FDA.reportPublic FDA data

BURN N BITE

Manufacturer
Q.A. Laboratories
Effective date
2022-01-17
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:47:33

Label at a glance#

ProductBURN N BITE
Active ingredientLIDOCAINE, MENTHOL, UNSPECIFIED FORM
Label structure9 sections

Indications and uses

for the temporary relief of pain and discomfort caused by • minor burns • sunburn • scrapes • insect bites • minor skin irritations • rashes due to poison ivy, oak and sumac.

Dosage and administration

Adults and children 2 years of age and older: Apply to the affected area not more than two 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 2%
Menthol 1%

Purpose

OTC - PURPOSE SECTION

Ant-itch, Pain Relief

Uses

INDICATIONS & USAGE SECTION

for the temporary relief of pain and discomfort caused by • minor burns • sunburn • scrapes • insect bites • minor skin irritations • rashes due to poison ivy, oak and sumac.

Warnings

WARNINGS SECTION

For external use only.

When using this product

• Avoid contact with eyes

Do not use

• Under bandages or compresses

Stop use and ask a doctor if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days 

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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: Apply to the affected area not more than two times daily.

Children under 2 years of age: Do not use, consult a doctor

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Deionized water, propylene glycol, aloe, isopropyl alcohol, carbomer, triethanolamine, phenoxyethanol

Questions or comments:

OTC - QUESTIONS SECTION

858-782-6627, 816-421-8081

Stanmar Laboratories     

Division of Q.A. Laboratories

404 Admiral Boulevard Kansas City, MO 64106

Ideazbrands.com

Made in the USA

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BURN N BITEBURN N BITEBURN N BITEBURN N BITE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
199105lidocaine 2 % / menthol 1 % Topical GelPSN2
199105lidocaine 0.02 MG/MG / menthol 0.01 MG/MG Topical GelSCD2
199105lidocaine 2 % / menthol 1 % Topical GelSY2

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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
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
52099-9005-12023-07-28C16284748780-10191ceaa-6e04-198a-e063-dbdaa90aec3eBurn N Bite

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52099-9005-1BURN N BITE141 g in 1 TUBEGEL1412

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52099-9005BURN N BITE (LIDOCAINE, MENTHOL) GEL [Q.A. LABORATORIES]2Legacy NDC, 1 package rows20220126_283be206-8d1b-4508-a0a6-67200d78d46c.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52099-900552099-9005-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
LIDOCAINE98PI200987ACTIB
MENTHOL, UNSPECIFIED FORML7T10EIP3AACTIB
WATER059QF0KO0RIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
ALOEV5VD430YW9IACT
ISOPROPYL ALCOHOLND2M416302IACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
TROLAMINE9O3K93S3TKIACT
PHENOXYETHANOLHIE492ZZ3TIACT

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
4d0bfb71-7503-4386-9fb2-bf39d289a213283be206-8d1b-4508-a0a6-67200d78d46c2022-01-17WarningsExact identifier
spl id: 4d0bfb71-7503-4386-9fb2-bf39d289a213
spl set id: 283be206-8d1b-4508-a0a6-67200d78d46c

Reported adverse events (FAERS/openFDA)#

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