Ophyte Tattoo Numbing Cream

Manufacturer
Changsha Beiliang E-commerce Co., Ltd
Effective date
2023-12-23
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:05:35

Label at a glance#

ProductOphyte Tattoo Numbing Cream
Active ingredientLIDOCAINE
Label structure13 sections

Dosage and administration

Adults: When practical, cleanse theaffected area with mild soap andwarm water, and rinse thoroughlyGently dry by patting or blotting withtoilet tissue or a soft cloth beforeapplication of this product.

Storage and handling

Keep away from direct sunlight orheat. Store at room temperaturebetween 15°C and 30°C(59°F-86°F). This package is child-resistant.Keep out of reach of children. In case of accidental overdose oringestion, call a doctor or poisoncontrol center immediately. Do not use this product if the sealis broken or missing.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 5%

Purpose

OTC - PURPOSE SECTION

Local Anesthetic

Use

INDICATIONS & USAGE SECTION

For temporary relief of local and anorectal itching, discomfort, and inflammation associated with anorectal disorders.
For temporary relief of pain, burning, and soreness.

Warnings

WARNINGS SECTION

lf symptoms worsen or do notimprove within 7 days, seek medicaadvice.
Do not exceed the recommendeodaily dosage without doctor's
instruction.
Consult a doctor immediately if bleeding occurs.
Do not insert this product into the rectum using fingers or any applicator.
Some people may be allergic to the ingredients.Discontinue use and consult a doctor if symptoms persist or worsen,including redness,
irritation, swelling, or pain.
Note: Discontinue use and consult a
doctor if symptoms persist or
worsen, including redness, irritation.
swelling, or pain due to possible
allergies to product ingredients

Do not use

OTC - DO NOT USE SECTION

Some people may be allergic tothe ingredients. Discontinue use andconsult a doctor if symptoms persistor worsen,including rednessirritation,swelling,or pain.

When Using

OTC - WHEN USING SECTION

If symptoms worsen or do not improve within 7 days, seek medicaladvice.Do not exceed the recommended daily dosage without doctor'sinstruction.Consult a doctor immediately if bleeding occurs.
Do not insert this product into the rectum using fingers or any applicator.
Some people may be allergic to the ingredients. Discontinue use and consult a doctor if symptoms persistor worsen,including redness,irritation,swelling,or pain.

Stop Use

OTC - STOP USE SECTION

Discontinue use and consult adoctor if symptoms persist orworsen, including redness, irritation,swelling, or pain due to possibleallergies to product ingredients.

Ask Doctor

OTC - ASK DOCTOR SECTION

Discontinue use and consult a doctor if symptoms persist or worsen, including redness, irritation. swelling, or pain due to possible
allergies to product ingredients

Keep Oot Of Reach Of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

This package is child-resistant.Keep out of reach of children

Directions

DOSAGE & ADMINISTRATION SECTION

Adults: When practical, cleanse theaffected area with mild soap andwarm water, and rinse thoroughlyGently dry by patting or blotting withtoilet tissue or a soft cloth beforeapplication of this product.

Other information

STORAGE AND HANDLING SECTION

Keep away from direct sunlight orheat.
Store at room temperaturebetween 15°C and 30°C(59°F-86°F).
This package is child-resistant.Keep out of reach of children. In case of accidental overdose oringestion, call a doctor or poisoncontrol center immediately. Do not use this product if the sealis broken or missing.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Vitamin E Allantoin, Mineral Oil.Dimethicone,MethylparabenPropylparaben, Petrolatum, IPBCDiazolidinyl Urea, Glycerin,Cetostearyl Alcohol, IsopropylMyristate, Propylene Glycol,Ammonium,Methacrylate, PurifiedWater, Laurocapram, Steareth-2.Steareth-21 Rose Oil

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

001001002002003003004004

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
83887-002-012025-01-30C16284748780-12cef2736-a391-d83d-e063-dadaa90ab31f83887-002
83887-002-022025-01-30C16284748780-12cef2736-a391-d83d-e063-dadaa90ab31f83887-002
83887-002-032025-01-30C16284748780-12cef2736-a391-d83d-e063-dadaa90ab31f83887-002
83887-002-042025-01-30C16284748780-12cef2736-a391-d83d-e063-dadaa90ab31f83887-002

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83887-002-01Ophyte Tattoo Numbing Cream30 g in 1 TUBECREAM301
83887-002-02Ophyte Tattoo Numbing Cream50 g in 1 BOTTLECREAM501
83887-002-03Ophyte Tattoo Numbing Cream60 g in 1 BOTTLECREAM601
83887-002-04Ophyte Tattoo Numbing Cream100 g in 1 BOTTLECREAM1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83887-002OPHYTE TATTOO NUMBING CREAM (NUMBING CREAM) CREAM [CHANGSHA BEILIANG E-COMMERCE CO., LTD]14 package rows20231224_0d281d68-021e-675d-e063-6294a90a07dd.zip

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83887-00283887-002-01, 83887-002-02, 83887-002-03, 83887-002-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

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
0d281d68-021f-675d-e063-6294a90a07dd0d281d68-021e-675d-e063-6294a90a07dd2023-12-23WarningsExact identifier
spl id: 0d281d68-021f-675d-e063-6294a90a07dd
spl set id: 0d281d68-021e-675d-e063-6294a90a07dd

Reported adverse events (FAERS/openFDA)#

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