabSY4

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71584-0111-12024-10-12C16284748780-11030e365-4e59-111a-e063-dadaa90a10e2ANTIBACTERIAL BANDAGES
71584-0111-22024-10-12C16284748780-11030e365-4e59-111a-e063-dadaa90a10e2ANTIBACTERIAL BANDAGES
71584-0111-32024-10-12C16284748780-11030e365-4e59-111a-e063-dadaa90a10e2ANTIBACTERIAL BANDAGES
71584-0111-42024-10-12C16284748780-11030e365-4e59-111a-e063-dadaa90a10e2ANTIBACTERIAL BANDAGES
71584-0111-52024-10-12C16284748780-11030e365-4e59-111a-e063-dadaa90a10e2ANTIBACTERIAL BANDAGES
71584-0111-62024-10-12C16284748780-11030e365-4e59-111a-e063-dadaa90a10e2ANTIBACTERIAL BANDAGES
71584-0111-12024-01-30C16284748780-11030e365-4e59-111a-e063-dadaa90a10e2ANTIBACTERIAL BANDAGES
71584-0111-22024-01-30C16284748780-11030e365-4e59-111a-e063-dadaa90a10e2ANTIBACTERIAL BANDAGES
71584-0111-32024-01-30C16284748780-11030e365-4e59-111a-e063-dadaa90a10e2ANTIBACTERIAL BANDAGES
71584-0111-42024-01-30C16284748780-11030e365-4e59-111a-e063-dadaa90a10e2ANTIBACTERIAL BANDAGES
71584-0111-52024-01-30C16284748780-11030e365-4e59-111a-e063-dadaa90a10e2ANTIBACTERIAL BANDAGES
71584-0111-62024-01-30C16284748780-11030e365-4e59-111a-e063-dadaa90a10e2ANTIBACTERIAL BANDAGES

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71584-0111-1ANTIBACTERIAL BANDAGES0.5 g in 1 POUCHDRESSING0.54
71584-0111-2ANTIBACTERIAL BANDAGES0.5 g in 1 POUCHDRESSING0.54
71584-0111-3ANTIBACTERIAL BANDAGES0.5 g in 1 POUCHDRESSING0.54
71584-0111-4ANTIBACTERIAL BANDAGES0.5 g in 1 POUCHDRESSING0.54
71584-0111-5ANTIBACTERIAL BANDAGES0.5 g in 1 POUCHDRESSING0.54
71584-0111-6ANTIBACTERIAL BANDAGES0.5 g in 1 POUCHDRESSING0.54
71584-0111-7ANTIBACTERIAL BANDAGES0.578 g in 1 POUCHDRESSING0.5784
71584-0111-8ANTIBACTERIAL BANDAGES1.29 g in 1 POUCHDRESSING1.294

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71584-0111ANTIBACTERIAL BANDAGES (BENZALKONIUM CHLORIDE) DRESSING [GUANGDONG COMFORT MEDICAL PRODUCTS CO., LTD.]4Current NDC, Legacy NDC, 8 package rows20250330_da241df2-6153-05e4-e053-2a95a90a0984.zip

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71584-011171584-0111-1, 71584-0111-2, 71584-0111-3, 71584-0111-4, 71584-0111-5, 71584-0111-6, 71584-0111-7, 71584-0111-8

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
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
ANTIBACTERIAL BANDAGESBENZALKONIUM CHLORIDEGuangdong Comfort Medical Products Co., Ltd.da241df2-6153-05e4-e053-2a95a90a09842025-03-26WarningsExact identifier
ndc (package): 71584-0111-4
ndc (package): 71584-0111-7
ndc (package): 71584-0111-6
ndc (package): 71584-0111-2
ndc (package): 71584-0111-3
ndc (package): 71584-0111-8
ndc (package): 71584-0111-1
ndc (package): 71584-0111-5
ndc (product): 71584-0111
ndc11 (package): 71584011105
ndc11 (package): 71584011106
ndc11 (package): 71584011107
ndc11 (package): 71584011103
ndc11 (package): 71584011108
ndc11 (package): 71584011104
ndc11 (package): 71584011101
ndc11 (package): 71584011102
spl id: 310bdb8a-916f-6b80-e063-6394a90a4634
spl set id: da241df2-6153-05e4-e053-2a95a90a0984

Reported adverse events (FAERS/openFDA)#

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