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 pain relief for minor burns

Dosage and administration

for adults and children 2 years of age and older: spray an even layer of burn spray over cleaned affected area not more than 3-4 times daily for children under 2 years of age consult a physician

Label contents#

Full prescribing information#

Active ingredients

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 a doctor if condition worsens or persists for more than 7 days or clears up and returns

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed get medical help or contact Poison Control Center right away

Directions

DOSAGE & ADMINISTRATION SECTION

for adults and children 2 years of age and older: spray an even layer of burn spray over cleaned affected area not more than 3-4 times daily
for children under 2 years of age consult a physician

Inactive ingredients

INACTIVE INGREDIENT SECTION

aloe vera, germaben II, propylene glycol, purified water

Principal Display Panel – 2 fl. oz Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

The Provision
First Aid
Line™

First Aid
Burn Spray

For Temporary
Pain Relief of
Minor Burns

2 fl. oz. (59.1 ml)

Reorder no. 3500

Principal Display Panel – 2 fl. oz Bottle Label

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
69103-5100-0	2024-01-30	C162847	48780-1	1030e365-0c46-111a-e063-dadaa90a10e2	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69103-5100-0	Lidocaine Hydrochloride	0.118 L in 1 BOTTLE	LIQUID	0.118		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69103-5100	LIDOCAINE HYDROCHLORIDE LIQUID [PROVISION MEDICAL]	1	Legacy NDC, 1 package rows	20220726_c2b84d0e-1a6c-4468-bd40-b14f30f28b79.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

Lidocaine Hydrochloride
Lidocaine
Lidocaine Hydrochloride Anhydrous
aloe vera leaf
propylene glycol
propylparaben
methylparaben
diazolidinyl urea
water

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
69103-5100	69103-5100-0

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
Lidocaine Hydrochloride	V13007Z41A	ACTIR
aloe vera leaf	ZY81Z83H0X	IACT
propylene glycol	6DC9Q167V3	IACT
propylparaben	Z8IX2SC1OH	IACT
methylparaben	A2I8C7HI9T	IACT
diazolidinyl urea	H5RIZ3MPW4	IACT
water	059QF0KO0R	IACT

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
804ba9d5-dab0-4491-b744-5a2b207383ed			c2b84d0e-1a6c-4468-bd40-b14f30f28b79	2013-11-11	Warnings	Exact identifier spl id: 804ba9d5-dab0-4491-b744-5a2b207383ed spl set id: c2b84d0e-1a6c-4468-bd40-b14f30f28b79

Reported adverse events (FAERS/openFDA)#

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