FDA.reportPublic FDA data

Hot and Cold Lidocaine with Menthol Patch

Manufacturer
Velocity Pharma LLC
Effective date
2019-11-22
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:01:37

Label at a glance#

ProductHot and Cold Lidocaine with Menthol Patch Pain Relief
Active ingredientLIDOCAINE, MENTHOL
Label structure7 sections

Indications and uses

Temporarily relieves minor pain associated with: arthritis, simple backache, bursitis, tendonitis, muscle strains, sprains & bruises.

Dosage and administration

adults: apply patch to affected area for a maximum of 12 hours. Do not use more than 1 patch every 24 hours. children: consult your physician remove protective film, gently apply to affected area.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active IngredientsPurpose
Lidocaine 4 % (240 mg)Topical analgesic
Menthol 1%     (60 mg)Topical analgesic

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves minor pain associated with: arthritis, simple backache, bursitis, tendonitis, muscle strains, sprains & bruises.

Warnings

WARNINGS SECTION

For external use only.

OTC - DO NOT USE SECTION

Do not use if you are allergic or sensitive to lidocaine or menthol. Do not use if pouch is damaged or opened.

When using this product

OTC - WHEN USING SECTION

  • use only as directed
  • avoid contact with eyes or mucous membranes
  • do not apply to open wounds or sensitive skin
  • do not bandage tightly or use a heating pad

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • excessive redness or irritation is present
  • condition worsens
  • pain persists for more than 7 days
  • symptoms clear up and occur again within a few days

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • adults: apply patch to affected area for a maximum of 12 hours. Do not use more than 1 patch every 24 hours.
  • children: consult your physician
  • remove protective film, gently apply to affected area.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Dihydroxyaluminium aminoacetate, disodium EDTA, glycerin, methylparaben, polyvinyl alcohol, propyl
paraben, propylene glycol, purified water, sodium carboxymethyl cellulose, sodium polyacrylate, tartaric
acid, titanium dioxide

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FinalFinal

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1249758lidocaine 4 % / menthol 1 % Medicated PatchPSN2
1249758lidocaine 0.04 MG/MG / menthol 0.01 MG/MG Medicated PatchSCD2
1249758lidocaine 4 % / menthol 1 % Medicated PatchSY2

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
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
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
76168-306-052021-01-29C16284748780-1ba0f9c33-29e6-a910-e053-dadaa90a0b85Hot and Cold Lidocaine with Menthol Patch

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76168-306-05Hot and Cold Lidocaine with Menthol PatchPain Relief5 in 1 BOXPATCH52

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76168-306HOT AND COLD LIDOCAINE WITH MENTHOL PATCH PAIN RELIEF (LIDOCAINE AND MENTHOL) PATCH [VELOCITY PHARMA LLC]2Legacy NDC, 1 package rows20191123_5b41db97-fd9d-4eb6-b935-a1e4e806d2da.zip

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76168-30676168-306-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIHYDROXYALUMINUM AMINOACETATEDO250MG0W6IACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
GLYCERINPDC6A3C0OXIACT
METHYLPARABENA2I8C7HI9TIACT
POLYVINYL ALCOHOL, UNSPECIFIED532B59J990IACT
PROPYLPARABENZ8IX2SC1OHIACT
WATER059QF0KO0RIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMK679OBS311IACT
SODIUM POLYACRYLATE (2500000 MW)05I15JNI2JIACT
TARTARIC ACIDW4888I119HIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
LIDOCAINE98PI200987ACTIB
MENTHOLL7T10EIP3AACTIB

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
97f253b5-fbe6-f148-e053-2995a90aef275b41db97-fd9d-4eb6-b935-a1e4e806d2da2019-11-22WarningsExact identifier
spl id: 97f253b5-fbe6-f148-e053-2995a90aef27
spl set id: 5b41db97-fd9d-4eb6-b935-a1e4e806d2da

Reported adverse events (FAERS/openFDA)#

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