FDA.reportPublic FDA data

Lidocaine Pain Relief Cream

Manufacturer
Shengnan (Guangzhou) Cosmetics Co., LTD
Effective date
2024-01-24
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:07:48

Label at a glance#

ProductLidocaine Pain Relief Cream
Active ingredientLIDOCAINE
Label structure14 sections

Storage and handling

Store in a dry and cool place

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Lidocaine Pain Relief Cream

OTC - ACTIVE INGREDIENT SECTION

LIDOCAINE 4%

OTC - PURPOSE SECTION

Topical Analgesic

INDICATIONS & USAGE SECTION

Temporarily relieves muscle soreness and minor joint pains in the wrist, knees, back, neck, hips, shoulders, elbows.

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

On wounds or damaged skin
With a heating pad or device
With other ointments, creams, sprays, or liniments
If you are allergic to any ingredients of this product

OTC - WHEN USING SECTION

Use only as directed
Avoid contact with the eyes, mucous membranes, or rashes
Do not bandage tightly

OTC - STOP USE SECTION

skin reactions such as redness, swelling, blistering or other discomfort occur
symptoms persist for more than 7 days

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed accidentally , get medical help or contact with Poison Control Center immediately.

DOSAGE & ADMINISTRATION SECTION

Children under 12: Consult a doctor.
Adults and children 12 years and older: For optimum results cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting withl toilet tissue or a clean, soft cloth before application of this product.

STORAGE AND HANDLING SECTION

Store in a dry and cool place

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

INACTIVE INGREDIENT SECTION

Water
Propylene Glycol
Carbomer
Glycerin
Disodium Edta
Hydroxyacetophenone
1.2-Hexanediol
Mentha Arvensis Leaf Extract
Chrysanthellum Indicum Extract
Portulaca Oleracea Extract
Peg-40 Hydrogenated Castor Oil
Epinephrine
Tetracaine
Prilocaine
Borneol

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1421893lidocaine 4 % Topical CreamPSN1
1421893lidocaine 40 MG/ML Topical CreamSCD1
1421893lidocaine 4 % 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
0b4ec9ca-d305-43fc-88dd-7a510313efe0Product name120260105
bb209f42-a85f-4fee-9d3d-c9dded168625Product name120251208
49628fc7-2031-4c28-bd31-0ef3aa8f44a3Product name320251118
a26f29b9-6919-4f09-a354-491df8d2b97dProduct name120251021
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
cbf85893-59ef-423f-87d4-a573c000a8b9Product name820250731
b5b1095b-40cd-8a9e-b111-502545045b07Product name420250325
e190029e-423b-473c-8e04-2ada59b5b711Product name120250314
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
e0031c74-3853-42bc-8e10-86dbbe83992eProduct name220231116
f7046b89-2016-499a-adc6-78479172abc6Product name120230425
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
2686d634-e712-4007-8dbf-3d37c6c4d71fProduct name120181121
122d1fa8-7b9e-49b4-89ce-b062ffd1d947Product name120181030
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
bd49bb86-2d32-4a7a-a594-eeda2e29af42Product name120180118
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
3becbe78-12d9-4ad2-9b4c-1e36f8d1303aProduct name120170815
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
84019-101-01Lidocaine Pain Relief Cream30 g in 1 CANISTERCREAM301
84019-101-01Lidocaine Pain Relief Cream1 in 1 BOXCREAM11
84019-101-02Lidocaine Pain Relief Cream50 g in 1 CANISTERCREAM501
84019-101-02Lidocaine Pain Relief Cream1 in 1 BOXCREAM11
84019-101-03Lidocaine Pain Relief Cream1 in 1 BOXCREAM11
84019-101-03Lidocaine Pain Relief Cream142 g in 1 CANISTERCREAM1421
84019-101-04Lidocaine Pain Relief Cream156 g in 1 CANISTERCREAM1561
84019-101-04Lidocaine Pain Relief Cream1 in 1 BOXCREAM11
84019-101-05Lidocaine Pain Relief Cream1 in 1 BOXCREAM11
84019-101-05Lidocaine Pain Relief Cream170 g in 1 CANISTERCREAM1701
84019-101-06Lidocaine Pain Relief Cream184 g in 1 CANISTERCREAM1841
84019-101-06Lidocaine Pain Relief Cream1 in 1 BOXCREAM11
84019-101-07Lidocaine Pain Relief Cream198 g in 1 CANISTERCREAM1981
84019-101-07Lidocaine Pain Relief Cream1 in 1 BOXCREAM11
84019-101-08Lidocaine Pain Relief Cream1 in 1 BOXCREAM11
84019-101-08Lidocaine Pain Relief Cream213 g in 1 CANISTERCREAM2131
84019-101-09Lidocaine Pain Relief Cream227 g in 1 CANISTERCREAM2271
84019-101-09Lidocaine Pain Relief Cream1 in 1 BOXCREAM11
84019-101-10Lidocaine Pain Relief Cream1 in 1 BOXCREAM11
84019-101-10Lidocaine Pain Relief Cream241 g in 1 CANISTERCREAM2411

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84019-101LIDOCAINE PAIN RELIEF CREAM (4% LIDOCAINE) CREAM [SHENGNAN (GUANGZHOU) COSMETICS CO., LTD]120 package rows20240125_0fae1f38-858e-d448-e063-6294a90a3202.zip

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84019-10184019-101-01, 84019-101-02, 84019-101-03, 84019-101-04, 84019-101-05, 84019-101-06, 84019-101-07, 84019-101-08, 84019-101-09, 84019-101-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
PEG-40 HYDROGENATED LANOLIN959P5CXE48IACT
LIDOCAINE98PI200987ACTIB
WATER059QF0KO0RIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
MAGNESIUM DISODIUM EDTANDT563S5VZIACT
PORTULACA OLERACEA SEEDM08917G08ZIACT
TETRACAINE0619F35CGVIACT
EPINEPHRINEYKH834O4BHIACT
HYDROXYACETOPHENONEG1L3HT4CMHIACT
MENTHA ARVENSIS LEAFA4IWO4DDZ9IACT
CHRYSANTHELLUM INDICUM TOPSTJ856D1Z0IACT
GLYCERINPDC6A3C0OXIACT
1,2-HEXANEDIOLTR046Y3K1GIACT
PRILOCAINE046O35D44RIACT
BORNEOLM89NIB437XIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT

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
0fae1f38-858f-d448-e063-6294a90a32020fae1f38-858e-d448-e063-6294a90a32022024-01-24WarningsExact identifier
spl id: 0fae1f38-858f-d448-e063-6294a90a3202
spl set id: 0fae1f38-858e-d448-e063-6294a90a3202

Reported adverse events (FAERS/openFDA)#

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