FDA.reportPublic FDA data

Tough Seal Hot Spot plus Pain Relief

Manufacturer
Kericure Inc.
Effective date
2020-06-01
Label type
OTC ANIMAL DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:40:45

Label at a glance#

ProductTough Seal Hot Spot plus Pain Relief
Active ingredientLIDOCAINE
Label structure8 sections

Label contents#

Full prescribing information#

Active Ingredients:

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 1%

Purpose:

OTC - PURPOSE SECTION

Topical anasthetic

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. For use on dogs, cats, horses and other small animals.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep away from children 2 years of age and younger.

DOSAGE & ADMINISTRATION SECTION

Directions: Shake well then apply firm spray.

DO NOT RUB IN. Allow a thin, clear film to set. Barrier is invisible once dry and safe if licked. Apply up to 3x a day for 7 days. Consult a veterinarian if condition worsens.

INACTIVE INGREDIENT SECTION

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

SPL UNCLASSIFIED SECTION

HOT SPOT PAIN RELIEF HYDROGEL

Relieve & protect hot spots, rashes, skin irritations & more!

340 SPRAYS

Made in the USA

TOUGH SEAL®

Soothe, Seal & Protect®

Questions? info@Kericure.com

Kericure Inc. Baltimore, MD 21229

KeriCure®.com

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1549223lidocaine 1 % Topical SprayPSN1
1549223lidocaine 10 MG/ML Topical SpraySCD1
1549223lidocaine 1 % Topical SpraySY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
LIDOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78280-702-20Tough Seal Hot Spot plus Pain Relief55 mL in 1 BOTTLE, SPRAYSPRAY551

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78280-702TOUGH SEAL HOT SPOT PLUS PAIN RELIEF (LIDOCAINE) SPRAY [KERICURE INC.]11 package rows20200610_a48591dc-f217-42df-949e-e755313749bf.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
78280-70278280-702-20

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 24 · 475 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Flarestop Hemorrhoid LidocaineLIDOCAINEChelsea Pharmacceuticals LLCb8a589f7-7131-4807-9bcb-84af3078e2582026-09-10WarningsName fallback
generic name: LIDOCAINE
Pain Relieving Lidocaine PatchLIDOCAINEYYBA CORPaf8c84fd-224c-72b3-e053-2a95a90a95682026-09-07WarningsName fallback
generic name: LIDOCAINE
Lidocaine CreamLIDOCAINEInvaDerm Corporation5a7273d1-1dbc-420e-e063-6294a90a86292026-09-01WarningsName fallback
generic name: LIDOCAINE
LIDOCAINELIDOCAINEREMEDYREPACK INC.dfef4554-aeb4-4bdf-9557-648d3e84af3c2026-08-31Warnings, Adverse reactionsName fallback
generic name: LIDOCAINE
AnievaLCLIDOCAINEBlackstone Products, LLCddaba14c-10de-44e2-ae13-9217e20cb48e2026-08-29WarningsName fallback
generic name: LIDOCAINE
LidocaineLIDOCAINEA-S Medication Solutions3fbe48b5-128a-471c-8ecb-45e903b567402026-08-28Warnings, Adverse reactionsName fallback
generic name: LIDOCAINE
LAIYINHE Numbing Cream Anorectal (Hemorrhoidal) CreamLIDOCAINEGuangzhou Hechuang Commercial Service Co.,Ltd.59f0fa16-5eb0-e6bb-e063-6294a90aacf52026-08-26WarningsName fallback
generic name: LIDOCAINE
CVS Pain ReliefLIDOCAINECVS Pharmacy4ecbc263-e0d4-18d5-e063-6294a90a72e92026-08-26WarningsName fallback
generic name: LIDOCAINE
CVS Pain Relief Lidocaine XLLIDOCAINECVS Pharmacy4aa286e3-e274-8095-e063-6394a90ae8712026-08-26WarningsName fallback
generic name: LIDOCAINE
LidocaineLIDOCAINESt. Mary's Medical Park Pharmacy9dc3059c-3a3d-5810-e053-2a95a90ab0ba2026-08-26Warnings, Adverse reactionsName fallback
generic name: LIDOCAINE
Lidocaine Pain ReliefLIDOCAINECardinal Health, 110 dba LEADER025d508b-ec4f-466c-b3e8-ba9b18d07b462026-08-26WarningsName fallback
generic name: LIDOCAINE
Foot Pain Relief PadsLIDOCAINEShanghai Chuangshi Medical Technology (Group) Co., Ltd.5a18ff72-8a3e-5cdb-e063-6394a90a61622026-08-25WarningsName fallback
generic name: LIDOCAINE
LidocaineLIDOCAINEAmneal Pharmaceuticals LLC960f6d0a-82af-45e9-89d5-cea808004ebb2026-08-25Warnings, Adverse reactionsName fallback
generic name: LIDOCAINE
Big Toe Joint Pain Relief PatchLIDOCAINEGuangzhou Liuquanmiao Import & Export Trade Co., Ltd.59c8ff98-55c7-796d-e063-6394a90af73a2026-08-24WarningsName fallback
generic name: LIDOCAINE
Lidocaine Numbing CreamLIDOCAINEShanghai Chuangshi Medical Technology (Group) Co., Ltd.599b425a-0e96-76df-e063-6394a90a48ff2026-08-21WarningsName fallback
generic name: LIDOCAINE
Rugby PAIN RELIEF PATCHESLIDOCAINERUGBY LABORATORIESb34e40c8-a257-46cf-9399-f55df9b4102d2026-08-20WarningsName fallback
generic name: LIDOCAINE
Dr. Scholls Blister Pain Relief Complete KitLIDOCAINEScholl's Wellness Company LLC58c2b35c-e1ed-7ea8-e063-6294a90a14942026-08-19WarningsName fallback
generic name: LIDOCAINE
Dr. Scholls Blister Pain Relief Complete KitLIDOCAINEScholl's Wellness Company LLC585e740b-e4fa-d2aa-e063-6294a90a09822026-08-19WarningsName fallback
generic name: LIDOCAINE
Gembooxt Topical Numbing CreamLIDOCAINEGuangdong Quadrant Ecological Technology Co., Ltd.49951a3e-3b62-3d66-e063-6294a90a93602026-08-12WarningsName fallback
generic name: LIDOCAINE
Numbing CreamLIDOCAINE100 KARMA INC35b5ba9d-da1d-55d6-e063-6294a90a5fa82026-08-12WarningsName fallback
generic name: LIDOCAINE

Reported adverse events (FAERS/openFDA)#

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