Lidozen Patch

Manufacturer
Village Pharma LLC
Effective date
2023-11-29
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 00:03:15

Label at a glance#

ProductLidozen
Active ingredientLIDOCAINE HYDROCHLORIDE, MENTHOL
Label structure7 sections

Indications and uses

For temporary relief of pain

Dosage and administration

Clean and dry affected area. Remove patch from backing and apply to affected area. Use only one patch at a time, and maximum of four patches / day. Leave patch on affected area for up to 8 hours. Do not use patches for longer than five consective days. Children under 12 should consult physician prior to use.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

Lidocaine HCL 4.00%

Menthol 1.00%

OTC - PURPOSE SECTION

Toplcal Anesthetic

External Analgesic

USES:

INDICATIONS & USAGE SECTION

For temporary relief of pain

WARNINGS:

WARNINGS SECTION

  • For external use only.
  • Avoid contact with eyes.
  • If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a physician.

Do not use 

OTC - DO NOT USE SECTION

in large quantities, particularly over raw surfaces or blistered areas.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DIRECTIONS (Adults and Children Over 12 Years):

DOSAGE & ADMINISTRATION SECTION

Clean and dry affected area.

Remove patch from backing and apply to affected area.

Use only one patch at a time, and maximum of four patches / day.

Leave patch on affected area for up to 8 hours.

Do not use patches for longer than five consective days.

Children under 12 should consult physician prior to use.

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Propylene Glycol, Carboxymethyl Cellulose Sodium, Dihydroxyaluminum Aminoacetate, Ethanol, Glycerin, Kaolin, Partially Neutralized Polyacrylate, Polysorbate 80, Polyvinylpyrrolidone 90, Tartaric Acid, Tetrasodium Edetate, Titanium Dioxide, Hydrogenated Castor Oil, Phenoxyethanol, Urea, Water.

SPL UNCLASSIFIED SECTION

Store below 25 degrees Celsius. Avoid directed sunlight.

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

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
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
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
71574-800-052021-10-21C16284748780-1ba0f9c33-32a6-a910-e053-dadaa90a0b85Lidozen Patch
71574-800-052021-01-29C16284748780-1ba0f9c33-32a6-a910-e053-dadaa90a0b85Lidozen Patch

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71574-800-05EA - Each71574-8000b8c6bb8-e72e-4146-88b6-a83b5f64e06b12019-07-02

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71574-80071574-800-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Source Document#

Source XML · Source PDF

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
0b5824f5-903e-560a-e063-6394a90af9f202da73b3-6c57-4ffb-9639-48688879f1562023-11-29WarningsExact identifier
spl id: 0b5824f5-903e-560a-e063-6394a90af9f2
spl set id: 02da73b3-6c57-4ffb-9639-48688879f156

Reported adverse events (FAERS/openFDA)#

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