FDA.reportPublic FDA data

Thermacare Heat Therapy Max Strength Lidocaine Pain Relief Rollon

Manufacturer
Clarion Brands LLC
Effective date
2025-11-26
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:19:19

Label at a glance#

ProductThermacare Heat Therapy Max Strength Lidocaine Pain Relief Rollon
Active ingredientLIDOCAINE HYDROCHLORIDE, BENZYL ALCOHOL
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Benzyl alcohol 10%

Lidocaine HCl 4%

OTC - PURPOSE SECTION

Topical anesthetic

INDICATIONS & USAGE SECTION

Use for the temporary relief of pain

WARNINGS SECTION

For external use only

Flammable keep away from heat and open flame

Do not use

  • in large quantities
  • on wounds, damaged, broken, or irritated skin
  • for more than one week without consulting a doctor

When using this product

  • use only as directed. Read and follow all directions and warnings on this label
  • avoid contact with the eyes and mucous membranes
  • do not bandage tightly or apply local heat such as a heating pad or a medicated patch
  • do not use with other topical analgesics

Stop use and ask a doctor if

  • rash or irritation develops
  • symptoms worsen or persist for more than 7 days or clear up and occur again within a few days

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

OTC - WHEN USING SECTION

  • adults and children 2 years of age and older: apply to the affected area no more than 3 to 4 times daily
  • children under 2 years of age: consult a doctor before use

INACTIVE INGREDIENT SECTION

1, 2 hexanediol

alcohol

aloe barbadensis leaf juice

aminomethyl propanol

bisabolol

caprylyl glycol

disodium EDTA

hydroxyethylcellulose

isopropyl alcohol

maltodextrin

polyacrylate crosspolyer-6

propylene glycol

vanillyl butyl ether

water

zingiber officinale (ginger) root extract

OTC - QUESTIONS SECTION

1-800-323-3383

DOSAGE & ADMINISTRATION SECTION

Benzyl alcohol 10%

Lidocaine HCl 4%

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Directions

adults and children 2 years of age and older: apply to affected area no more than 3 to 4 times daily
children under 2 years of age: consult a doctor before use.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Thermacare Heat Therapy

Heat + Max Strength Lidocaine Pain Relief

Roll On NET WT 2.5 OZ (70 g)

No Mess Applicator

Vanishing Scent

Start with Small Amount; Skin Sensitivity Varies

Distributed by: Bridges Consumer Healthcare

811 Broad Street, Suite 600

Chattanooga, TN 37402

2026 Bridges CHC

Thermacare.com

Thermacare Heat Max Lidocaine RollonThermacare Heat Max Lidocaine Rollon

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1943537benzyl alcohol 10 % / lidocaine HCl 4 % Topical SolutionPSN1
1943537benzyl alcohol 0.1 ML/ML / lidocaine hydrochloride 40 MG/ML Topical SolutionSCD1
1943537benzyl alcohol 10 % / lidocaine HCl 4 % Topical SolutionSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
BENZYL ALCOHOL Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
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
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69693-002-25Thermacare Heat Therapy Max Strength Lidocaine Pain Relief Rollon1 mL in 1 BOTTLELIQUID11

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69693-00269693-002-25

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
POLYACRYLATE CROSSPOLYMER-6Q7UI015FF9IACT
VANILLYL BUTYL ETHERS2ULN37C9RIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
CAPRYLYL GLYCOL00YIU5438UIACT
LIDOCAINE HYDROCHLORIDEV13007Z41AACTIR
BENZYL ALCOHOLLKG8494WBHACTIB
1,2-HEXANEDIOLTR046Y3K1GIACT
EDETATE DISODIUM7FLD91C86KIACT
HYDROXYETHYLCELLULOSET4V6TWG28DIACT
WATER059QF0KO0RIACT
BISABOLOL24WE03BX2TIACT
ALOE BARBADENSIS LEAF JUICERUE8E6T4NBIACT
AMINOMETHYLPROPANOLLU49E6626QIACT
GINGERC5529G5JPQIACT
ALCOHOL3K9958V90MIACT
MALTODEXTRIN7CVR7L4A2DIACT

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
Thermacare Heat Therapy Max Strength Lidocaine Pain Relief RollonTHERMACARE HEAT THERAPY MAX STRENGTH LIDOCAINE PAIN RELIEF ROLLONClarion Brands LLC4482d34d-eaca-5522-e063-6394a90a6afb2025-11-26WarningsExact identifier
ndc (package): 69693-002-25
ndc (product): 69693-002
ndc11 (package): 69693000225
spl id: 4482d34d-eacb-5522-e063-6394a90a6afb
spl set id: 4482d34d-eaca-5522-e063-6394a90a6afb

Reported adverse events (FAERS/openFDA)#

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