FDA.reportPublic FDA data

Arte Maximum strength Numbing Cream

Manufacturer
Sambria Pharmaceuticals, LLC | Southeast Holdings Corp
Effective date
2025-11-12
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:43:43

Label at a glance#

ProductArte Maximum strength Numbing Cream
Active ingredientLIDOCAINE HYDROCHLORIDE
Label structure8 sections

Indications and uses

For temporary relief of pain and itching.

Dosage and administration

Adults and children 12 years of age and over: Clean and dry affected area, apply to affected area not more than 3 to 4 times daily. Children 12 years of age or younger : ask a doctor.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Lidocaine HCL 4.0% w/w

Purpose

OTC - PURPOSE SECTION

External Analgesic

Uses

INDICATIONS & USAGE SECTION

For temporary relief of pain and itching.

Warnings

WARNINGS SECTION

For external use only.

Do not useon wounds or damaged skin, in large quantities, or if you are allergic to any ingredients of this product.

When using this productuse only as directed. Avoid contact with the eyes, rashes, or mucous membranes.

Stop use and ask doctor ifcondition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.

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

Adults and children 12 years of age and over: Clean and dry affected area, apply to affected area not more than 3 to 4 times daily.

Children 12 years of age or younger: ask a doctor.

Other information

SPL UNCLASSIFIED SECTION

Protect this product from excessive heat and direct sun.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aqua (Deionized Water), Arnica Montana Flower Extract, C13-14 Isoparaffin, Chondroitin Sulfate, Emu Oil, Ethoxydiglycol, Ethylhexylglycerin, Glucosamine Sulfate, Isopropyl Palmitate, Laureth-7, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Methylsulfonylmethane (MSM), Phenoxyethanol, Polyacrylamide, Propylene Glycol, Stearic Acid, Triethanolamine

Product label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54723-024-01Arte Maximum strength Numbing Cream30 g in 1 TUBECREAM303

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
54723-02454723-024-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
ARNICA MONTANA FLOWEROZ0E5Y15PZIACT
C13-14 ISOPARAFFINE4F12ROE70IACT
DIMETHYL SULFONE9H4PO4Z4FTIACT
EMU OIL344821WD61IACT
DIETHYLENE GLYCOL MONOETHYL ETHERA1A1I8X02BIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
GLUCOSAMINE SULFATE1FW7WLR731IACT
ISOPROPYL PALMITATE8CRQ2TH63MIACT
LAURETH-7Z95S6G8201IACT
TEA TREE OILVIF565UC2GIACT
PHENOXYETHANOLHIE492ZZ3TIACT
POLYACRYLAMIDE (10000 MW)E2KR9C9V2IIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
CHONDROITIN SULFATE (PORCINE; 5500 MW)56C14G5FWOIACT
STEARIC ACID4ELV7Z65APIACT
TROLAMINE9O3K93S3TKIACT
WATER059QF0KO0RIACT
LIDOCAINE HYDROCHLORIDEV13007Z41AACTIR

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
12025-02-10full-release2026-06-01 00:55:18

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
Arte Maximum strength Numbing CreamLIDOCAINE HYDROCHLORIDESambria Pharmaceuticals, LLCe612a256-3f44-46db-bb6a-e550c2216fdc2025-11-12WarningsExact identifier
ndc (package): 54723-024-01
ndc (product): 54723-024
ndc11 (package): 54723002401
spl id: 436c23a5-7aac-c334-e063-6394a90ad47e
spl set id: e612a256-3f44-46db-bb6a-e550c2216fdc

Reported adverse events (FAERS/openFDA)#

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