FDA.reportPublic FDA data

Active Ingredient

Manufacturer
Cintas First Aid & Safety | Safetec of America, Inc.
Effective date
2025-08-15
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:59:11

Label at a glance#

ProductLidocaine Hydrochloride
Active ingredientLIDOCAINE HYDROCHLORIDE
Label structure10 sections

Indications and uses

for the temporary pain of relief associated with minor burns

Dosage and administration

adults and children 2 years of age and older: to affected area not more than 3-4 times daily children under 2 years: consult a doctor

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Lidocaine HCl 2.0%

Purpose

OTC - PURPOSE SECTION

Topical pain relief

Uses

INDICATIONS & USAGE SECTION

for the temporary pain of relief associated with minor burns

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

in large quantities, particularly over raw surfaces or blistered areas

  • near eyes, if this happens rinse thoroughly with water

Stop use and ask doctor if

OTC - STOP USE SECTION

  • condition worsens
  • symptoms persist for more than 7 days
  • condition clears up and occurs again within a few days

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

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

Other information

SPL UNCLASSIFIED SECTION

  • store at room temperature

Inactive ingredients

INACTIVE INGREDIENT SECTION

aloe vera, germaben II, propylene glycol, purified water

Questions or Comments?

OTC - QUESTIONS SECTION

1-800-327-2704

Principal Display Panel - Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Burn
Spray

Lidocaine HCl 2%
Water-Soluble

Convenient pump
spray allows no-touch
application. Use as a
first aid treatment for
minor burns, scalds &
sunburn.

2 fl. oz. (59.1 mL)

Xpect®
First aid

Principal Display Panel - Bottle LabelPrincipal Display Panel - Bottle Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1010769lidocaine HCl 2 % Topical SprayPSN4
1010769lidocaine hydrochloride 20 MG/ML Topical SpraySCD4
1010769lidocaine hydrochloride 2 % Topical SpraySY4

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
68421-5100-12021-01-29C16284748780-1ba0f9c33-1743-a910-e053-dadaa90a0b8596f17095-31f3-4b8a-ab22-0caaefaa7476

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68421-5100-1Lidocaine Hydrochloride0.0591 L in 1 BOTTLE, SPRAYSPRAY0.05914

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Lidocaine HydrochlorideACTIVE INGREDIENTV13007Z41A2
LidocaineACTIVE MOIETY98PI2009872
aloe vera leafINACTIVE INGREDIENTZY81Z83H0X2
diazolidinyl ureaINACTIVE INGREDIENTH5RIZ3MPW42
propylene glycolINACTIVE INGREDIENT6DC9Q167V32
waterINACTIVE INGREDIENT059QF0KO0R2

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68421-510068421-5100-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
DIAZOLIDINYL UREAH5RIZ3MPW4IACT
WATER059QF0KO0RIACT
LIDOCAINE HYDROCHLORIDEV13007Z41AACTIR

