FDA.reportPublic FDA data

Lidocaine Hydrochloride

Manufacturer
Provision Medical | Safetec of America, Inc.
Effective date
2013-11-11
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:50:16

Label at a glance#

ProductLidocaine Hydrochloride
Active ingredientLidocaine Hydrochloride
Label structure7 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#

Active Ingredient

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 g Packet Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

First Aid Burn Cream

The Provision
First Aid
Line™

For Burns
and Cuts

0.9 g (1/32 oz.)

Principal Display Panel – 0.9 g Packet Label
Principal Display Panel – 0.9 g Packet 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
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69103-5000-02024-01-30C16284748780-11030e365-2c0b-111a-e063-dadaa90a10e2Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69103-5000-0Lidocaine Hydrochloride0.9 g in 1 PACKETGEL0.91

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69103-5000LIDOCAINE HYDROCHLORIDE GEL [PROVISION MEDICAL]1Legacy NDC, 1 package rows20220726_a4b62642-197f-4d88-a475-72d5acf35bcd.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
69103-500069103-5000-0

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
cccceda1-ec11-4306-8dc8-fce4e3eb3a98a4b62642-197f-4d88-a475-72d5acf35bcd2013-11-11WarningsExact identifier
spl id: cccceda1-ec11-4306-8dc8-fce4e3eb3a98
spl set id: a4b62642-197f-4d88-a475-72d5acf35bcd

Reported adverse events (FAERS/openFDA)#

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