61010-5701, First Aid and Burn Cream

Manufacturer
Safetec of America, Inc.
Effective date
2024-02-07
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:08:24

Label at a glance#

ProductFirst Aid and Burn
Active ingredientBENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE
Label structure10 sections

Indications and uses

temporary relief of pain associated with minor burns helps protect against harmful bacteria

Dosage and administration

clean affected area apply small amount not more than 3 times daily children under 2: consult a doctor

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.13%

Lidocaine HCl 0.5%

Purpose

OTC - PURPOSE SECTION

First Aid Antiseptic

Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

  • temporary relief of pain associated with minor burns
  • helps protect against harmful bacteria

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

  • in eyes
  • in large quantities
  • over raw or blistered areas, or on deep puncture wounds, animal bites, serious burns
  • for more than one week unless directed by a doctor

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If ingested contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • clean affected area
  • apply small amount not more than 3 times daily
  • children under 2: consult a doctor

Inactive ingredients

INACTIVE INGREDIENT SECTION

aloe vera, emulsifying wax, ethyl alcohol, methylparaben, mineral oil, paraffin, propylparaben, purified water, white petrolatum, white wax

PRINCIPAL DISPLAY PANEL – 0.9 gram packet

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 61010-5701-03

Safetec

First Aid &
Burn Cream

0.9 g (1/32 oz.)

Safetec of America, Inc.
Buffalo, NY 14215
800-456-7077

PRINCIPAL DISPLAY PANEL – 0.9 gram packet
PRINCIPAL DISPLAY PANEL – 0.9 gram packet

PRINCIPAL DISPLAY PANEL – 144 count box

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 61010-5701-4

Safetec

First Aid

First Aid & Burn Cream

  • For Temporary Relief of
    Pain Associated with
    Minor Burns
  • Helps Protect Against
    Harmful Bacteria

Reorder No. 53410
To reorder:
Call: 1-800-456-7077
Fax: 716-895-2969
Online: www.safetec.com

PRINCIPAL DISPLAY PANEL – 144 count box
PRINCIPAL DISPLAY PANEL – 144 count box

Principal Display Panel – 10 Packet Box Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Safetec ®

FIRST AID

Burn Cream

Quickly soothes pain caused by minor burns
and protects against infection

10 Packets

Each Packet Net. Wt. 0.9g

Made in USA

Reorder No. 53408

Principal Display Panel – 10 Packet Box Label
Principal Display Panel – 10 Packet Box Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1012100benzalkonium chloride 0.13 % / lidocaine HCl 0.5 % Topical CreamPSN5
1012100benzalkonium chloride 1.3 MG/ML / lidocaine hydrochloride 5 MG/ML Topical CreamSCD5
1012100benzalkonium chloride 0.13 % / lidocaine hydrochloride 0.5 % Topical CreamSY5

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
LIDOCAINE 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
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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61010-5701-3First Aid and Burn0.9 g in 1 PACKETCREAM0.95
61010-5701-4First Aid and Burn144 in 1 BOXCREAM1445
61010-5701-5First Aid and Burn25 in 1 BOXCREAM255
61010-5701-6First Aid and Burn10 in 1 BOXCREAM105

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61010-5701FIRST AID AND BURN (BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE) CREAM [SAFETEC OF AMERICA, INC.]5Current NDC, Legacy NDC, 4 package rows20240208_47cb6921-5d82-4123-a9e0-0b05d4dcb5b2.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
benzalkonium chlorideACTIVE INGREDIENTF5UM2KM3W71
lidocaine hydrochlorideACTIVE INGREDIENTV13007Z41A1
benzalkoniumACTIVE MOIETY7N6JUD5X6Y1
lidocaineACTIVE MOIETY98PI2009871
alcoholINACTIVE INGREDIENT3K9958V90M1
aloe vera leafINACTIVE INGREDIENTZY81Z83H0X1
methylparabenINACTIVE INGREDIENTA2I8C7HI9T1
mineral oilINACTIVE INGREDIENTT5L8T28FGP1
paraffinINACTIVE INGREDIENTI9O0E3H2ZE1
petrolatumINACTIVE INGREDIENT4T6H12BN9U1
propylparabenINACTIVE INGREDIENTZ8IX2SC1OH1
waterINACTIVE INGREDIENT059QF0KO0R1
white waxINACTIVE INGREDIENT7G1J5DA97F1

