Hot and Cold Lidocaine with Menthol Patch

Manufacturer
Velocity Pharma LLC | DR SABHARWALS WOUND CARE
Effective date
2017-03-03
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:49:08

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 %Topical analgesic
Menthol 1%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

aluminium hydroxide gel, bentonite, borax, carbomer, carboxymethylcellulose sodium,
colloidal silicon dioxide, dihydroxyaluminumaminoacetate, disodiumedetate, gelatin, glycerin, oleic acid, polysorbate 80, polyvinyl Alcohol, potassium Sorbate, povidone, propylene glycol, sodiummetabisulphite, tartaric acid, trolamine, urea, water

PRINCIPAL DISPLAY PANEL - 3 Topical Patch Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CONTAINS LIDOCAINE with Menthol

PAIN RELIEF PATCH

5TOPICAL PATCHES PER BOX Menthol lido patchMenthol lido patch

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
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76168-099-112020-01-31C16284748780-19d75b9cf-fdbb-f424-e053-dadaa90a57ceHot and Cold Lidocaine with Menthol Patch

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76168-099-11Hot and Cold Lidocaine with Menthol PatchPain Relief5 in 1 CARTONPATCH52
76168-099-11Hot and Cold Lidocaine with Menthol PatchPain Relief1 in 1 POUCHPATCH12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76168-099HOT AND COLD LIDOCAINE WITH MENTHOL PATCH PAIN RELIEF (LIDOCAINE AND MENTHOL) PATCH [VELOCITY PHARMA LLC]2Legacy NDC, 2 package rows20170304_d96693a5-910d-4f85-8bd0-7dd01e5f83d2.zip

Products#

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

DailyMed product names page 1 of 1 · 25 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76168-09976168-099-11

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 23 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
49da2f87-9520-74e8-e054-00144ff8d46cd96693a5-910d-4f85-8bd0-7dd01e5f83d22017-03-03WarningsExact identifier
spl id: 49da2f87-9520-74e8-e054-00144ff8d46c
spl set id: d96693a5-910d-4f85-8bd0-7dd01e5f83d2

Reported adverse events (FAERS/openFDA)#

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