FDA.reportPublic FDA data

Small Cuts and Burns

Manufacturer
Genuine First Aid LLC | GFA Production ( Xiamen) Co., Ltd
Effective date
2010-06-07
Label type
HUMAN OTC DRUG LABEL
Version
10
Source
full-release
Hydrated at
2026-05-31 22:24:42

Label at a glance#

ProductSmall Cuts and Burns
Active ingredientBENZALKONIUM CHLORIDE, LIDOCAINE, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE
Label structure33 sections

Storage and handling

Other Information: Store at room temperature

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients:                            

Benzalkonium Chloride 0.13%

Lidocaine HCL 0.5%

OTC - PURPOSE SECTION

Purpose: First aid antiseptic, external analgesic

Uses: First aid to help prevent infection and for
the temporary relief of pain and itching associated with:
minor cuts, scrapes, burns

WARNINGS SECTION

Warning:  For external use only.

OTC - DO NOT USE SECTION

Do not use:  in eyes, in large quantities, over raw blistered areas,

or on deep puncture wounds, animal bites or serious burns, for more than one week

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

If ingested, contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Directions: Clean affected area, Apply small amount not more than 3 times daily.

May be covered with a sterile bandage.

STORAGE AND HANDLING SECTION

Other Information:

Store at room temperature

DESCRIPTION SECTION

LOT/EXP:                                    Made in CHINA

20130301

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Genuine First Aid Burn Cream

Antiseptic Pain Relief With Aloe

Net Wt 0.9g (1/32 oz)

Manufactured in CHINA for

Genuine First Aid.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BurnCream
BurnCream

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient:                             Purpose

Benzalkonium Chloride 0.40%... First Aid Antiseptic

OTC - PURPOSE SECTION

Use: For Professional and Hospital use.  Helps

prevent infection.  Antiseptic cleansing of face,

hands and body without soap and water.

WARNINGS SECTION

Warning:    For external use only.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION


Keep out of reach of children:  If swallowed, get medical help

or contact a Poison Control Center right away.

OTC - STOP USE SECTION

Stop use if unusual redness, swelling or other symptoms occur.

Consult a physician immediately.

OTC - DO NOT USE SECTION


Do not use in the eyes or over large areas of

the body.

OTC - WHEN USING SECTION

Directions: Tear open packet, unfold towelette

and use to cleanse desired skin area.  Discard

towelette appropriately after single use.


INACTIVE INGREDIENT SECTION

Inactive Ingredient:    Purified water

DESCRIPTION SECTION

LOT/EXP:                                    Made in CHINA

20130301

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Antiseptic Towelette

Genuine First Aid LLC, Clearwater FL 33755

www.GenuineFirstAid.com

GENUINE FIRST AID

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

AntisepticToweletteAntisepticTowelette

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient: .........Bacitracin Zinc 400 units

Neomycin Sulfate 5mg ( equivalent to 3.5 mg Neomycin base)

Polymyxin B Sulfate 5000 units

OTC - PURPOSE SECTION

Uses:  To help prevent infection in:
minor cuts;  scrapes;  burns

WARNINGS SECTION

Warnings:

For external use only.

OTC - DO NOT USE SECTION

Do not use:  in eyes;  over large areas of the body;

If allergic to any of the ingredients;  for more than one week unless directed by a physician.

OTC - STOP USE SECTION

Stop use and consult a doctor:

if the condition persists or gets worse;  a rash or other allergic reaction develops

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

If ingested, contact a Poison

Control Center right away.

OTC - WHEN USING SECTION


Directions: clean affected area;  apply 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

STORAGE AND HANDLING SECTION

Other information:

Store at room temperature.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Genuine Triple Antibiotic

First Aid Ointment

To Help Prevent Infection

Each Gram Contains:

Bacitracin Zinc 400 units

Neomycin Sulfate 5 mg

(equivalent to 3.5 mg

Neomycin base)

 Polymyxin B Sulfate 5000 units

Net Wt. 0.5g ; (1/64 oz)

Manufactured in CHINA for

GENUINE FIRST AID.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

GenuineTripleAntibioticGenuineTripleAntibiotic

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Small Cuts and Burns

10 Adhesive Plastic Bandages 3/4"x3"
10 Junior Plastic Bandages 3/8"x1-1/2"
5 Adhesive Plastic Bandages 1"x3"
1 Knuckle Fabric Bandage
10 Adhesive Spot Bandages 7/8"x7/8"
1 Fingertip Fabric Bandage
1 Elbow/Knee Adhesive Bandage
1 Burn Cream
5 Antiseptic Towelettes
1 Antibiotic Ointment
2 Sterile Gauge Pads 2"x2"
10 Cotton Tipped Applicators


Manufactured in China for:

Genuine First Aid LLC.
600 Cleveland Street
Suite 400
Clearwater FL 33755

www.GenuineFirstAid.com

GENUINE FIRST AID
Copyright 2009 Genuine First Aid LLC.  All rights reserved.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Small Cuts and BurnsSmall Cuts and Burns

