FDA.reportPublic FDA data

SAMNYTE Tattoo Numbing Cream

Manufacturer
Sainite Trading Shenzhen Co., Ltd.
Effective date
2024-01-23
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:07:48

Label at a glance#

ProductSAMNYTE Tattoo Numbing Cream
Active ingredientLIDOCAINE
Label structure10 sections

Indications and uses

For temporary relief of local discomfort, itching, pain, soreness, or burning in the perianal area associated with anorectal disorders.

Dosage and administration

Adults and Children 12 years and older: When practical, cleanse the affected area with mild soap and warm water and rinse thotoughly. Gently dry by patting or blotting with toilet tissue or a soft cloth, before application of this product. Apply externally to the affected area uo to 6 times daily.

Storage and handling

● Keep away from direct sunlight or heat ● Store in room temperature (59-86°F/15-30°C)

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 5%

Purpose

OTC - PURPOSE SECTION

Topical Anesthetic

Uses

INDICATIONS & USAGE SECTION

For temporary relief of local discomfort, itching, pain, soreness, or burning in the perianal area associated with anorectal disorders.

Warnings

WARNINGS SECTION

For external use only

Do not this product

OTC - DO NOT USE SECTION

Pregnant or breastfeeding, ask a health professional before use.

When using this product

OTC - WHEN USING SECTION

Do not exceed the recommended daily dosage unless directed by a doctor
Do not put into the rectum by using fingers or any mechanical device or applicator.

Stop use and ask a doctor if

OTC - STOP USE SECTION

Condition worsens, or does not imprcve within 7 days. Certain persons can develop allergic reactions to ingredients in this product. If the symptom being treateddoes not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase. Discontinue use

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of accidental ingestion, seek madical attention immediately

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and Children 12 years and older: When practical, cleanse the affected area with mild soap and warm water and rinse thotoughly.
Gently dry by patting or blotting with toilet tissue or a soft cloth, before application of this product. Apply externally to the affected area uo to 6 times daily.

Other Informatiom

STORAGE AND HANDLING SECTION

● Keep away from direct sunlight or heat
● Store in room temperature (59-86°F/15-30°C)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aloe barbadebsis leaf juice (Aloe vera), Water, Lecithin (Soybean), Propylene Glycol, Tocopheryl Acetate, Carbomer, Menthol, Triethanolamine

30ml / 1.06 Fl.Oz

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

82929-010-0182929-010-01

40ml / 1.41 Fl.Oz

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

82929-010-0282929-010-02

60ml / 2.12 Fl.Oz

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

82929-010-0382929-010-03

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1534792lidocaine 5 % Topical CreamPSN1
1534792lidocaine 50 MG/ML Topical CreamSCD1
1534792lidocaine 5 % 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
82929-010-01SAMNYTE Tattoo Numbing Cream30 mL in 1 BOTTLE, PLASTICEMULSION301
82929-010-02SAMNYTE Tattoo Numbing Cream40 mL in 1 BOTTLE, PLASTICEMULSION401
82929-010-03SAMNYTE Tattoo Numbing Cream60 mL in 1 BOTTLE, PLASTICEMULSION601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82929-010SAMNYTE TATTOO NUMBING CREAM (LIDOCAINE) EMULSION [SAINITE TRADING SHENZHEN CO., LTD.]13 package rows20240125_0faaaa82-a06b-f9ca-e063-6294a90a150c.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82929-01082929-010-01, 82929-010-02, 82929-010-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
TROLAMINE9O3K93S3TKIACT
ALOE VERA WHOLEKIZ4X2EHYXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
MENTHOLL7T10EIP3AIACT
LIDOCAINE98PI200987ACTIB
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
LECITHIN, SOYBEAN1DI56QDM62IACT

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
0faaaa82-a06c-f9ca-e063-6294a90a150c0faaaa82-a06b-f9ca-e063-6294a90a150c2024-01-23WarningsExact identifier
spl id: 0faaaa82-a06c-f9ca-e063-6294a90a150c
spl set id: 0faaaa82-a06b-f9ca-e063-6294a90a150c

Reported adverse events (FAERS/openFDA)#

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