FDA.reportPublic FDA data

Refill 2

Manufacturer
CMC Group, Inc.
Effective date
2025-01-13
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
full-release
Hydrated at
2026-06-01 00:52:34

Label at a glance#

ProductRefill 2
Active ingredientBENZALKONIUM CHLORIDE, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, BACITRACIN ZINC
Label structure13 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.

Active ingredients (in each gram)

OTC - ACTIVE INGREDIENT SECTION

Bacitracin zinc (bacitracin 400 units) Neomycin sulfate (neomycin 3.5mg) Polymyxin B sulfate (polymyxin B 5,000 units)

Purpose

OTC - PURPOSE SECTION

First aid antibiotic

Use

INDICATIONS & USAGE SECTION

  • First aid to help prevent infection in minor cuts, scrapes, and burns.

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

• in the eyes • over large areas of the body • if you are allergic to any of the ingredient • longer than 1 week unless directed by a doctor.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

• deep or punture wounds • animal bites • serious burns.

Stop use and ask a doctor if

OTC - STOP USE SECTION

• the condition persists or gets worse • a rash or other allergic reaction develops.

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

• Clean the affected area. • Apply a small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily. • May be covered with a sterile bandage.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Mineral oil, petrolatum, purified water

Antiseptic Towelettes (49687-0016-0) Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TowelettesTowelettes

Antibiotic Application (49687-0013-0) Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Antibiotic ApplicationAntibiotic Application

Refill 2 (49687-0016-0) Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Refill 2Refill 2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
204602bacitracin 400 UNT / neomycin 3.5 MG / polymyxin B 5000 UNT per GM Topical OintmentPSN9
1038558benzalkonium chloride 0.13 % Medicated PadPSN9
204602bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG Topical OintmentSCD9
1038558benzalkonium chloride 1.3 MG/ML Medicated PadSCD9
204602bacitracin 400 UNT / neomycin 3.5 MG (as neomycin sulfate 5 MG) / polymyxin B 5000 UNT per GM Topical OintmentSY9
1038558benzalkonium chloride 0.13 % Topical ClothSY9
1038558benzalkonium chloride 0.13 % Topical SwabSY9
1038558benzalkonium chloride 0.13 GM per 100 GM Topical PadSY9
1038558benzalkonium chloride 0.13 GM per 100 GM Topical SwabSY9
1038558benzalkonium chloride 1 ML per 750 ML Topical SwabSY9

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
BACITRACIN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
NEOMYCIN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
POLYMYXIN B Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
99e684e6-f435-feb8-d2bb-3a546f1cb768Product name220161117
25340b3b-3e4c-4ff8-abf6-3e62ec46bd0cProduct name120160603
2d352c73-a357-4193-a4de-dfdf9a2ac8e4Product name120150819
b045ad64-0f28-9a02-2f9b-b34d94fb2278Product name120140508
b6082387-f592-1148-0844-bd068fd213fbProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49687-0011-1Refill 20.9 g in 1 PATCHCLOTH18 g0.13 g in 100g9
49687-0011-1Refill 210 in 1 BOXCLOTH0.13 g in 100g9
49687-0016-0Refill 21 in 1 KITKIT19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49687-0011REFILL 2 (BENZALKONIUM CHLORIDE, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE) KIT [CMC GROUP, INC.]9Current NDC, Legacy NDC20250115_45dde3f0-546c-4ec5-beb0-c3d0432f4983.zip
49687-0013REFILL 2 (BENZALKONIUM CHLORIDE, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE) KIT [CMC GROUP, INC.]9Current NDC, Legacy NDC20250115_45dde3f0-546c-4ec5-beb0-c3d0432f4983.zip
49687-0016REFILL 2 (BENZALKONIUM CHLORIDE, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE) KIT [CMC GROUP, INC.]9Current NDC, Legacy NDC, 3 package rows20250115_45dde3f0-546c-4ec5-beb0-c3d0432f4983.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49687-001649687-0016-0
49687-001149687-0011-1
49687-001349687-0013-0

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
NEOMYCIN SULFATE057Y626693ACTIM
POLYMYXIN B SULFATE19371312D4ACTIM
MINERAL OILT5L8T28FGPIACT
PETROLATUM4T6H12BN9UIACT
WATER059QF0KO0RIACT
BACITRACIN ZINC89Y4M234ESACTIM

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 · 6 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
ndc (package): 49687-0013-0
ndc11 (package): 49687001300
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
ndc (package): 49687-0013-0
ndc11 (package): 49687001300
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
Antibiotic ApplicationBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATECMC Group, Inc.da436c35-a98f-4df7-9d23-885564734cef2025-01-13WarningsExact identifier
ndc (package): 49687-0013-0
ndc (product): 49687-0013
ndc11 (package): 49687001300
Refill Bundle 7 Large OfficeBENZALKONIUM CHLORIDECMC Group, Inc.6620a8f3-098d-d045-e053-2a91aa0a0d942025-01-13WarningsExact identifier
ndc (package): 49687-0011-1
ndc11 (package): 49687001101
Refill 2BENZALKONIUM CHLORIDE, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATECMC Group, Inc.45dde3f0-546c-4ec5-beb0-c3d0432f49832025-01-13WarningsExact identifier
ndc (package): 49687-0016-0
ndc (package): 49687-0011-1
ndc (package): 49687-0013-0
ndc (product): 49687-0016
ndc11 (package): 49687001300
ndc11 (package): 49687001600
ndc11 (package): 49687001101
spl id: 2b9bdbfb-4d04-099d-e063-6394a90a39f5
spl set id: 45dde3f0-546c-4ec5-beb0-c3d0432f4983

Reported adverse events (FAERS/openFDA)#

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