Burn Gel Pain Relief

Manufacturer: Acme United Corporation | Safetec of America, Inc.
Effective date: 2016-03-07
Label type: HUMAN OTC DRUG LABEL
Version: 3
Source: full-release
Hydrated at: 2026-05-31 23:02:34

Label at a glance#

ProductLidocaine Hydrochloride

Active ingredientLidocaine Hydrochloride

Label structure9 sections

Indications and uses

Temporary pain relief of minor burns. For professional use only.

Dosage and administration

Adults and children 2 years and over: apply to affected area not more than 3 to 4 times daily Children under 2 years: do not use, consult a doctor

Contacts and useful links#

PhoneLabel contact1.800.835.2263

Websitewww.firstaidonly.com

www.FirstAidOnly.com

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Lidocaine HCl 2%

Purpose

OTC - PURPOSE SECTION

Topical pain relief

Uses

INDICATIONS & USAGE SECTION

Temporary pain relief of minor burns. For professional use only.

Warnings

WARNINGS SECTION

For external use only. Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If ingested, get medical help or contact a Poison Control Center directly

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

Stop use and ask doctor if

OTC - STOP USE SECTION

the condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 2 years and over: apply to affected area not more than 3 to 4 times daily

Children under 2 years: do not use, consult a doctor

Other information

SPL UNCLASSIFIED SECTION

store at room temperature (do not freeze)
do not use any opened or torn packs

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Principal Display Panel - Pouch Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FIRST AID ONLY_®

Burn Gel

For Temporary
Pain Relief of
Minor Burns

NET WT 3.5g

Distributed by

Fairfield, CT 06824

1.800.835.2263

www.FirstAidOnly.com

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1011852	lidocaine HCl 2 % Topical Gel	PSN	3
1011852	lidocaine hydrochloride 0.02 MG/MG Topical Gel	SCD	3
1011852	lidocaine hydrochloride 2 % Topical Jelly	SY	3

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
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
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0924-5000-01	2021-01-29	C162847	48780-1	ba0f9c33-5e38-a910-e053-dadaa90a0b85	Burn Gel Pain Relief
0924-5000-02	2021-01-29	C162847	48780-1	ba0f9c33-5e38-a910-e053-dadaa90a0b85	Burn Gel Pain Relief

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0924-5000-00	Lidocaine Hydrochloride	3.5 g in 1 PACKET	GEL	3.5	3
0924-5000-01	Lidocaine Hydrochloride	6 in 1 BOX	GEL	6	3
0924-5000-02	Lidocaine Hydrochloride	25 in 1 BOX	GEL	25	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0924-5000	LIDOCAINE HYDROCHLORIDE GEL [ACME UNITED CORPORATION]	3	Legacy NDC, 3 package rows	20191231_c20f9d77-2572-4050-8b8c-8337ca67124e.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Lidocaine Hydrochloride	ACTIVE INGREDIENT	V13007Z41A	1
Lidocaine	ACTIVE MOIETY	98PI200987	1
.alpha.-tocopherol acetate	INACTIVE INGREDIENT	9E8X80D2L0	1
aloe vera leaf	INACTIVE INGREDIENT	ZY81Z83H0X	1
diazolidinyl urea	INACTIVE INGREDIENT	H5RIZ3MPW4	1
menthol	INACTIVE INGREDIENT	L7T10EIP3A	1
propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	1
trolamine	INACTIVE INGREDIENT	9O3K93S3TK	1
water	INACTIVE INGREDIENT	059QF0KO0R	1

Products#

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

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

Lidocaine Hydrochloride
Lidocaine
Lidocaine Hydrochloride Anhydrous
aloe vera leaf
propylene glycol
diazolidinyl urea
water
menthol
.alpha.-tocopherol acetate
trolamine

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
0924-5000	0924-5000-00, 0924-5000-01, 0924-5000-02

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
Lidocaine Hydrochloride	V13007Z41A	ACTIR
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

