FDA.reportPublic FDA data

LIDOCAINE

Manufacturer
Sichuan Gumo Brand Management Co.,Ltd
Effective date
2023-04-21
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:54:46

Label at a glance#

ProductLIDOCAINE
Active ingredientLIDOCAINE
Label structure11 sections

Indications and uses

for temporary relief of local and anorectal discomfort associated with anorectal disorder or inflammation

Dosage and administration

Adults : When practical , cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blottingwith toilet tissue or a soft cloth , before application of this product. Apply up to 6 times a day, Children up under 12 years of age: consult a doctor.

Storage and handling

keep away from direct sunlight or heata. store in room temperature ( 59-86 F/15-30 C )

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 5%

Purpose

OTC - PURPOSE SECTION

Local Anesthetic

Uses

INDICATIONS & USAGE SECTION

for temporary relief of local and anorectal discomfort associated with anorectal disorder or inflammation

Warnings

WARNINGS SECTION

Warnings ( For extemal use only )

When using this product

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 or any medical device or applicator.

Stop use

OTC - STOP USE SECTION

n/a

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

Incase of accidental ingestion , seek medical attention immediately

Directions

DOSAGE & ADMINISTRATION SECTION

Adults : When practical , cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blottingwith toilet tissue or a soft cloth , before application of this product.

Apply up to 6 times a day,

Children up under 12 years of age: consult a doctor.

Other Information

STORAGE AND HANDLING SECTION

keep away from direct sunlight or heata.

store in room temperature ( 59-86 F/15-30 C )

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Allantoin, Aloe Barbadensis Leaf Juice, Benzyl Alcohol, Carbomer, Cholesterol, Dimenthyl Isosorbide, Disodium EDTA , Hydrogenated Polydece, Lecithin, Neopentyl Glycol Dicaprylate/Dicaprate, Acetate, Trideceth-6, Triethanolamine

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

83365-003-0183365-003-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1366789lidocaine 5 % Rectal CreamPSN1
1366789lidocaine 50 MG/ML Rectal CreamSCD1
1366789lidocaine 5 % Rectal CreamSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
LIDOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
83365-003-012024-07-30C16284748780-11030e365-67b3-111a-e063-dadaa90a10e283365-003
83365-003-012024-01-30C16284748780-11030e365-67b3-111a-e063-dadaa90a10e283365-003

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83365-003-01LIDOCAINE56 g in 1 BOXCREAM561

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83365-003LIDOCAINE CREAM [SICHUAN GUMO BRAND MANAGEMENT CO.,LTD]11 package rows20230422_f9d4e0f6-59a4-ce0f-e053-6294a90a6be5.zip

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83365-00383365-003-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SODIUM POLYACRYLATE (2500000 MW)05I15JNI2JIACT
ALLANTOIN344S277G0ZIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
HYDROGENATED POLYDECENE TYPE IU333RI6EB7IACT
LECITHIN, SOYBEAN1DI56QDM62IACT
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATEVLW429K27KIACT
TROLAMINE9O3K93S3TKIACT
ALPHA-TOCOPHEROLH4N855PNZ1IACT
TRIDECETH-63T5PCR2H0CIACT
ALOE VERA LEAFZY81Z83H0XIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
DIMETHYL ISOSORBIDESA6A6V432SIACT
BENZYL ALCOHOLLKG8494WBHIACT
CHOLESTEROL97C5T2UQ7JIACT
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
f9d4e0f6-59a5-ce0f-e053-6294a90a6be5f9d4e0f6-59a4-ce0f-e053-6294a90a6be52023-04-21WarningsExact identifier
spl id: f9d4e0f6-59a5-ce0f-e053-6294a90a6be5
spl set id: f9d4e0f6-59a4-ce0f-e053-6294a90a6be5

Reported adverse events (FAERS/openFDA)#

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