FDA.reportPublic FDA data

Painless Tattoo Numbing

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#

ProductPainless Tattoo Numbing
Active ingredientLIDOCAINE HYDROCHLORIDE
Label structure8 sections

Indications and uses

For temporary relief of pain and itching.

Dosage and administration

Shake well. Do not spray on face. 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% 

Purpose

OTC - PURPOSE SECTION

External Analgesic

Uses

INDICATIONS & USAGE SECTION

For temporary relief of pain and itching.

Warnings

WARNINGS SECTION

For external use only.

Flammable: Do not use near heat, flame, or while smoking.

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. Keep away from face to avoid breathing it. Avoid contact with eyes. Do not store at temperatures above 120°F. Do not puncture or incinerate.

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

Directions

DOSAGE & ADMINISTRATION SECTION

Shake well. Do not spray on face. 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

Aloe Barbadensis Leaf Extract, Arnica Montana Flower Extract, Aqua (Deionized Water), Dimethyl Sulfone, Disodium EDTA, Ethoxydiglycol, Ethylhexylglycerin, Glycerin, Phenoxyethanol, Propylene Glycol, SD Alcohol 40-B

Product label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

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
QR code linkQR Codeqr-codes.io/1UZ0mj6qzeBimage_019.jpg

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
54723-019-01Painless Tattoo Numbing41 mL in 1 BOTTLELIQUID413

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
54723-01954723-019-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT
ALOE VERA LEAFZY81Z83H0XIACT
DIMETHYL SULFONE9H4PO4Z4FTIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
DIETHYLENE GLYCOL MONOETHYL ETHERA1A1I8X02BIACT
ARNICA MONTANA FLOWEROZ0E5Y15PZIACT
GLYCERINPDC6A3C0OXIACT
PHENOXYETHANOLHIE492ZZ3TIACT
EDETATE DISODIUM7FLD91C86KIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
LIDOCAINE HYDROCHLORIDEV13007Z41AACTIR

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
12024-05-14full-release2026-06-01 00:12:30

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
Painless Tattoo NumbingLIDOCAINE HYDROCHLORIDESambria Pharmaceuticals, LLCefd3289f-dfb2-487c-a76f-00fe8af414e32025-11-12WarningsExact identifier
ndc (package): 54723-019-01
ndc (product): 54723-019
ndc11 (package): 54723001901
spl id: 436c1d6a-b6a4-bed4-e063-6394a90a1dd5
spl set id: efd3289f-dfb2-487c-a76f-00fe8af414e3

Reported adverse events (FAERS/openFDA)#

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