FDA.reportPublic FDA data

Tattoo numbing cream

Manufacturer
BLOOMWELL GARDENS LLC
Effective date
2025-02-26
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:56:09

Label at a glance#

ProductTattoo numbing cream
Active ingredientLIDOCAINE
Label structure9 sections

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 4% - Local anesthetic for 8 hours

PURPOSE

OTC - PURPOSE SECTION

External Analgesic

DOSAGE & ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

  • Due to the different in temprature and skin type, the duration of the numbness effect will be different.
  • First test in a small area is recommended to ensure the best numbness effect.

USEAGE BEFORE TATTOOING

INDICATIONS & USAGE SECTION

1. Clean hands and treatment are with mild soap and warm water. Rinse thoroughly and gently pat dry.

2. Apply a thick numbing cream to the treatment area, making sure to cover the tattoo and its surroundings.

3. Wrap tightly with plastic wrap and wait for 40-60 munutes.

4. Wipe away any exceess residue and allow addtional 15-25 minutes for the numbing effect to reach its peak. Then you can begin the tattoo procedure.

DO NOT USE

OTC - DO NOT USE SECTION

  • If you are pregnant or nursing, consult with your healthcare provider before use.
  • The product seal is broken or missing.
  • Do not use on broken or irritated skin.
  • People who are allergic to the ingredients in this product.

ATTENTION

WARNINGS SECTION

  • Do not get into eyes.
  • Do not swallow.
  • Do not exceed the recommended dosage unless directed by a doctor.
  • Do not insert this product into the recturm.

IMPORTANT

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

OTHER INGREDIENTS

INACTIVE INGREDIENT SECTION

Water, Glycerin, Butyllene Glycol, Butter Oil, Squalane, Dimethicone, Menthol, Borneol, Xanthan Gum.

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

85284-001-0185284-001-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1421893lidocaine 4 % Topical CreamPSN2
1421893lidocaine 40 MG/ML Topical CreamSCD2
1421893lidocaine 4 % Topical CreamSY2

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
a26f29b9-6919-4f09-a354-491df8d2b97dProduct name120251021
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
122d1fa8-7b9e-49b4-89ce-b062ffd1d947Product name120181030
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
a993dfc5-f219-4460-bde6-30dd724d9ef0Product name120160818
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
85284-001-01Tattoo numbing cream50 g in 1 CONTAINERCREAM502

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
85284-001TATTOO NUMBING CREAM (LIDOCAINE) CREAM [BLOOMWELL GARDENS LLC]2Current NDC, 1 package rows20250228_2ea9d34e-408d-f8d6-e063-6394a90a72a4.zip

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85284-00185284-001-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Name, UNII, Kind table
NameUNIIKind
SQUALANEGW89575KF9IACT
RICE GERM7N2B70SFEZIACT
PRILOCAINE046O35D44RIACT
SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL724GKU717MIACT
MENTHOLL7T10EIP3AIACT
ALOE BARBADENSIS LEAFZY81Z83H0XIACT
PROCAINE4Z8Y51M438IACT
GLYCERYL STEARATE230OU9XXE4IACT
XANTHAN GUMTTV12P4NEEIACT
DIMETHICONE92RU3N3Y1OIACT
LIDOCAINE98PI200987ACTIB
GLYCERINPDC6A3C0OXIACT
SHEANUT OILO88E196QRFIACT
CETEARYL GLUCOSIDE09FUA47KNAIACT
MENTHA ARVENSIS LEAFA4IWO4DDZ9IACT
BUTYLENE GLYCOL3XUS85K0RAIACT
CENTELLA ASIATICA ROOT8MXU1P42J0IACT
SODIUM HYALURONATEYSE9PPT4THIACT
TOCOPHEROLR0ZB2556P8IACT
TETRACAINE0619F35CGVIACT
CETEARYL ALCOHOL2DMT128M1SIACT
BORNEOLM89NIB437XIACT

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
Tattoo numbing creamLIDOCAINEBLOOMWELL GARDENS LLC2ea9d34e-408d-f8d6-e063-6394a90a72a42025-02-26WarningsExact identifier
ndc (package): 85284-001-01
ndc (product): 85284-001
ndc11 (package): 85284000101
spl id: 2f17a8d3-01fd-955d-e063-6394a90a08a3
spl set id: 2ea9d34e-408d-f8d6-e063-6394a90a72a4

Reported adverse events (FAERS/openFDA)#

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