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 3 · 133 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
menthol	MENTHOL	L7T10EIP3A	SOLUTION / ORAL		3 mg	Exact identifier — unii candidate 24 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	TABLET, DELAYED RELEASE / ORAL		36 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
diazolidinyl urea	DIAZOLIDINYL UREA	H5RIZ3MPW4	CREAM / TOPICAL		29 mg	Exact identifier — unii candidate 3 equally ranked IID candidates
trolamine	TROLAMINE	9O3K93S3TK	SHAMPOO / TOPICAL	3.7 %w/w		Exact identifier — unii candidate 22 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	LOTION / TOPICAL		3392 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	INJECTION, SOLUTION / INTRAVENOUS		4000 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
trolamine	TROLAMINE	9O3K93S3TK	SOAP / TOPICAL	0.08 %w/w		Exact identifier — unii candidate 22 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	CLOTH / TOPICAL	0.03 mg/mg		Exact identifier — unii candidate 81 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	CREAM, AUGMENTED / TOPICAL	8 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	CAPSULE / ORAL		1072 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	LIQUID / ORAL		29008 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	AEROSOL, METERED / RECTAL	NA		Exact identifier — unii candidate 81 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	LIQUID / RESPIRATORY (INHALATION)	10 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	CREAM / VAGINAL		1225 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	TAMPON / VAGINAL	62.1 mg		Exact identifier — unii candidate 81 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION / DENTAL	2 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION / OPHTHALMIC	1 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION, EXTENDED RELEASE / ORAL		1000 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	SHAMPOO, SUSPENSION / TOPICAL	2 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	AEROSOL / TOPICAL	19.2 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	CAPSULE, DELAYED RELEASE / ORAL	1.7 mg		Exact identifier — unii candidate 81 equally ranked IID candidates
diazolidinyl urea	DIAZOLIDINYL UREA	H5RIZ3MPW4	OINTMENT / TOPICAL	0.1 %w/w		Exact identifier — unii candidate 3 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	INJECTION, SOLUTION / INTRAMUSCULAR		4000 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	LOTION, AUGMENTED / TOPICAL		2070 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	SPRAY, METERED / NASAL		240 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	TABLET / ORAL		64 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION / ORAL		22602 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	AEROSOL, FOAM / VAGINAL	6.4 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	AEROSOL, FOAM / RECTAL		1214 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	ELIXIR / ORAL		9306 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	JELLY / TOPICAL	20 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION, CONCENTRATE / ORAL		2590 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
trolamine	TROLAMINE	9O3K93S3TK	DROPS / NASAL	NA		Exact identifier — unii candidate 22 equally ranked IID candidates
diazolidinyl urea	DIAZOLIDINYL UREA	H5RIZ3MPW4	LOTION / TOPICAL	3 %w/w		Exact identifier — unii candidate 3 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	FILM / BUCCAL	1.48 mg		Exact identifier — unii candidate 81 equally ranked IID candidates
menthol	MENTHOL	L7T10EIP3A	JELLY / NASAL	32.5 mg		Exact identifier — unii candidate 24 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	INJECTION, SOLUTION / SUBCUTANEOUS	1.4 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
menthol	MENTHOL	L7T10EIP3A	SUSPENSION / ORAL		1 mg	Exact identifier — unii candidate 24 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	INJECTION / SUBCUTANEOUS	1.4 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
trolamine	TROLAMINE	9O3K93S3TK	SPONGE / TOPICAL	11 %w/w		Exact identifier — unii candidate 22 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION / TOPICAL	5.28 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	PASTE / DENTAL	0.5 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
trolamine	TROLAMINE	9O3K93S3TK	LIQUID / TOPICAL	NA		Exact identifier — unii candidate 22 equally ranked IID candidates
menthol	MENTHOL	L7T10EIP3A	CAPSULE / ORAL	0.87 mg		Exact identifier — unii candidate 24 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION / AURICULAR (OTIC)	10 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	SPONGE / TOPICAL	40 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	EMULSION / TOPICAL	8 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION/ DROPS / AURICULAR (OTIC)	ADJ PH		Exact identifier — unii candidate 81 equally ranked IID candidates
menthol	MENTHOL	L7T10EIP3A	SOLUTION, CONCENTRATE / ORAL	0.5 mg/1ml		Exact identifier — unii candidate 24 equally ranked IID candidates
trolamine	TROLAMINE	9O3K93S3TK	AEROSOL, FOAM / VAGINAL	2 %w/w		Exact identifier — unii candidate 22 equally ranked IID candidates
trolamine	TROLAMINE	9O3K93S3TK	GEL / TRANSDERMAL		6 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION/ DROPS / OPHTHALMIC	0.75 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	CONCENTRATE / ORAL		7000 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
trolamine	TROLAMINE	9O3K93S3TK	CREAM / VAGINAL		56 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION / RECTAL		90400 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	CAPSULE, EXTENDED RELEASE / ORAL		8 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
trolamine	TROLAMINE	9O3K93S3TK	SPRAY / NASAL	NA		Exact identifier — unii candidate 22 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	GEL / VAGINAL		750 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
menthol	MENTHOL	L7T10EIP3A	DROPS / OPHTHALMIC	NA		Exact identifier — unii candidate 24 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION / AURICULAR (OTIC)	56.55 %w/v		Exact identifier — unii candidate 81 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
1e0d0fcf-9188-4bc3-8791-aa9226a41a0a			c20f9d77-2572-4050-8b8c-8337ca67124e	2016-03-07	Warnings	Exact identifier spl id: 1e0d0fcf-9188-4bc3-8791-aa9226a41a0a spl set id: c20f9d77-2572-4050-8b8c-8337ca67124e

Reported adverse events (FAERS/openFDA)#

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

Burn Gel Pain Relief

Label at a glance#

Indications and uses

Dosage and administration

Contacts and useful links#

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Active ingredients

Purpose

Uses

Warnings

For external use only. Keep out of reach of children.

Do not use

Stop use and ask doctor if

Directions

Other information

Inactive ingredients

Principal Display Panel - Pouch 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)#