61010-5000, Burn Gel

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#

ProductLidocaine Hydrochloride

Active ingredientLIDOCAINE HYDROCHLORIDE

Label structure13 sections

Indications and uses

Temporary pain relief for minor burns

Dosage and administration

for adults and children 2 years and older: apply to affected area not more than 4 times daily children under 2: do not use, consult a doctor

Contacts and useful links#

PhoneLabel contact800-456-7077

PhoneLabel contact716-895-2969

Websitewww.safetec.com

www.safetec.com

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Pain Relief

Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Lidocaine HCl 2.0%

Purpose

OTC - PURPOSE SECTION

Topical pain relief

Uses

INDICATIONS & USAGE SECTION

Temporary pain relief for minor burns

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

In large quantities, particularly over raw or blistered areas
near eyes, if this happens rinse thoroughly with water

OTC - STOP USE SECTION

Stop use and ask doctorif condition worsens or persists for more than 7 days or clears up and occurs again within a few days

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

for adults and children 2 years and older: apply to affected area not more than 4 times daily
children under 2: do not use, consult a doctor

Inactive ingredients

INACTIVE INGREDIENT SECTION

aloe vera, carbomer, germaben II, propylene glycol, purified water, menthol, triethanolamine, vitamin E acetate

PRINCIPAL DISPLAY PANEL – 0.125 oz. packet

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 61010-5000-0

Safetec

Burn Gel

For Temporary
Pain Relief of
Minor Burns

0.125 oz. (3.7 ml)
Reorder no. 50000

Manufactured by
SAFETEC OF AMERICA, Inc.
Buffalo, NY 14215
800-456-7077
www.safetec.com

PRINCIPAL DISPLAY PANEL – 0.125 oz. packet

PRINCIPAL DISPLAY PANEL – 4 oz. bottle

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 61010-5000-1

Safetec

First Aid
Burn Gel

For Temporary
Pain Relief of
Minor Burns

4 fl. oz. (118 ml)
Reorder no. 50001

Principal Display Panel - Pouch label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Safetec

Burn Gel

0.9 g (1/32 oz.)

Safetec of America, Inc.

Buffalo, NY 14215

800-456-7077

Principal Display Panel - 144 Box label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 61010-5000-04

Safetec

First Aid

Burn Gel

For Temporary Pain Relief
of Minor Burns

Reorder No. 50007

To reorder:

Call: 1-800-456-7077

Fax: 716-895-2969

Online: www.safetec.com

Principal Display Panel - 25 Box label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 61010-5000-5

Safetec

First Aid

Burn Gel

For Temporary Pain Relief
of Minor Burns

25 Packets

Each Packet Net. Wt. 0.9gm

Principal Display Panel – 10 Packet Box Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Safetec ^®

First Aid

Burn Gel

Quickly soothes pain
caused by minor burns

10 Packets

Each Packet Net. Wt. 0.9g

Made in USA

Reorder No. 50028

Principal Display Panel – 10 Packet Box Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1011852	lidocaine HCl 2 % Topical Gel	PSN	5
1011852	lidocaine hydrochloride 0.02 MG/MG Topical Gel	SCD	5
1011852	lidocaine hydrochloride 2 % Topical Jelly	SY	5