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
61010-570161010-5701-3, 61010-5701-4, 61010-5701-5, 61010-5701-6

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 2 · 85 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
methylparabenMETHYLPARABENA2I8C7HI9TCREAM / TOPICAL3000 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
alcoholALCOHOL3K9958V90MAEROSOL / TOPICAL561 mgExact identifier — unii+route
55 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSWAB / TOPICAL2250 mgExact identifier — unii+route
55 equally ranked IID candidates
white waxWHITE WAX7G1J5DA97FCREAM / TOPICAL500 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSWAB / TOPICAL2250 mgExact identifier — unii+route
55 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9UCREAM / TOPICAL4213 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
propylparabenPROPYLPARABENZ8IX2SC1OHCREAM / TOPICAL6 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
alcoholALCOHOL3K9958V90MPOWDER, FOR SOLUTION / TOPICAL40 %w/wExact identifier — unii+route
55 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TCREAM / TOPICAL3000 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
alcoholALCOHOL3K9958V90MAEROSOL / TOPICAL561 mgExact identifier — unii+route
55 equally ranked IID candidates
alcoholALCOHOL3K9958V90MLOTION / TOPICAL25 %w/wExact identifier — unii+route
55 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TCREAM / TOPICAL3000 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
alcoholALCOHOL3K9958V90MAEROSOL, SPRAY / TOPICAL561 mgExact identifier — unii+route
55 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSPRAY / TOPICAL3633 mgExact identifier — unii+route
55 equally ranked IID candidates
alcoholALCOHOL3K9958V90MPOWDER, FOR SOLUTION / TOPICAL40 %w/wExact identifier — unii+route
55 equally ranked IID candidates
alcoholALCOHOL3K9958V90MAEROSOL / TOPICAL561 mgExact identifier — unii+route
55 equally ranked IID candidates
white waxWHITE WAX7G1J5DA97FCREAM / TOPICAL500 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
alcoholALCOHOL3K9958V90MGEL / TOPICAL9971 mgExact identifier — unii+route
55 equally ranked IID candidates
white waxWHITE WAX7G1J5DA97FCREAM / TOPICAL500 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
mineral oilMINERAL OILT5L8T28FGPCREAM / TOPICAL2772 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
alcoholALCOHOL3K9958V90MLOTION / TOPICAL25 %w/wExact identifier — unii+route
55 equally ranked IID candidates
alcoholALCOHOL3K9958V90MGEL, METERED / TOPICAL541 mgExact identifier — unii+route
55 equally ranked IID candidates
mineral oilMINERAL OILT5L8T28FGPCREAM / TOPICAL2772 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSWAB / TOPICAL2250 mgExact identifier — unii+route
55 equally ranked IID candidates
alcoholALCOHOL3K9958V90MAEROSOL, FOAM / TOPICAL4504 mgExact identifier — unii+route
55 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSPRAY / TOPICAL3633 mgExact identifier — unii+route
55 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSPRAY / TOPICAL3633 mgExact identifier — unii+route
55 equally ranked IID candidates
alcoholALCOHOL3K9958V90MAEROSOL, FOAM / TOPICAL4504 mgExact identifier — unii+route
55 equally ranked IID candidates
alcoholALCOHOL3K9958V90MAEROSOL / TOPICAL561 mgExact identifier — unii+route
55 equally ranked IID candidates
paraffinPARAFFINI9O0E3H2ZECREAM / TOPICAL300 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TCREAM / TOPICAL3000 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
alcoholALCOHOL3K9958V90MAEROSOL, SPRAY / TOPICAL561 mgExact identifier — unii+route
55 equally ranked IID candidates
paraffinPARAFFINI9O0E3H2ZECREAM / TOPICAL300 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9UCREAM / TOPICAL4213 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
white waxWHITE WAX7G1J5DA97FCREAM / TOPICAL500 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSOLUTION / TOPICAL2445 mgExact identifier — unii+route
