FDA.reportPublic FDA data

LidoPatch

Manufacturer
3T Federal Solutions LLC | Katecho
Effective date
2012-03-12
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:31:11

Label at a glance#

ProductLidoPatch Pain Relief
Active ingredientlidocaine, menthol
Label structure9 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 3.99%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

Glycerol, Water, Acrylamide/acrylate co-polymer, (Poly) vinyl pyrrolidone, Germaben II

Questions?

OTC - QUESTIONS SECTION

Email info@lidopatch.com

SPL UNCLASSIFIED SECTION

MFG by JAR Laboratories, Elmhurst, IL 60126

PRINCIPAL DISPLAY PANEL - 3 Topical Patch Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 50682 527 03

GET PAIN
RELIEF NOW!

LidoPatch®

CONTAINS LIDOCAINE
PAIN
RELIEF
PATCH

  • SAME ACTIVE INGREDIENT AS
    LEADING PRESCRIPTION PATCH
  • ONE PATCH FOR 24 HOUR PAIN RELIEF
  • FOR RELIEF OF LOCALIZED PAIN
  • FAST ACTING
  • ULTRA THIN, FLEXIBLE, TRIM TO FIT

3 TOPICAL PATCHES PER BOX

Principal Display Panel - 3 Topical Patch Carton
Principal Display Panel - 3 Topical Patch Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1249758lidocaine 4 % / menthol 1 % Medicated PatchPSN1
1249763LidoPatch 4 % / 1 % Medicated PatchPSN1
1249763lidocaine 0.04 MG/MG / menthol 0.01 MG/MG Medicated Patch [Lidopatch]SBD1
1249758lidocaine 0.04 MG/MG / menthol 0.01 MG/MG Medicated PatchSCD1
1249758lidocaine 4 % / menthol 1 % Medicated PatchSY1
1249763LidoPatch (lidocaine 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
50682-527-032019-11-13C16284748780-197449f38-b909-f6ea-e053-dbdaa90aa703LidoPatch™
50682-527-072019-11-13C16284748780-197449f38-b909-f6ea-e053-dbdaa90aa703LidoPatch™
50682-527-302019-11-13C16284748780-197449f38-b909-f6ea-e053-dbdaa90aa703LidoPatch™

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50682-527-03LidoPatchPain Relief1 in 1 POUCHPATCH11
50682-527-03LidoPatchPain Relief3 in 1 CARTONPATCH31
50682-527-07LidoPatchPain Relief7 in 1 CARTONPATCH71
50682-527-07LidoPatchPain Relief1 in 1 POUCHPATCH11
50682-527-30LidoPatchPain Relief30 in 1 CARTONPATCH301
50682-527-30LidoPatchPain Relief1 in 1 POUCHPATCH11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50682-527LIDOPATCH PAIN RELIEF (LIDOCAINE AND MENTHOL) PATCH [3T FEDERAL SOLUTIONS LLC]1Legacy NDC, 6 package rows20120316_de85ffbf-c92d-4a5a-8b12-e6525f039ab3.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
lidocaineACTIVE INGREDIENT98PI2009871
mentholACTIVE INGREDIENTL7T10EIP3A1
lidocaineACTIVE MOIETY98PI2009871
mentholACTIVE MOIETYL7T10EIP3A1
AcrylamideINACTIVE INGREDIENT20R035KLCI1
Diazolidinyl UreaINACTIVE INGREDIENTH5RIZ3MPW41
GlycerinINACTIVE INGREDIENTPDC6A3C0OX1
UreaINACTIVE INGREDIENT8W8T17847W1

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50682-52750682-527-03, 50682-527-07, 50682-527-30