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
LIDOCAINE Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
070fbed5-7088-434a-a7ce-f2a64d8d40ac	Product name	2	20260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80f	Product name	5	20250819
860a93dc-4863-49cc-b284-6bbe8191bc48	Product name	4	20250214
eaba870a-6a9d-442e-8643-87b3f558a451	Product name	1	20250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86	Product name	1	20230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57	Product name	3	20210602
aed701d5-9c75-dfaf-7154-cde46179faea	Product name	9	20200313
fa8b5901-e681-426f-82fe-54f6d81ec698	Product name	4	20180619
332d03e4-aa24-4b11-841a-02bf41081920	Product name	1	20171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070	Product name	1	20171221
68ed98f8-24c2-44a0-944a-6d36e82ce25a	Product name	1	20141222
1cd42bc2-a430-c72b-636d-991b235fbf80	Product name	1	20140508
49fa150c-f0de-cce7-3d9c-993ed81c5698	Product name	1	20140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ff	Product name	1	20140508
9137811f-f279-8640-5aeb-99fa2145d64d	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
61010-5000-0	2024-02-07	C162847	48780-1	1030e365-5ec2-111a-e063-dadaa90a10e2	61010-5000, Burn Gel
61010-5000-1	2024-02-07	C162847	48780-1	1030e365-5ec2-111a-e063-dadaa90a10e2	61010-5000, Burn Gel
61010-5000-3	2024-02-07	C162847	48780-1	1030e365-5ec2-111a-e063-dadaa90a10e2	61010-5000, Burn Gel
61010-5000-4	2024-02-07	C162847	48780-1	1030e365-5ec2-111a-e063-dadaa90a10e2	61010-5000, Burn Gel
61010-5000-5	2024-02-07	C162847	48780-1	1030e365-5ec2-111a-e063-dadaa90a10e2	61010-5000, Burn Gel
61010-5000-6	2024-02-07	C162847	48780-1	1030e365-5ec2-111a-e063-dadaa90a10e2	61010-5000, Burn Gel
61010-5000-0	2024-01-30	C162847	48780-1	1030e365-5ec2-111a-e063-dadaa90a10e2	61010-5000, Burn Gel
61010-5000-1	2024-01-30	C162847	48780-1	1030e365-5ec2-111a-e063-dadaa90a10e2	61010-5000, Burn Gel
61010-5000-3	2024-01-30	C162847	48780-1	1030e365-5ec2-111a-e063-dadaa90a10e2	61010-5000, Burn Gel
61010-5000-4	2024-01-30	C162847	48780-1	1030e365-5ec2-111a-e063-dadaa90a10e2	61010-5000, Burn Gel
61010-5000-5	2024-01-30	C162847	48780-1	1030e365-5ec2-111a-e063-dadaa90a10e2	61010-5000, Burn Gel
61010-5000-6	2024-01-30	C162847	48780-1	1030e365-5ec2-111a-e063-dadaa90a10e2	61010-5000, Burn Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
61010-5000-0	Lidocaine Hydrochloride	3.3 g in 1 PACKET	GEL	3.3	5
61010-5000-1	Lidocaine Hydrochloride	121.2 g in 1 BOTTLE	GEL	121.2	5
61010-5000-3	Lidocaine Hydrochloride	0.9 g in 1 POUCH	GEL	0.9	5
61010-5000-4	Lidocaine Hydrochloride	144 in 1 CARTON	GEL	144	5
61010-5000-4	Lidocaine Hydrochloride	0.9 g in 1 POUCH	GEL	0.9	5
61010-5000-5	Lidocaine Hydrochloride	0.9 g in 1 POUCH	GEL	0.9	5
61010-5000-5	Lidocaine Hydrochloride	25 in 1 CARTON	GEL	25	5
61010-5000-6	Lidocaine Hydrochloride	0.9 g in 1 PACKET	GEL	0.9	5
61010-5000-6	Lidocaine Hydrochloride	10 in 1 BOX	GEL	10	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61010-5000	LIDOCAINE HYDROCHLORIDE GEL [SAFETEC OF AMERICA, INC.]	5	Current NDC, Legacy NDC, 9 package rows	20240208_1c5eb3b3-79b3-472a-ae36-ec6a7dc72925.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Lidocaine Hydrochloride	ACTIVE INGREDIENT	V13007Z41A	2
Lidocaine	ACTIVE MOIETY	98PI200987	2
.alpha.-tocopherol acetate	INACTIVE INGREDIENT	9E8X80D2L0	2
aloe vera leaf	INACTIVE INGREDIENT	ZY81Z83H0X	2
diazolidinyl urea	INACTIVE INGREDIENT	H5RIZ3MPW4	2
menthol	INACTIVE INGREDIENT	L7T10EIP3A	2
propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	2
trolamine	INACTIVE INGREDIENT	9O3K93S3TK	2
water	INACTIVE INGREDIENT	059QF0KO0R	2

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

Lidocaine Hydrochloride
ALOE VERA LEAF
PROPYLENE GLYCOL
DIAZOLIDINYL UREA
WATER
MENTHOL
.ALPHA.-TOCOPHEROL ACETATE
TROLAMINE
LIDOCAINE
LIDOCAINE HYDROCHLORIDE ANHYDROUS

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
61010-5000	61010-5000-0, 61010-5000-1, 61010-5000-3, 61010-5000-4, 61010-5000-5, 61010-5000-6

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
Name	UNII	Kind
ALOE VERA LEAF	ZY81Z83H0X	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
DIAZOLIDINYL UREA	H5RIZ3MPW4	IACT
WATER	059QF0KO0R	IACT
MENTHOL	L7T10EIP3A	IACT
.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	IACT
TROLAMINE	9O3K93S3TK	IACT
LIDOCAINE HYDROCHLORIDE	V13007Z41A	ACTIR

