FDA.reportPublic FDA data

GoodSense Burn Relief Spray 6oz

Manufacturer
Solskyn Personal Care LLC | KIK Piedmont LLC
Effective date
2019-07-16
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:59:52

Label at a glance#

ProductBurn Relief
Active ingredientLIDOCAINE
Label structure12 sections

Dosage and administration

• Shake well • 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: ask a doctor • To apply to face, spray on palm of hand and gently apply

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 0.5%

Purpose

OTC - PURPOSE SECTION

External analgesic

Use

INDICATIONS & USAGE SECTION

INDICATIONS & USAGE SECTION

Temporarily relieves pain and itching due to:

• Sunburn • Minor burns

• Minor cuts • Scrapes

• Insect bites • Minor skin irritations

Dosage & Administration

DOSAGE & ADMINISTRATION SECTION

For the 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 in large quantities, particularly over raw surfaces or

blistered areas.

When using this product:

OTC - WHEN USING SECTION

When using this product:
• Keep out of eyes.
• Use only as directed.
• Do not puncture or incinerate. Contents under pressure. Do
not store at temperature above 120°F.

Stop use and ask a doctor if:

OTC - STOP USE SECTION

Stop use and ask a doctor if:

• Condition gets worse

• Symptoms last more than 7 days

• Symptoms clear up and occur again in a few days

Keep out of reach of children.

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

INSTRUCTIONS FOR USE SECTION

• Shake well

• 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: ask a doctor

• To apply to face, spray on palm of hand and gently apply

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, Glycerin, Propanediol, Aloe Barbadensis Leaf Juice,

Carbomer, Tocopheryl Acetate, PEG-40 Hydrogenated Castor Oil,

Sodium Lauroyl Sarcosinate, Disodium EDTA, Phenoxyethanol,

Sodium Hydroxide

Questions or comments?

OTC - QUESTIONS SECTION

Distributed by:

Geiss, Destin & Dunn, Inc.

Peachtree City, GA 30269

www.valuelabels.com

800-715-3485

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

GoodSense

Burn Relief

Continuous Spray

Topical Analgesic

With LidocainepROVIDES FAST RELIEF FROM:

  • Sunburn
  • Cuts & scrapes
  • Insect bites,
  • Minor burn & sunburn

Compare and Save 100% Satisfaction Guaranteed

NET WT 6 OZ (170 g)

GoodSense Burn Relief Spray_Label_040319.jpgGoodSense Burn Relief Spray_Label_040319.jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1442274lidocaine 0.5 % Topical SprayPSN1
1442274lidocaine 5 MG/ML Topical SpraySCD1
1442274lidocaine 0.5 % Topical SpraySY1

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
70281-640-062023-01-30C16284748780-1f386c64a-0a0e-0266-e053-dadaa90a7c1aGoodSense Burn Relief Spray 6oz

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70281-640-06Burn Relief170 g in 1 CANSPRAY1701

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70281-640BURN RELIEF (LIDOCAINE) SPRAY [SOLSKYN PERSONAL CARE LLC]1Legacy NDC, 1 package rows20190717_8dcf5497-ec60-312c-e053-2a95a90ad54e.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70281-64070281-640-06

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
POLYOXYL 40 HYDROGENATED CASTOR OIL7YC686GQ8FIACT
SODIUM LAUROYL SARCOSINATE632GS99618IACT
CARBOXYPOLYMETHYLENE0A5MM307FCIACT
SODIUM HYDROXIDE55X04QC32IIACT
WATER059QF0KO0RIACT
EDETATE DISODIUM7FLD91C86KIACT
GLYCERINPDC6A3C0OXIACT
PROPANEDIOL5965N8W85TIACT
ALOE VERA LEAFZY81Z83H0XIACT
PHENOXYETHANOLHIE492ZZ3TIACT
LIDOCAINE98PI200987ACTIB

Source Document#

Source XML · Source PDF

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
8dcf58fc-a84a-17f1-e053-2995a90a67a88dcf5497-ec60-312c-e053-2a95a90ad54e2019-07-16WarningsExact identifier
spl id: 8dcf58fc-a84a-17f1-e053-2995a90a67a8
spl set id: 8dcf5497-ec60-312c-e053-2a95a90ad54e

Reported adverse events (FAERS/openFDA)#

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