FDA.reportPublic FDA data

Lidocaine Hydrochloride

Manufacturer
Dealmed Medical Supplies LLC | Safetec of America, Inc.
Effective date
2022-03-08
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:48:47

Label at a glance#

ProductLidocaine Hydrochloride
Active ingredientLidocaine Hydrochloride
Label structure10 sections

Indications and uses

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

Dosage and administration

for adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily children under 2 years of age: do not use, consult a doctor

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Lidocaine HCI (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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

If ingested, get medical help or contact a Poison Control Center right away.

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 a doctor if

OTC - STOP USE SECTION

  • 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

  • for adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily
  • children under 2 years of age: do not use, consult a doctor

Other information

OTHER SAFETY INFORMATION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions or Comments?

OTC - QUESTIONS SECTION

1-800-456-7077

Principal Display Panel - 0.9g Box Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70082-500-01

dealmed

Burn
Gel

For temporary relief
of minor burns

144
PACKETS

NET WT. 0.9g
PER PACKET

Principal Display Panel - 0.9g Box Label
Principal Display Panel - 0.9g Box Label

Principal Display Panel - 0.9g Pouch Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

dealmed

Burn Gel

0.9g (1/32 oz.)

Dealmed • Brooklyn, NY

www.dealmed.com

Principal Display Panel - 0.9g Pouch Label
Principal Display Panel - 0.9g Pouch Label

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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70082-500-012024-01-30C16284748780-11030e365-01e0-111a-e063-dadaa90a10e2Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70082-500-01Lidocaine Hydrochloride0.9 g in 1 POUCHGEL0.91
70082-500-01Lidocaine Hydrochloride144 in 1 BOXGEL1441

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70082-500LIDOCAINE HYDROCHLORIDE GEL [DEALMED MEDICAL SUPPLIES LLC]1Legacy NDC, 2 package rows20220318_9f02911b-b0be-454a-8889-8307592b6aed.zip

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70082-50070082-500-01

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
Lidocaine HydrochlorideV13007Z41AACTIR
aloe vera leafZY81Z83H0XIACT
propylene glycol6DC9Q167V3IACT
diazolidinyl ureaH5RIZ3MPW4IACT
water059QF0KO0RIACT
mentholL7T10EIP3AIACT
.alpha.-tocopherol acetate9E8X80D2L0IACT
trolamine9O3K93S3TKIACT

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
dfd6261a-3c16-426e-b595-aea1573fb2909f02911b-b0be-454a-8889-8307592b6aed2022-03-08WarningsExact identifier
spl id: dfd6261a-3c16-426e-b595-aea1573fb290
spl set id: 9f02911b-b0be-454a-8889-8307592b6aed

Reported adverse events (FAERS/openFDA)#

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