Lidocaine Dry Patch Plus Menthol

Manufacturer
SAFREL PHARMACEUTICALS, LLC | DR. SABHARWAL'S WOUND CARE
Effective date
2022-03-15
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:48:46

Label at a glance#

ProductLidocaine Dry Patch Plus Menthol
Active ingredientLIDOCAINE, MENTHOL
Label structure3 sections

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 4%

Menthol 1%

Purpose

OTC - PURPOSE SECTION

Topical Anesthetic

Uses

INDICATIONS & USAGE SECTION

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

Warning

WARNINGS SECTION

For external use only

Do not Use

OTC - DO NOT USE SECTION

  • more than 1 patch on your body at a time or on cut, irritated or swollen skin
  • on puncture wounds
  • for more than one week without consulting a doctor
When Using This Product

SPL UNCLASSIFIED SECTION

  • use only as directed. Read and follow all directions and warnings on this label.
  • do not allow contact with the eyes
  • do not bandage tightly or apply local heat (such as heating pads) to the area of use
  • do not use at the same time as other topical analgesics
  • dispose of used patch in manner that always keeps product away from children or pets. Used patches still contain the drug product that can produce serious adverse effects if a child or pet chews or ingests this patch.
Stop Use and Ask a Doctor if

OTC - STOP USE SECTION

  • condition worsens
  • redness is present
  • irritation develops
  • symptoms persist for more than 7 days or clear up and occur again within a few days
  • you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied
If Pregnant or Breast Feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

  • ask a health professional before use.
Keep Out of Reach of Children and Pets

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • If swallowed, get medical help or contact a Poison Control Center right away.
Directions:

DOSAGE & ADMINISTRATION SECTION

Adults and children over 12 years:

  • clean and dry affected area
  • remove backing from patch by firmly grasping both ends and gently pulling until backing separates in middle
  • carefully remove smaller portion of backing from patch and apply exposed portion of patch to affected area
  • once exposed portion of patch is positioned, carefully remove remaining backing to completely apply patch to affected area
  • use 1 patch for up to 12 hours

children 12 years or younger: ask a doctor

Inactive Ingredients

INACTIVE INGREDIENT SECTION

kaolin, polysorbate 80, polyacrylic acid, silicon dioxide, sodium polyacrylate, titanium dioxide

Package / Principle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Outer BoxOuter Box

Package / Inner Pouch

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PouchPouch

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1249758lidocaine 4 % / menthol 1 % Medicated PatchPSN1
1249758lidocaine 0.04 MG/MG / menthol 0.01 MG/MG Medicated PatchSCD1
1249758lidocaine 4 % / menthol 1 % Medicated PatchSY1

DailyMed Pharmacologic Classes#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71309-915-052024-01-30C16284748780-11030e365-4f03-111a-e063-dadaa90a10e2LIDOCAINE DRY PATCH PLUS MENTHOL - lidocaine 4% and menthol 1% patch

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71309-915-05Lidocaine Dry Patch Plus Menthol1 in 1 POUCHPATCH11
71309-915-05Lidocaine Dry Patch Plus Menthol5 in 1 BOXPATCH51

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71309-915LIDOCAINE DRY PATCH PLUS MENTHOL (LIDOCAINE 4% AND MENTHOL 1%) PATCH [SAFREL PHARMACEUTICALS, LLC]1Legacy NDC, 2 package rows20220316_f22c295d-c51c-4b7c-b7f3-c484396e8f09.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71309-91571309-915-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 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
2d43d2a6-7e5d-4922-afd3-0ea5568fa26bf22c295d-c51c-4b7c-b7f3-c484396e8f092022-03-15WarningsExact identifier
spl id: 2d43d2a6-7e5d-4922-afd3-0ea5568fa26b
spl set id: f22c295d-c51c-4b7c-b7f3-c484396e8f09

Reported adverse events (FAERS/openFDA)#

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