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 · 63 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
.alpha.-tocopherol acetate	.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	FILM / BUCCAL	0.09 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
trolamine	TROLAMINE	9O3K93S3TK	GEL / TOPICAL		6 mg	Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
trolamine	TROLAMINE	9O3K93S3TK	GEL / TOPICAL		6 mg	Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
diazolidinyl urea	DIAZOLIDINYL UREA	H5RIZ3MPW4	LOTION / TOPICAL	3 %w/w		Exact identifier — unii+route 21 equally ranked IID candidates
.alpha.-tocopherol acetate	.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	CAPSULE / ORAL	2 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
diazolidinyl urea	DIAZOLIDINYL UREA	H5RIZ3MPW4	OINTMENT / TOPICAL	0.1 %w/w		Exact identifier — unii+route 21 equally ranked IID candidates
diazolidinyl urea	DIAZOLIDINYL UREA	H5RIZ3MPW4	CREAM / TOPICAL		29 mg	Exact identifier — unii+route 21 equally ranked IID candidates
menthol	MENTHOL	L7T10EIP3A	GEL / TOPICAL	0.1 %w/w		Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
.alpha.-tocopherol acetate	.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	TABLET / ORAL	0.5 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
diazolidinyl urea	DIAZOLIDINYL UREA	H5RIZ3MPW4	CREAM / TOPICAL		29 mg	Exact identifier — unii+route 21 equally ranked IID candidates
diazolidinyl urea	DIAZOLIDINYL UREA	H5RIZ3MPW4	LOTION / TOPICAL	3 %w/w		Exact identifier — unii+route 21 equally ranked IID candidates
.alpha.-tocopherol acetate	.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	TABLET / ORAL	0.5 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
menthol	MENTHOL	L7T10EIP3A	GEL / TOPICAL	0.1 %w/w		Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
diazolidinyl urea	DIAZOLIDINYL UREA	H5RIZ3MPW4	OINTMENT / TOPICAL	0.1 %w/w		Exact identifier — unii+route 21 equally ranked IID candidates
.alpha.-tocopherol acetate	.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	FILM / BUCCAL	0.09 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
.alpha.-tocopherol acetate	.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	TABLET / ORAL	0.5 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
diazolidinyl urea	DIAZOLIDINYL UREA	H5RIZ3MPW4	LOTION / TOPICAL	3 %w/w		Exact identifier — unii+route 21 equally ranked IID candidates
trolamine	TROLAMINE	9O3K93S3TK	GEL / TOPICAL		6 mg	Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
menthol	MENTHOL	L7T10EIP3A	GEL / TOPICAL	0.1 %w/w		Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
.alpha.-tocopherol acetate	.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	FILM / BUCCAL	0.09 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
diazolidinyl urea	DIAZOLIDINYL UREA	H5RIZ3MPW4	CREAM / TOPICAL		29 mg	Exact identifier — unii+route 21 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	GEL / TOPICAL		4522 mg	Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
trolamine	TROLAMINE	9O3K93S3TK	GEL / TOPICAL		6 mg	Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
.alpha.-tocopherol acetate	.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	TABLET / ORAL	0.5 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
.alpha.-tocopherol acetate	.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	FILM / BUCCAL	0.09 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
.alpha.-tocopherol acetate	.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	CAPSULE / ORAL	2 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
trolamine	TROLAMINE	9O3K93S3TK	GEL / TOPICAL		6 mg	Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
trolamine	TROLAMINE	9O3K93S3TK	GEL / TOPICAL		6 mg	Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
diazolidinyl urea	DIAZOLIDINYL UREA	H5RIZ3MPW4	CREAM / TOPICAL		29 mg	Exact identifier — unii+route 21 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	GEL / TOPICAL		4522 mg	Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	GEL / TOPICAL		4522 mg	Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
diazolidinyl urea	DIAZOLIDINYL UREA	H5RIZ3MPW4	LOTION / TOPICAL	3 %w/w		Exact identifier — unii+route 21 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	GEL / TOPICAL		4522 mg	Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
.alpha.-tocopherol acetate	.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	CAPSULE / ORAL	2 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
.alpha.-tocopherol acetate	.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	FILM / BUCCAL	0.09 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
diazolidinyl urea	DIAZOLIDINYL UREA	H5RIZ3MPW4	OINTMENT / TOPICAL	0.1 %w/w		Exact identifier — unii+route 21 equally ranked IID candidates
