FDA.reportPublic FDA data

Pain Relief 4% Lidocaine Dry Patch

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#

ProductPain Relief 4% Lidocaine Dry Patch
Active ingredientLIDOCAINE
Label structure3 sections

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 4%

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

OTC - WHEN USING 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

aluminum silicate, butylated hydroxytoluene, silicon dioxide, mineral oil, rosin, polyisobutylene (1000 mw), styrene/isoprene/styrene block copolymer, titanium dioxide, .alpha.-tocopherol acetate

Package / Principle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Safrel_LIDOCAINE PATCH CARTON_final.jpgSafrel_LIDOCAINE PATCH CARTON_final.jpg

Package / Inner Pouch

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Safrel_LIDOCAINE PATCH POUCH_final.jpgSafrel_LIDOCAINE PATCH POUCH_final.jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1737778lidocaine 4 % Medicated PatchPSN1
1737778lidocaine 0.04 MG/MG Medicated PatchSCD1
1737778lidocaine 4 % 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
71309-911-152024-01-30C16284748780-11030e365-6361-111a-e063-dadaa90a10e2Pain Relief 4% Lidocaine Dry Patch

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71309-911-15Pain Relief 4% Lidocaine Dry Patch1 in 1 POUCHPATCH11
71309-911-15Pain Relief 4% Lidocaine Dry Patch15 in 1 BOXPATCH151

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71309-911PAIN RELIEF 4% LIDOCAINE DRY PATCH (LIDOCAINE) PATCH [SAFREL PHARMACEUTICALS, LLC]1Legacy NDC, 2 package rows20220316_f0ded8a8-1b8d-4276-964e-3a4d389f8bb5.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
71309-91171309-911-15

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
LIDOCAINE98PI200987ACTIB
ALUMINUM SILICATET1FAD4SS2MIACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
MINERAL OILT5L8T28FGPIACT
ROSIN88S87KL877IACT
POLYISOBUTYLENE (1000 MW)5XB3A63Y52IACT
STYRENE/ISOPRENE/STYRENE BLOCK COPOLYMERK7S96QM8DVIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT

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
559fb16a-fec5-4577-a059-26368f8adfc1f0ded8a8-1b8d-4276-964e-3a4d389f8bb52022-03-15WarningsExact identifier
spl id: 559fb16a-fec5-4577-a059-26368f8adfc1
spl set id: f0ded8a8-1b8d-4276-964e-3a4d389f8bb5

Reported adverse events (FAERS/openFDA)#

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