FDA.reportPublic FDA data

Advanced Seal Barrier plus Pain Relief

Manufacturer
Kericure Inc.
Effective date
2025-01-01
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:50:58

Label at a glance#

ProductAdvanced Seal Barrier plus Pain Relief
Active ingredientLIDOCAINE
Label structure8 sections

Label contents#

Full prescribing information#

Active Ingredients:

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 2%

Purpose:

OTC - PURPOSE SECTION

Topical anesthetic

INDICATIONS & USAGE SECTION

Uses: For the temporary relief of pain and itch in minor cuts, burns, scrapes, skin irritations, insect bites and sunburn

WARNINGS SECTION

Warnings: For external use only. Avoid contact with eyes. Do not ingest. Contact a doctor if pregnant, breastfeeding, or if condition worsens.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

DOSAGE & ADMINISTRATION SECTION

Directions: Adults & children age 2 & older. Shake well then apply spray. DO NOT RUB IN. Allow a clear, thin film to set. Apply up to 3x a day for 7 days. Children under 2 years of age consult a physician

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Purified water, ethanol, polyacrylate polymer, cellulose

SPL UNCLASSIFIED SECTION

Soothe, Seal & ProtectTM

Lidocaine + breathable, elastic barrier

Seals in hydration for Advanced Healing

Cuts • Burns • Rashes • Irritation & More

KeriCureMedical.com

KeriCure Inc. Baltimore, MD 21229

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2373431lidocaine 2 % Topical SprayPSN2
2373431lidocaine 20 MG/ML Topical SpraySCD2
2373431lidocaine 2 % Topical SpraySY2

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
78280-703-01Advanced Seal Barrier plus Pain Relief25 mL in 1 BOTTLE, SPRAYSPRAY252

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78280-703ADVANCED SEAL BARRIER PLUS PAIN RELIEF (LIDOCAINE) SPRAY [KERICURE INC.]2Current NDC, Legacy NDC, 1 package rows20250108_7ac95325-e6e9-4c56-9315-876c00af7c98.zip

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
78280-70378280-703-01

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
LIDOCAINE98PI200987ACTIB
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT
BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW)JZ1374NL9EIACT
HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)S38J6RZN16IACT

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
Advanced Seal Barrier plus Pain ReliefLIDOCAINEKericure Inc.7ac95325-e6e9-4c56-9315-876c00af7c982025-01-01WarningsExact identifier
ndc (package): 78280-703-01
ndc (product): 78280-703
ndc11 (package): 78280070301
spl id: ba0cc9ee-545b-406d-a334-72e029ab397f
spl set id: 7ac95325-e6e9-4c56-9315-876c00af7c98

Reported adverse events (FAERS/openFDA)#

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