FDA.reportPublic FDA data

GoodSense Burn Relief Gel

Manufacturer
Solskyn Personal Care LLC | KIK Piedmont LLC
Effective date
2019-06-28
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:59:48

Label at a glance#

ProductGoodSense Burn Relief Gel
Active ingredientLIDOCAINE HYDROCHLORIDE
Label structure12 sections

Indications and uses

tempory relief of pain and itching associated with sunburn, minor burns, minor cuts, scrapes, minor skin irritations, and insect bites. For temporary relief of itching associated with minor skin irritations and rashes due to eczema, insect bites, and poison oak.

Dosage and administration

adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily. children under 2 years of age: do not use, ask a doctor.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 0.5%

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

  • tempory relief of pain and itching associated with sunburn, minor burns, minor cuts, scrapes, minor skin irritations, and insect bites.

Dosage & Administration

DOSAGE & ADMINISTRATION SECTION

For temporary relief of itching associated with minor skin irritations and rashes due to eczema, insect bites, and poison oak.

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

Do not use this in large quantities, particularly over raw surfaces or blistered areas.

When using this product

OTC - WHEN USING SECTION

When using this product avoid contact with the eyes.

Stop use and ask a doctor

OTC - STOP USE SECTION

if condition worsens or if symptoms persist for more than 7 days or symptoms 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

INSTRUCTIONS FOR USE SECTION

  • adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily.
  • children under 2 years of age: do not use, ask a doctor.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf Juice, Blue 5, Carbomer. Disodium, EDTA Glycerin, Menthol, Phenoxyethanol, Polysorbate 20, Propanediol, SD Alcohol (1.85% w/w). Sodium Hydroxide, Water, Yellow 5

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

GOODSENSE

BURN RELIEF

GEL

with

Lidocaine HCl

  • Soothes & Relieves
  • Restores Moisture
  • Topical Analgesic Gel

with ALOE

Compare to active ingredients of

Solarcaine

100% satisfaction guaranteed

NET WT 8 OZ (226 g)

PKLA-41212-GSF1

GoodSense Burn Relief Gel Front Label.jpgGoodSense Burn Relief Gel Front Label.jpg

GoodSense Burn Relief Gel Back Label.jpgGoodSense Burn Relief Gel Back Label.jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1011849lidocaine HCl 0.5 % Topical GelPSN2
1011849lidocaine hydrochloride 0.005 MG/MG Topical GelSCD2
1011849lidocaine hydrochloride 0.5 % 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
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
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
70281-618-262023-01-30C16284748780-1f386c64a-39af-0266-e053-dadaa90a7c1aGoodSense Burn Relief Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70281-618-26GoodSense Burn Relief Gel226 g in 1 BOTTLEGEL2262

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70281-618GOODSENSE BURN RELIEF GEL (LIDOCAINE HCL) GEL [SOLSKYN PERSONAL CARE LLC]2Legacy NDC, 1 package rows20190629_7e9d7986-f372-f3d2-e053-2a91aa0a93a2.zip

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70281-61870281-618-26

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
LIDOCAINE HYDROCHLORIDEV13007Z41AACTIR
ALCOHOL3K9958V90MIACT
WATER059QF0KO0RIACT
ALOE VERA LEAFZY81Z83H0XIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
EDETATE DISODIUM7FLD91C86KIACT
GLYCERINPDC6A3C0OXIACT
MENTHOLL7T10EIP3AIACT
PHENOXYETHANOLHIE492ZZ3TIACT
POLYSORBATE 207T1F30V5YHIACT
PROPANEDIOL5965N8W85TIACT
SODIUM HYDROXIDE55X04QC32IIACT
BASIC YELLOW 507BP340B4TIACT

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
8c567735-aabb-6e33-e053-2a95a90abc7a7e9d7986-f372-f3d2-e053-2a91aa0a93a22019-06-28WarningsExact identifier
spl id: 8c567735-aabb-6e33-e053-2a95a90abc7a
spl set id: 7e9d7986-f372-f3d2-e053-2a91aa0a93a2

Reported adverse events (FAERS/openFDA)#

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