FDA.reportPublic FDA data

LidoGuard TM Cream

Manufacturer
ViolaCare, Inc.
Effective date
2025-06-04
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:02:29

Label at a glance#

ProductLidoGuard
Active ingredientLIDOCAINE HYDROCHLORIDE
Label structure12 sections

Indications and uses

Temporarily relieves pain and itching due to: minor cuts sunburn minor scrapes minor burns insect bites minor skin irritations

Dosage and administration

Adults and children 2 years and older: Apply externally to the affected area up to 3-4 times daily. Children under 2 years: Consult a doctor.

Label contents#

Full prescribing information#

Active Ingredient                                           Purpose

OTC - ACTIVE INGREDIENT SECTION

Lidocaine HCl 4%.............................................Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves pain and itching due to:

  • minor cuts
  • sunburn
  • minor scrapes
  • minor burns
  • insect bites
  • minor skin irritations

Warnings

WARNINGS SECTION

For external use only.

When using this product

OTC - WHEN USING SECTION

  • do not use in or near the eyes
  • do not use in large quantities, particularly over raw surfaces or blistered areas

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • Allergic reaction occurs
  • condition worsens or does not improve within 7 days
  • symptoms clear up and return within a few days
  • redness, irritation, swelling, pain or other symptoms begin or increase

OTC - DO NOT USE SECTION

Do not apply over large areas of the body

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 (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Adults and children 2 years and older: Apply externally to the affected area up to 3-4 times daily.
  • Children under 2 years: Consult a doctor.

Other information

SPL UNCLASSIFIED SECTION

  • Store at 20° to 25° C (68° to 77° F); excursions permitted to 15° to 30° C (59° to 86° F)

lnactive lngredients

INACTIVE INGREDIENT SECTION

acrylates/c10-30 alkyl acrylate crosspolymer, aloe barbadensis leaf juice, aminomethyl propanol, butylene glycol, cetearyl alcohol, ceteth-10 phosphate, dicetyl phosphate, dimethicone, disodium EDTA, ethylhexylglycerin, glyceryl stearate, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, phenoxyethanol, steareth-21, water

Questions?

OTC - QUESTIONS SECTION

Call 877-227-3137

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LidoGuard TM Cream - NDC - 85231-200-30 - Pain Relieving Cream - Topical Analgesic - 1.05 oz (30 g)

Carton Label

"Image Description""Image Description"

Manufactured For:

ViolaCare, Inc.

Parsippany, New Jersey, 07054

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1010895lidocaine HCl 4 % Topical CreamPSN1
2716403LidoGuard 4 % Topical CreamPSN1
2716403lidocaine hydrochloride 40 MG/ML Topical Cream [Lidoguard]SBD1
1010895lidocaine hydrochloride 40 MG/ML Topical CreamSCD1
1010895lidocaine hydrochloride 4 % Topical CreamSY1
2716403Lidoguard 4 % Topical CreamSY1
2716403Lidoguard 40 MG/ML Topical CreamSY1

DailyMed Pharmacologic Classes#

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

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
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85231-200-30LidoGuard30 g in 1 TUBECREAM301
85231-200-30LidoGuard1 in 1 CARTONCREAM11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
85231-200-30GM - Gram85231-200b75213c9-6711-47b1-a586-2a17cc34c4c112025-09-12

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85231-20085231-200-30

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S)8Z5ZAL5H3VIACT
ALOE VERA LEAF JUICERUE8E6T4NBIACT
AMINOMETHYLPROPANOLLU49E6626QIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
CETETH-10 PHOSPHATE4E05O5N49GIACT
DIHEXADECYL PHOSPHATE2V6E5WN99NIACT
DIMETHICONE, UNSPECIFIED92RU3N3Y1OIACT
EDETATE DISODIUM7FLD91C86KIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%)86FQE96TZ4IACT
PHENOXYETHANOLHIE492ZZ3TIACT
STEARETH-2153J3F32P58IACT
WATER059QF0KO0RIACT
LIDOCAINE HYDROCHLORIDEV13007Z41AACTIR

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 HCLViolaCare, Inc.531383aa-4f0f-4fe0-91f4-d809b39f160f2025-06-04WarningsExact identifier
ndc (package): 85231-200-30
ndc (product): 85231-200
ndc11 (package): 85231020030
spl id: 36bc3e4d-498b-0170-e063-6394a90a3fa2
spl set id: 531383aa-4f0f-4fe0-91f4-d809b39f160f

Reported adverse events (FAERS/openFDA)#

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