FDA.reportPublic FDA data

Refill Bundle 7 Large Office

Manufacturer
CMC Group, Inc.
Effective date
2025-01-13
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:52:35

Label at a glance#

ProductRefill Bundle 7 Large Office
Active ingredientBENZALKONIUM CHLORIDE
Label structure7 sections

Dosage and administration

Tear open packet, unfold towelette and use to cleanse desired skin area. Discard towelette appropriately after single use.

Label contents#

Full prescribing information#

Active Ingredient:

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.13%

Purpose:

OTC - PURPOSE SECTION

First Aid Antiseptic

Use:

INDICATIONS & USAGE SECTION

For Professional and Hospital use. Helps prevent infection. Antiseptic cleansing of face, hands and body without soap and water.

Warnings:

WARNINGS SECTION

For external use only.

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. If unusual redness, swelling or other symptoms occur, consult a physician immediately.

Do not use:

OTC - DO NOT USE SECTION

In the eyes, or over large areas of the body.

Directions:

DOSAGE & ADMINISTRATION SECTION

Tear open packet, unfold towelette and use to cleanse desired skin area. Discard towelette appropriately after single use.

Inactive ingredient:

INACTIVE INGREDIENT SECTION

Purified water.

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Kit3Kit3

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label1Label1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1038558benzalkonium chloride 0.13 % Medicated PadPSN5
1038558benzalkonium chloride 1.3 MG/ML Medicated PadSCD5
1038558benzalkonium chloride 0.13 % Topical ClothSY5
1038558benzalkonium chloride 0.13 % Topical SwabSY5
1038558benzalkonium chloride 0.13 GM per 100 GM Topical PadSY5
1038558benzalkonium chloride 0.13 GM per 100 GM Topical SwabSY5
1038558benzalkonium chloride 1 ML per 750 ML Topical SwabSY5

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49687-0011-1Refill Bundle 7 Large Office0.9 g in 1 PATCHCLOTH9 g0.13 g in 100g5
49687-0011-1Refill Bundle 7 Large Office10 in 1 BOXCLOTH0.13 g in 100g5
49687-0029-0Refill Bundle 7 Large Office1 in 1 KITKIT15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49687-0011REFILL BUNDLE 7 LARGE OFFICE (BENZALKONIUM CHLORIDE) KIT [CMC GROUP, INC.]5Current NDC, Legacy NDC20250115_6620a8f3-098d-d045-e053-2a91aa0a0d94.zip
49687-0029REFILL BUNDLE 7 LARGE OFFICE (BENZALKONIUM CHLORIDE) KIT [CMC GROUP, INC.]5Current NDC, Legacy NDC, 3 package rows20250115_6620a8f3-098d-d045-e053-2a91aa0a0d94.zip

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49687-002949687-0029-0
49687-001149687-0011-1

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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Standard ANSI First AidWATER, BENZALKONIUM CHLORIDE, ISOPROPYL ALCOHOL, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, LIDOCAINE HYDROCHLORIDECMC Group, Inc.e1ef74bf-8895-4200-a411-f726dcdaa9452025-04-02WarningsExact identifier
ndc (package): 49687-0011-1
ndc11 (package): 49687001101
Large ANSI First Aid KitWATER, BENZALKONIUM CHLORIDE, ISOPROPYL ALCOHOL, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, LIDOCAINE HYDROCHLORIDECMC Group, Inc.fa8578c2-a0bc-4e2e-a4f9-d48debfff3782025-04-02WarningsExact identifier
ndc (package): 49687-0011-1
ndc11 (package): 49687001101
Antiseptic TowelettesBENZALKONIUM CHLORIDECMC Group Inc.d7470f98-4278-415b-92e7-9eca2036bc092025-01-13WarningsExact identifier
ndc (package): 49687-0011-1
ndc (product): 49687-0011
ndc11 (package): 49687001101
Refill Bundle 7 Large OfficeBENZALKONIUM CHLORIDECMC Group, Inc.6620a8f3-098d-d045-e053-2a91aa0a0d942025-01-13WarningsExact identifier
ndc (package): 49687-0011-1
ndc (package): 49687-0029-0
ndc (product): 49687-0029
ndc11 (package): 49687002900
ndc11 (package): 49687001101
spl id: 2b9ba201-39ef-1894-e063-6294a90ad510
spl set id: 6620a8f3-098d-d045-e053-2a91aa0a0d94
Refill 2BENZALKONIUM CHLORIDE, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATECMC Group, Inc.45dde3f0-546c-4ec5-beb0-c3d0432f49832025-01-13WarningsExact identifier
ndc (package): 49687-0011-1
ndc11 (package): 49687001101

Reported adverse events (FAERS/openFDA)#

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