55 equally ranked IID candidates
alcoholALCOHOL3K9958V90MGEL, METERED / TOPICAL541 mgExact identifier — unii+route
55 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSOLUTION / TOPICAL2445 mgExact identifier — unii+route
55 equally ranked IID candidates
white waxWHITE WAX7G1J5DA97FCREAM / TOPICAL500 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSPRAY / TOPICAL3633 mgExact identifier — unii+route
55 equally ranked IID candidates
alcoholALCOHOL3K9958V90MGEL / TOPICAL9971 mgExact identifier — unii+route
55 equally ranked IID candidates
alcoholALCOHOL3K9958V90MLOTION / TOPICAL25 %w/wExact identifier — unii+route
55 equally ranked IID candidates
mineral oilMINERAL OILT5L8T28FGPCREAM / TOPICAL2772 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
alcoholALCOHOL3K9958V90MPOWDER, FOR SOLUTION / TOPICAL40 %w/wExact identifier — unii+route
55 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSHAMPOO / TOPICAL714 mgExact identifier — unii+route
55 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSOLUTION / TOPICAL2445 mgExact identifier — unii+route
55 equally ranked IID candidates
alcoholALCOHOL3K9958V90MAEROSOL, FOAM / TOPICAL4504 mgExact identifier — unii+route
55 equally ranked IID candidates
paraffinPARAFFINI9O0E3H2ZECREAM / TOPICAL300 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSHAMPOO / TOPICAL714 mgExact identifier — unii+route
55 equally ranked IID candidates
alcoholALCOHOL3K9958V90MAEROSOL / TOPICAL561 mgExact identifier — unii+route
55 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSHAMPOO / TOPICAL714 mgExact identifier — unii+route
55 equally ranked IID candidates
alcoholALCOHOL3K9958V90MAEROSOL, SPRAY / TOPICAL561 mgExact identifier — unii+route
55 equally ranked IID candidates
paraffinPARAFFINI9O0E3H2ZECREAM / TOPICAL300 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSOLUTION / TOPICAL2445 mgExact identifier — unii+route
55 equally ranked IID candidates
alcoholALCOHOL3K9958V90MLOTION / TOPICAL25 %w/wExact identifier — unii+route
55 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSHAMPOO / TOPICAL714 mgExact identifier — unii+route
55 equally ranked IID candidates
mineral oilMINERAL OILT5L8T28FGPCREAM / TOPICAL2772 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
alcoholALCOHOL3K9958V90MGEL, METERED / TOPICAL541 mgExact identifier — unii+route
55 equally ranked IID candidates
alcoholALCOHOL3K9958V90MAEROSOL, SPRAY / TOPICAL561 mgExact identifier — unii+route
55 equally ranked IID candidates
propylparabenPROPYLPARABENZ8IX2SC1OHCREAM / TOPICAL6 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
WalgreensDIPHENHYDRAMINE HYDROCHLORIDE, IBUPROFEN, HYDROCORTISONE, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN-B SULFATE, LIDOCAINE HCL, BENZALKONIUM CHLORIDE, ISOPROPYL ALCOHOL, ETHYL ALCOHOLWalgreen Co.5630f48b-404c-b847-e063-6394a90a8d8e2026-07-09WarningsExact identifier
ndc (package): 61010-5701-3
ndc11 (package): 61010570103
Care ScienceDIPHENHYDRAMINE HYDROCHLORIDE, IBUPROFEN, HYDROCORTISONE, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN-B SULFATE, LIDOCAINE HCL, BENZALKONIUM CHLORIDE, ISOPROPYL ALCOHOL, ETHYL ALCOHOLASO LLC562f2b2c-d234-e491-e063-6294a90a705f2026-07-08WarningsExact identifier
ndc (package): 61010-5701-3
ndc11 (package): 61010570103
First Aid and BurnBENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDESafetec of America, Inc.47cb6921-5d82-4123-a9e0-0b05d4dcb5b22024-02-07WarningsExact identifier
ndc (package): 61010-5701-3
ndc (package): 61010-5701-5
ndc (package): 61010-5701-6
ndc (package): 61010-5701-4
ndc (product): 61010-5701
ndc11 (package): 61010570103
ndc11 (package): 61010570105
ndc11 (package): 61010570104
ndc11 (package): 61010570106
spl id: 10d3fc91-82a0-e8eb-e063-6394a90ae87b
spl set id: 47cb6921-5d82-4123-a9e0-0b05d4dcb5b2

Reported adverse events (FAERS/openFDA)#

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