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 OintmentPSN10
1012100benzalkonium chloride 0.13 % / lidocaine HCl 0.5 % Topical CreamPSN10
1038561benzalkonium Cl 0.4 % Medicated PadPSN10
204602bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG Topical OintmentSCD10
1012100benzalkonium chloride 1.3 MG/ML / lidocaine hydrochloride 5 MG/ML Topical CreamSCD10
1038561benzalkonium chloride 4 MG/ML Medicated PadSCD10
204602bacitracin 400 UNT / neomycin 3.5 MG (as neomycin sulfate 5 MG) / polymyxin B 5000 UNT per GM Topical OintmentSY10
1012100benzalkonium chloride 0.13 % / lidocaine hydrochloride 0.5 % Topical CreamSY10
1038561benzalkonium chloride 0.4 % Medicated ToweletteSY10
1038561benzalkonium chloride 0.4 % Topical SwabSY10

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
BACITRACIN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
LIDOCAINE 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
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
99e684e6-f435-feb8-d2bb-3a546f1cb768Product name220161117
25340b3b-3e4c-4ff8-abf6-3e62ec46bd0cProduct name120160603
2d352c73-a357-4193-a4de-dfdf9a2ac8e4Product name120150819
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508
b045ad64-0f28-9a02-2f9b-b34d94fb2278Product name120140508
b6082387-f592-1148-0844-bd068fd213fbProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52124-0116-12020-01-31C16284748780-19d75b9d0-f529-f424-e053-dadaa90a57ceSmall Cuts and Burns

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52124-0001-1Small Cuts and Burns0.8 mL in 1 PACKAGELIQUID4 mL0.40 mL in 100mL10
52124-0003-1Small Cuts and Burns0.5 g in 1 TUBEOINTMENT0.5 g5 mg in 1g10
52124-0004-1Small Cuts and Burns0.9 g in 1 PACKAGECREAM0.9 g0.5 g in 100g10
52124-0116-1Small Cuts and Burns1 in 1 KITKIT110

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52124-0001SMALL CUTS AND BURNS (BENZALKONIUM CHLORIDE, LIDOCAINE, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE) KIT [GENUINE FIRST AID LLC]10Legacy NDC20100608_25292d39-7914-4ef1-b6a0-a7ddff8985e5.zip
52124-0003SMALL CUTS AND BURNS (BENZALKONIUM CHLORIDE, LIDOCAINE, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE) KIT [GENUINE FIRST AID LLC]10Legacy NDC20100608_25292d39-7914-4ef1-b6a0-a7ddff8985e5.zip
52124-0004SMALL CUTS AND BURNS (BENZALKONIUM CHLORIDE, LIDOCAINE, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE) KIT [GENUINE FIRST AID LLC]10Legacy NDC20100608_25292d39-7914-4ef1-b6a0-a7ddff8985e5.zip
52124-0116SMALL CUTS AND BURNS (BENZALKONIUM CHLORIDE, LIDOCAINE, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE) KIT [GENUINE FIRST AID LLC]10Legacy NDC, 4 package rows20100608_25292d39-7914-4ef1-b6a0-a7ddff8985e5.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
BACITRACIN ZINCACTIVE INGREDIENT89Y4M234ES10
BENZALKONIUM CHLORIDEACTIVE INGREDIENTF5UM2KM3W710
LIDOCAINEACTIVE INGREDIENT98PI20098710
NEOMYCIN SULFATEACTIVE INGREDIENT057Y62669310
POLYMYXIN B SULFATEACTIVE INGREDIENT19371312D410
BACITRACINACTIVE MOIETY58H6RWO52I10
BENZALKONIUMACTIVE MOIETY7N6JUD5X6Y10
LIDOCAINEACTIVE MOIETY98PI20098710
NEOMYCINACTIVE MOIETYI16QD7X29710
POLYMYXIN BACTIVE MOIETYJ2VZ07J96K10
WATERINACTIVE INGREDIENT059QF0KO0R10

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52124-011652124-0116-1
52124-000452124-0004-1
52124-000152124-0001-1
52124-000352124-0003-1

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 CHLORIDEF5UM2KM3W7ACTIB
LIDOCAINE98PI200987ACTIB
WATER059QF0KO0RIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
BACITRACIN ZINC89Y4M234ESACTIB
NEOMYCIN SULFATE057Y626693ACTIB
POLYMYXIN B SULFATE19371312D4ACTIB

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
27826c7e-54b3-47bb-ab49-d58dac48fb6325292d39-7914-4ef1-b6a0-a7ddff8985e52010-06-07WarningsExact identifier
spl id: 27826c7e-54b3-47bb-ab49-d58dac48fb63
spl set id: 25292d39-7914-4ef1-b6a0-a7ddff8985e5

Reported adverse events (FAERS/openFDA)#

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