FDA.reportPublic FDA data

Adellina Numbing Cream

Manufacturer
Guangzhou Haishi Biological Technology Co., Ltd.
Effective date
2025-03-26
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:57:56

Label at a glance#

ProductAdellina Numbing Cream
Active ingredientLIDOCAINE
Label structure11 sections

Indications and uses

For the physical or local anesthesia associated with tattoo

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 5%

Purpose

OTC - PURPOSE SECTION

Local Anesthetic

Uses

INDICATIONS & USAGE SECTION

For the physical or local anesthesia associated with tattoo

For external use only.

WARNINGS SECTION

Avoid contact with the eyes Keep away from heat or flame. Do not use in large quantities, particularly over raw surfaces or blistered areas.

OTC - STOP USE SECTION

Stop use and ask a doctor if redness, irritation, swelling, pain, or other symptoms occurs,or If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.

OTC - DO NOT USE SECTION

Do not use this product if Pregnant or breastfeeding, ask a health professional before use. In case of accidental overdose, get medical help or contact the Poison Control Center immediately. Seal is broken or missing.

OTC - WHEN USING SECTION

Do not exceed the recommended daily dosage unless directed by a doctor. certain persons can develop allergic reactions to ingredients in this product. do not put this product into the rectum by using finger.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of accidental ingestion, seek medical help immediately.

Dosage

DOSAGE & ADMINISTRATION SECTION

Squeeze out an appropriate amount of product and spread evenly on skin.

Inactive ingredients

INACTIVE INGREDIENT SECTION

AQUA 71.3%
PROPYLENE 5%
CARBOMER 0.25%
GLYCERIN 5%
DISODIUM EDTA 0.05%
HYDROXYACETOPHENONE 0.4%
1,2-HEXANEDIOL 5%
MENTHA ARVENSIS LEAF EXTRACT 2%
CHRYSANTHELLUM INDICUM EXTRACT 2%
PORTULACA OLERACEA EXTRACT 2%
PEG-40 HYDROGENATED CASTOR OIL 2%

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label.Label.

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
60771-0011-1Adellina Numbing Cream44 mL in 1 BOTTLECREAM441

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60771-0011ADELLINA NUMBING CREAM (LIDOCAINE) CREAM [GUANGZHOU HAISHI BIOLOGICAL TECHNOLOGY CO., LTD.]1Current NDC, 1 package rows20250328_314a83fe-8bdb-766f-e063-6294a90a61c6.zip

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
60771-001160771-0011-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
1,2-HEXANEDIOLTR046Y3K1GIACT
LIDOCAINE98PI200987ACTIB

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
Adellina Numbing CreamLIDOCAINEGuangzhou Haishi Biological Technology Co., Ltd.314a83fe-8bdb-766f-e063-6294a90a61c62025-03-26WarningsExact identifier
ndc (package): 60771-0011-1
ndc (product): 60771-0011
ndc11 (package): 60771001101
spl id: 314a83fe-8bdc-766f-e063-6294a90a61c6
spl set id: 314a83fe-8bdb-766f-e063-6294a90a61c6

Reported adverse events (FAERS/openFDA)#

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