LIDOGUARD

Manufacturer
ViolaCare, Inc.
Effective date
2026-03-25
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:51:28

Label at a glance#

ProductLIDOGUARD
Active ingredientLIDOCAINE
Label structure14 sections

Indications and uses

Temporarily relieves minor pain

Dosage and administration

Adult and children over 12 years: Clean and dry affected area Remove backing from patch by firmly grasping both ends and gently pulling until back separates in the middle Carefully remove smaller portion of backing from the patch and apply exposed portion of patch to affected area Use 1 patch for up to 12 hours Children 12 years or younger: Ask a doctor

Storage and handling

Store at room temperature 20° - 25°C (68°-77°F)

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 4%

Purpose

OTC - PURPOSE SECTION

External Anesthetic

Uses:

INDICATIONS & USAGE SECTION

Temporarily relieves minor pain

Warnings:

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

Do not use

  • More than 1 patch on your body at a time
  • On cut, irritated or swollen skin on puncture wounds
  • For more than one week without consulting a doctor
  • At the same time as other topical analgesics

OTC - WHEN USING SECTION

When using the product

  • Use only as directed
  • Read and follow all directions and warnings on this label
  • Rare cases of serious burns have been reported with products of this type
  • Do not apply to wounds or damaged, broken, or irritated skin
  • Do not allow contact with the eyes and mucous membranes
  • 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 a manner that always keeps the product away from children and pets
  • Used patches still contain the drug product that can produce serious adverse effects if a child or pet chews or ingests this patch
  • A transient burning sensation may occur upon application but generally disappears in several days
  • If a severe burning sensation occurs, discontinue use immediately
  • Discontinue use at least 1 hour before a bath or shower
  • Do not use immediately use after a bath or shower

OTC - STOP USE SECTION

Stop use and ask doctor if

  • Your condition worsens
  • Redness is present
  • Irritation develops
  • Symptoms persist for more than 7 days or a 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

Pregnancy or breast feeding section

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 and pets. 

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

Directions

DOSAGE & ADMINISTRATION SECTION

Adult and children over 12 years:

  • Clean and dry affected area
  • Remove backing from patch by firmly grasping both ends and gently pulling until back separates in the middle
  • Carefully remove smaller portion of backing from the patch and apply exposed portion of patch to affected area
  • Use 1 patch for up to 12 hours


Children 12 years or younger:Ask a doctor

Other information:

STORAGE AND HANDLING SECTION

Store at room temperature 20° - 25°C (68°-77°F)

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Alpha Tocopherol Acetate, Aluminum Glycinate, Aluminum Hydroxide, Aluminum Sulphate, Borax, Collodial Silicon Dioxide, DMDM Hydantoin, Glycerin, Kaolin, Polyacrylic Acid, Polyvinyl Alcohol, Polyvinylpyrrolidone, Propylene Glycol, Purified Water, Sodium Carboxymethyl Cellulose, Sodium Propylene Glycol, Sodium Polyacrylate, Sorbitan Monooleate, Tartric Acid & Titanium Dioxide

Question Section

OTC - QUESTIONS SECTION

​Questions?  Call 877-227-3137

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LidoGuard Image 1LidoGuard Image 1

NDC 85231-100-15

LidoGuard Pain Relief Patch

Pain Relieving Gel Patch

12hr Fast Acting Relief

Maximum Strength

15 Patches - Pain Relieving Gel Patch 

15 Patches 

3.94 in x 5.5 in EACH

Packaged For:

ViolaCare Inc.

Parsippany, New Jersey, 07054

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1737778lidocaine 4 % Medicated PatchPSN3
2717286LidoGuard 4 % Medicated PatchPSN3
2717286lidocaine 0.04 MG/MG Medicated Patch [Lidoguard Pain Relief]SBD3
1737778lidocaine 0.04 MG/MG Medicated PatchSCD3
1737778lidocaine 4 % Medicated PatchSY3
2717286Lidoguard Pain Relief 0.04 MG/MG Medicated PatchSY3

DailyMed Pharmacologic Classes#

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

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130085231100156GTIN-13: 0085231100156
EAN-13: 0085231100156
GTIN-12: 085231100156
UPC-A: 085231100156
GTIN storage (14 digits): 00085231100156
lidocaine-4-generic-label-1.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85231-100-15LIDOGUARD1 in 1 POUCHPATCH13
85231-100-15LIDOGUARD15 in 1 BOXPATCH153

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
85231-100-15EA - Each85231-100f811c00d-2a9b-4627-a235-4b1b022a221712025-07-08

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85231-10085231-100-15

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 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
LIDOGUARDLIDOCAINE 4%ViolaCare, Inc.d8b021b6-cf71-4f7e-9d27-92d0982bd34f2026-03-25WarningsExact identifier
ndc (package): 85231-100-15
ndc (product): 85231-100
ndc11 (package): 85231010015
spl id: 4dd75a34-1b69-c67d-e063-6394a90a1007
spl set id: d8b021b6-cf71-4f7e-9d27-92d0982bd34f

Reported adverse events (FAERS/openFDA)#

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