TIDL PAIN RELIEF HEAT THERAPY ROLL-ON

Manufacturer
Shenzhen Sam Technology Co., Ltd.
Effective date
2024-07-12
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:15:15

Label at a glance#

ProductTIDL PAIN RELIEF HEAT THERAPY ROLL-ON
Active ingredientMENTHOL, LIDOCAINE
Label structure12 sections

Dosage and administration

·Adults and children 12 years of age and older:Apply to affected area not more than 3 to 4 times daily ·Children under 12 years of age:Consult physician

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 4%
Menthol 1%

Purpose

OTC - PURPOSE SECTION

Topical Anesthetic
Topical Analgesic

Use

INDICATIONS & USAGE SECTION

For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, and sprains

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

do not use wiih heating pad or device

When Using

OTC - WHEN USING SECTION

·avoid contact with the eyes or mucous membranes
·do not apply to wounds or damaged skin
·do not apply to irritated skin
·do not bandage
·wash hands after use with cool water
·do not use with heating pad or device
·spray product away from nose,eyes,and mouth
·do not use in large quantities, particularly over raw surfaces or blistered areas

Stop Use

OTC - STOP USE SECTION

if condition worsens, or if symptoms persist for more than 7 days, or clear up and reoccur again within a few days

Ask Doctor

OTC - ASK DOCTOR SECTION

if condition worsens, or if symptoms persist for more than 7 days, or clear up and reoccur again within a few days

Keep Oot Of Reach Of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If accidentally ingested, get medical help or contact a Poison Control Center immediately. Make sure to turn child safety spray lock to off position when not in use. If pregnant or breast-feeding, ask a healthcare professional before use.

Directions

DOSAGE & ADMINISTRATION SECTION

·Adults and children 12 years of age and older:Apply to affected area not more than 3 to 4 times daily
·Children under 12 years of age:Consult physician

Inactive ingredients

INACTIVE INGREDIENT SECTION

Borneol, Carbohydrates, Ginger Extract, Mugwort Leaf Extract, Saffron Extract, Vanillyl butyl, Water

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1804176lidocaine 4 % / menthol 1 % Topical GelPSN1
1804176lidocaine 0.04 MG/MG / menthol 0.01 MG/MG Topical GelSCD1
1804176lidocaine 4 % / menthol 1 % Topical GelSY1

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
84214-002-01TIDL PAIN RELIEF HEAT THERAPY ROLL-ON85 g in 1 BOTTLEGEL851

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84214-002TIDL PAIN RELIEF HEAT THERAPY ROLL-ON (PAIN RELIEF HEAT THERAPY ROLL-ON) GEL [SHENZHEN SAM TECHNOLOGY CO., LTD.]1Current NDC, 1 package rows20240716_1d0b7b8f-9e5d-00f7-e063-6394a90af87c.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84214-00284214-002-01

Ingredients#

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

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

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
TIDL PAIN RELIEF HEAT THERAPY ROLL-ONPAIN RELIEF HEAT THERAPY ROLL-ONShenzhen Sam Technology Co., Ltd.1d0b7b8f-9e5d-00f7-e063-6394a90af87c2024-07-12WarningsExact identifier
ndc (package): 84214-002-01
ndc (product): 84214-002
ndc11 (package): 84214000201
spl id: 1d0b7b8f-9e5e-00f7-e063-6394a90af87c
spl set id: 1d0b7b8f-9e5d-00f7-e063-6394a90af87c

Reported adverse events (FAERS/openFDA)#

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