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
lidocaine98PI200987ACTIB
mentholL7T10EIP3AACTIB
GlycerinPDC6A3C0OXIACT
Acrylamide20R035KLCIIACT
Diazolidinyl UreaH5RIZ3MPW4IACT
Urea8W8T17847WIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 2 · 85 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
GlycerinGLYCERINPDC6A3C0OXCAPSULE, LIQUID FILLED / ORAL185 mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSOLUTION / NASAL25 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXEMULSION / INTRAVENOUS2.2 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
UreaUREA8W8T17847WTABLET, EXTENDED RELEASE / ORAL0.01 mgExact identifier — unii candidate
7 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXDROPS / NASAL10 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXGEL / TRANSDERMAL500 mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXGEL / TOPICAL500 mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXLIQUID / TOPICAL2.5 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
UreaUREA8W8T17847WINSERT / VAGINAL50 mgExact identifier — unii candidate
7 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXCAPSULE, COATED / ORAL14.21 mgExact identifier — unii candidate
75 equally ranked IID candidates
UreaUREA8W8T17847WDOUCHE / VAGINAL8 %w/wExact identifier — unii candidate
7 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXCLOTH / TOPICAL0.05 mg/mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXTABLET / ORAL42 mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXOINTMENT / TOPICALNAExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXAEROSOL / TOPICAL3 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXFILM, EXTENDED RELEASE / TRANSDERMAL306.2 mgExact identifier — unii candidate
75 equally ranked IID candidates
UreaUREA8W8T17847WSYSTEM / TOPICAL840 mgExact identifier — unii candidate
7 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXAEROSOL, FOAM / TOPICAL21 mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXJELLY / VAGINALNAExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXCREAM / VAGINAL60 mgExact identifier — unii candidate
75 equally ranked IID candidates
UreaUREA8W8T17847WCREAM / VAGINAL0.64 %w/wExact identifier — unii candidate
7 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSUSPENSION/ DROPS / ORAL750 mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSOLUTION / AURICULAR (OTIC)63.64 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXINJECTION, SUSPENSION / SUBCUTANEOUS1.6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSOLUTION / DENTAL15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSOLUTION/ DROPS / AURICULAR (OTIC)25 mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS225 mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXTABLET / PERIODONTAL0.53 mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXMOUTHWASH / BUCCAL100 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXINJECTION, SOLUTION / INTRAMUSCULAR15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
UreaUREA8W8T17847WTABLET, EFFERVESCENT / ORAL60 mgExact identifier — unii candidate
7 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSPRAY, METERED / NASAL13 mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXDOUCHE / VAGINAL1 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSUPPOSITORY / RECTAL440 mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXINJECTION / INTRADERMAL1.6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXDROPS / ORAL300 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXINJECTION, EMULSION / INTRAVENOUS24100 mgExact identifier — unii candidate
75 equally ranked IID candidates
Diazolidinyl UreaDIAZOLIDINYL UREAH5RIZ3MPW4OINTMENT / TOPICAL0.1 %w/wExact identifier — unii candidate
3 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXCREAM / TOPICAL1720 mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSUPPOSITORY / VAGINAL227.9 mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXELIXIR / ORAL5621 mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXPASTE, DENTIFRICE / DENTAL18 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSYSTEM / IONTOPHORESIS168.1 mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSOLUTION / TOPICAL1971 mgExact identifier — unii candidate
75 equally ranked IID candidates
UreaUREA8W8T17847WTABLET, COATED / ORAL0.02 mgExact identifier — unii candidate
7 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXCONCENTRATE / ORAL1800 mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXINJECTION, SOLUTION / INTRAVENOUS15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
Diazolidinyl UreaDIAZOLIDINYL UREAH5RIZ3MPW4LOTION / TOPICAL3 %w/wExact identifier — unii candidate
3 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXPASTE / DENTAL20 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXTABLET, CHEWABLE / ORAL12 mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXLIQUID / ORAL2400 mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSYSTEM / TOPICAL18144 mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSOLUTION / RESPIRATORY (INHALATION)5 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXINJECTION / SUBCUTANEOUS450 mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXCAPSULE, EXTENDED RELEASE / ORAL265 mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXINJECTION / INTRAVENOUS33750 mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSUSPENSION / AURICULAR (OTIC)0.05 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSPONGE / TOPICAL2 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXLOTION / TOPICAL3990 mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSOAP / TOPICAL0.76 %w/wExact identifier — unii candidate
75 equally ranked IID candidates

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
dec971e0-6bec-4ae4-aec4-76c8ded82c47de85ffbf-c92d-4a5a-8b12-e6525f039ab32012-03-12WarningsExact identifier
spl id: dec971e0-6bec-4ae4-aec4-76c8ded82c47
spl set id: de85ffbf-c92d-4a5a-8b12-e6525f039ab3

Reported adverse events (FAERS/openFDA)#

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