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 1 · 52 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
propylene glycolPROPYLENE GLYCOL6DC9Q167V3CLOTH / TOPICAL0.03 mg/mgExact identifier — unii+route
46 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3OINTMENT / TOPICAL5148 mgExact identifier — unii+route
46 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3SUSPENSION/ DROPS / TOPICAL0.75 %w/vExact identifier — unii+route
46 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3SPONGE / TOPICAL40 %w/wExact identifier — unii+route
46 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3EMULSION / TOPICAL8 %w/wExact identifier — unii+route
46 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3OINTMENT, AUGMENTED / TOPICAL714 mgExact identifier — unii+route
46 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3SWAB / TOPICAL34.6 %w/wExact identifier — unii+route
46 equally ranked IID candidates
diazolidinyl ureaDIAZOLIDINYL UREAH5RIZ3MPW4OINTMENT / TOPICAL0.1 %w/wExact identifier — unii+route
6 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3CREAM, AUGMENTED / TOPICAL8 %w/wExact identifier — unii+route
46 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3SPRAY / NASAL5 mgExact identifier — unii+dosage form
46 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3SUSPENSION / TOPICAL5.28 %w/vExact identifier — unii+route
46 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3SHAMPOO / TOPICAL8 %w/wExact identifier — unii+route
46 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3SPRAY / NASAL5 mgExact identifier — unii+dosage form
46 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3AEROSOL, FOAM / TOPICAL1800 mgExact identifier — unii+route
46 equally ranked IID candidates
diazolidinyl ureaDIAZOLIDINYL UREAH5RIZ3MPW4CREAM / TOPICAL29 mgExact identifier — unii+route
6 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3SHAMPOO / TOPICAL8 %w/wExact identifier — unii+route
46 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3OINTMENT, AUGMENTED / TOPICAL714 mgExact identifier — unii+route
46 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3CREAM, AUGMENTED / TOPICAL8 %w/wExact identifier — unii+route
46 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3CREAM / TOPICAL76000 mgExact identifier — unii+route
46 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3AEROSOL / TOPICAL19.2 %w/wExact identifier — unii+route
46 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3LOTION / TOPICAL3392 mgExact identifier — unii+route
46 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3SHAMPOO, SUSPENSION / TOPICAL2 %w/wExact identifier — unii+route
46 equally ranked IID candidates
diazolidinyl ureaDIAZOLIDINYL UREAH5RIZ3MPW4LOTION / TOPICAL3 %w/wExact identifier — unii+route
6 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3LOTION, AUGMENTED / TOPICAL2070 mgExact identifier — unii+route
46 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3CREAM / TOPICAL76000 mgExact identifier — unii+route
46 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3GEL, METERED / TOPICAL1225 mgExact identifier — unii+route
46 equally ranked IID candidates
diazolidinyl ureaDIAZOLIDINYL UREAH5RIZ3MPW4LOTION / TOPICAL3 %w/wExact identifier — unii+route
6 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3SOLUTION / TOPICAL4886 mgExact identifier — unii+route
46 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3GEL, METERED / TOPICAL1225 mgExact identifier — unii+route
46 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3SPONGE / TOPICAL40 %w/wExact identifier — unii+route
46 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3SWAB / TOPICAL34.6 %w/wExact identifier — unii+route
46 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3SPRAY / SUBLINGUAL36 mgExact identifier — unii+dosage form
46 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3JELLY / TOPICAL20 %w/wExact identifier — unii+route
46 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3SUSPENSION/ DROPS / TOPICAL0.75 %w/vExact identifier — unii+route
46 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3SYSTEM / TOPICAL4200 mgExact identifier — unii+route
46 equally ranked IID candidates
diazolidinyl ureaDIAZOLIDINYL UREAH5RIZ3MPW4CREAM / TOPICAL29 mgExact identifier — unii+route
6 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3SHAMPOO, SUSPENSION / TOPICAL2 %w/wExact identifier — unii+route
46 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3SPRAY / SUBLINGUAL36 mgExact identifier — unii+dosage form
46 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3CLOTH / TOPICAL0.03 mg/mgExact identifier — unii+route
46 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3AEROSOL / TOPICAL19.2 %w/wExact identifier — unii+route
46 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3AEROSOL, FOAM / TOPICAL1800 mgExact identifier — unii+route
46 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3SOLUTION / TOPICAL4886 mgExact identifier — unii+route
46 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3OINTMENT / TOPICAL5148 mgExact identifier — unii+route
46 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3SYSTEM / TOPICAL4200 mgExact identifier — unii+route
46 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3LOTION, AUGMENTED / TOPICAL2070 mgExact identifier — unii+route
46 equally ranked IID candidates
diazolidinyl ureaDIAZOLIDINYL UREAH5RIZ3MPW4OINTMENT / TOPICAL0.1 %w/wExact identifier — unii+route
6 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3GEL / TOPICAL4522 mgExact identifier — unii+route
46 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3JELLY / TOPICAL20 %w/wExact identifier — unii+route
46 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3SUSPENSION / TOPICAL5.28 %w/vExact identifier — unii+route
46 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3EMULSION / TOPICAL8 %w/wExact identifier — unii+route
46 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3LOTION / TOPICAL3392 mgExact identifier — unii+route
46 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3GEL / TOPICAL4522 mgExact identifier — unii+route
46 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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDECintas First Aid & Safety96f17095-31f3-4b8a-ab22-0caaefaa74762025-08-15WarningsExact identifier
ndc (package): 68421-5100-1
ndc (product): 68421-5100
ndc11 (package): 68421510001
spl id: 3c6ca963-72ba-4e81-e063-6394a90a1fcd
spl set id: 96f17095-31f3-4b8a-ab22-0caaefaa7476

Reported adverse events (FAERS/openFDA)#

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