FDA.reportPublic FDA data

Xpect Burn Care

Manufacturer
Cintas Corp | Safetec of America, Inc
Effective date
2025-09-23
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:14:33

Label at a glance#

ProductXpect Burn Care
Active ingredientLIDOCAINE HYDROCHLORIDE
Label structure9 sections

Indications and uses

For the temporary relief of pain 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#

Active Ingredients 

OTC - ACTIVE INGREDIENT SECTION

Lidocaine HCl 2%

Purpose 

OTC - PURPOSE SECTION

Topical Pain Relief 

Uses

INDICATIONS & USAGE SECTION

For the temporary relief of pain associated with minor burns

Warnings 

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

Do not use

  • in large quanitites, particularly over raw surfaces 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
  • 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 a 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 

OTHER SAFETY INFORMATION

  • store at room temperature

Inactive Ingredients 

INACTIVE INGREDIENT SECTION

aloe vera, germaben II, propylene glycol, purified water 

Questions?

OTC - QUESTIONS SECTION

1-877-973-2811 M-F 8am-5pm

Principal Display Panel

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

Manufactured for: Cintas • Mason, OH 45040   www.cintas.com

BottleBottle

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42961-213-01Xpect Burn Care59.1 mL in 1 BOTTLE, SPRAYSPRAY59.14

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
42961-21342961-213-01

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
LIDOCAINE HYDROCHLORIDEV13007Z41AACTIR
ALOE VERA WHOLEKIZ4X2EHYXIACT
DIAZOLIDINYL UREAH5RIZ3MPW4IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT

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
Xpect Burn CareBURN CARECintas Corp3665eb99-9602-4949-8af4-3ce7ed24303c2025-09-23WarningsExact identifier
ndc (package): 42961-213-01
ndc (product): 42961-213
ndc11 (package): 42961021301
spl id: f90c9e19-0bb5-4acc-93be-ed93af636dec
spl set id: 3665eb99-9602-4949-8af4-3ce7ed24303c

Reported adverse events (FAERS/openFDA)#

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