menthol	MENTHOL	L7T10EIP3A	GEL / TOPICAL	0.1 %w/w		Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	GEL / TOPICAL		4522 mg	Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
diazolidinyl urea	DIAZOLIDINYL UREA	H5RIZ3MPW4	OINTMENT / TOPICAL	0.1 %w/w		Exact identifier — unii+route 21 equally ranked IID candidates
.alpha.-tocopherol acetate	.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	TABLET / ORAL	0.5 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
diazolidinyl urea	DIAZOLIDINYL UREA	H5RIZ3MPW4	LOTION / TOPICAL	3 %w/w		Exact identifier — unii+route 21 equally ranked IID candidates
diazolidinyl urea	DIAZOLIDINYL UREA	H5RIZ3MPW4	CREAM / TOPICAL		29 mg	Exact identifier — unii+route 21 equally ranked IID candidates
.alpha.-tocopherol acetate	.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	TABLET / ORAL	0.5 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
diazolidinyl urea	DIAZOLIDINYL UREA	H5RIZ3MPW4	LOTION / TOPICAL	3 %w/w		Exact identifier — unii+route 21 equally ranked IID candidates
menthol	MENTHOL	L7T10EIP3A	GEL / TOPICAL	0.1 %w/w		Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
trolamine	TROLAMINE	9O3K93S3TK	GEL / TOPICAL		6 mg	Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
.alpha.-tocopherol acetate	.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	FILM / BUCCAL	0.09 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
diazolidinyl urea	DIAZOLIDINYL UREA	H5RIZ3MPW4	LOTION / TOPICAL	3 %w/w		Exact identifier — unii+route 21 equally ranked IID candidates
.alpha.-tocopherol acetate	.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	CAPSULE / ORAL	2 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	GEL / TOPICAL		4522 mg	Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
diazolidinyl urea	DIAZOLIDINYL UREA	H5RIZ3MPW4	OINTMENT / TOPICAL	0.1 %w/w		Exact identifier — unii+route 21 equally ranked IID candidates
.alpha.-tocopherol acetate	.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	TABLET / ORAL	0.5 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
.alpha.-tocopherol acetate	.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	FILM / BUCCAL	0.09 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
.alpha.-tocopherol acetate	.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	CAPSULE / ORAL	2 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
diazolidinyl urea	DIAZOLIDINYL UREA	H5RIZ3MPW4	CREAM / TOPICAL		29 mg	Exact identifier — unii+route 21 equally ranked IID candidates
menthol	MENTHOL	L7T10EIP3A	GEL / TOPICAL	0.1 %w/w		Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
menthol	MENTHOL	L7T10EIP3A	GEL / TOPICAL	0.1 %w/w		Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
diazolidinyl urea	DIAZOLIDINYL UREA	H5RIZ3MPW4	CREAM / TOPICAL		29 mg	Exact identifier — unii+route 21 equally ranked IID candidates
diazolidinyl urea	DIAZOLIDINYL UREA	H5RIZ3MPW4	OINTMENT / TOPICAL	0.1 %w/w		Exact identifier — unii+route 21 equally ranked IID candidates
.alpha.-tocopherol acetate	.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	CAPSULE / ORAL	2 mg		Exact identifier — unii candidate 21 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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Safetec of America, Inc.	1c5eb3b3-79b3-472a-ae36-ec6a7dc72925	2024-02-07	Warnings	Exact identifier ndc (package): 61010-5000-0 ndc (package): 61010-5000-6 ndc (package): 61010-5000-1 ndc (package): 61010-5000-4 ndc (package): 61010-5000-3 ndc (package): 61010-5000-5 ndc (product): 61010-5000 ndc11 (package): 61010500004 ndc11 (package): 61010500003 ndc11 (package): 61010500006 ndc11 (package): 61010500000 ndc11 (package): 61010500005 ndc11 (package): 61010500001 spl id: 10d33035-4a33-6917-e063-6294a90ac896 spl set id: 1c5eb3b3-79b3-472a-ae36-ec6a7dc72925

Reported adverse events (FAERS/openFDA)#

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

61010-5000, Burn Gel

Label at a glance#

Indications and uses

Dosage and administration

Contacts and useful links#

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Active Ingredient

Purpose

Uses

Warnings

Do not use

OTC - STOP USE SECTION

Keep out of reach of children.

Directions

Inactive ingredients

PRINCIPAL DISPLAY PANEL – 0.125 oz. packet

PRINCIPAL DISPLAY PANEL – 4 oz. bottle

Principal Display Panel - Pouch label

Principal Display Panel - 144 Box label

Principal Display Panel - 25 Box label

Principal Display Panel – 10 Packet Box Label

Related RxNorm Concepts#

DailyMed RxNorm Mappings#

DailyMed Pharmacologic Classes#

DailyMed Product Concepts#

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

DailyMed Dashboard NDC Coverage#

DailyMed Socrata Ingredients#

Products#

NDC Codes#

Ingredients#

Source Document#

Inactive ingredient matches#

openFDA label cross-check#

Reported adverse events (FAERS/openFDA)#