FDA.reportPublic FDA data

Antibacterial gel for men

Manufacturer
Guangzhou Lvying Biotechnology Co.,Ltd | Guangzhou Lvying Biotechnology Co., Ltd
Effective date
2025-03-11
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:57:53

Label at a glance#

ProductAntibacterial gel for men
Active ingredientCLOVE, POLYAMINOPROPYL BIGUANIDE, SOPHORA FLAVESCENS ROOT
Label structure9 sections

Storage and handling

Away from direct sunlight and keep in cool place. Keep out of reach of Children. Keep away from fire or flame for external use only.

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

SOPHORA FLAVESCENS ROOT 10%

CLOVE 5%

POLYAMINOPROPYL BIGUANIDE 0.035%

OTC - PURPOSE SECTION

Antibacterial gel for men

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

INDICATIONS & USAGE SECTION

Men's antibacterial gel

WARNINGS SECTION

Keep Away fomm fire or Flame for External Use omly

DOSAGE & ADMINISTRATION SECTION

Before each use, defecate and urinate, and clean around the anus (you can also use sterilised wipes to wipe the perianal area).

Adopt the supine position with knees bent on the left side (consistent with the enema position) and relax the body.

Remove the cap from the front end of the gel tube and insert another booster into the back end of the gel tube. Push the booster gently and apply a small amount of gel to the anal opening as a lubricant to facilitate the insertion of the gel tube.

The last gel tube slowly rotating inserted deep into the anus, if there is flatulence want to exhaust, you can take a deep breath of soil gas way to regulate, until the push booster to push the gel completely into the deep anus.

STORAGE AND HANDLING SECTION

Away from direct sunlight and keep in cool place.
Keep out of reach of Children.
Keep away from fire or flame for external use only.

INACTIVE INGREDIENT SECTION

WATER

SMILAX GLABRA TUBER

CYNOMORIUM COCCINEUM SUBSP.SONGARICUM WHOLE

PHELLODENDRON CHINENSIS BARK

POLYGONUM CUSPIDATUM ROOT

EPIMEDIUM BREVICORNU WHOLE

ASTRAGALUS MONGHOLICUS WHOLE

ALCOHOL

CISTANCHE DESERTICOLA WHOLE

CARBOMER 980

TRIETHANOLAMINE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

observationMediaobservationMedia

DailyMed Pharmacologic Classes#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84260-011-01Antibacterial gel for men3 g in 1 TUBEGEL31

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84260-011ANTIBACTERIAL GEL FOR MEN (CLOVE,SOPHORA FLAVESCENS ROOT,POLYAMINOPROPYL BIGUANIDE) GEL [GUANGZHOU LVYING BIOTECHNOLOGY CO.,LTD]1Current NDC, 1 package rows20250328_300f8e68-db06-c74e-e063-6294a90ad4c7.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84260-01184260-011-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
SMILAX GLABRA TUBERPES3YXA3LRIACT
PHELLODENDRON CHINENSIS BARK2866QMZ434IACT
ALCOHOL3K9958V90MIACT
CLOVEK48IKT5321ACTIB
CYNOMORIUM COCCINEUM SUBSP. SONGARICUM WHOLE4AF9K48H9OIACT
TRIETHANOLAMINE9O3K93S3TKIACT
POLYGONUM CUSPIDATUM ROOT7TRV45YZF7IACT
CISTANCHE DESERTICOLA WHOLELM25W02G91IACT
EPIMEDIUM BREVICORNU WHOLE56UJF6417LIACT
POLYAMINOPROPYL BIGUANIDEDT9D8Z79ETACTIB
WATER059QF0KO0RIACT
SOPHORA FLAVESCENS ROOTIYR6K8KQ5KACTIB
ASTRAGALUS MONGHOLICUS WHOLEIJI7YZ55VSIACT
CARBOMER 9804Q93RCW27EIACT

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
Antibacterial gel for menCLOVE,SOPHORA FLAVESCENS ROOT,POLYAMINOPROPYL BIGUANIDEGuangzhou Lvying Biotechnology Co.,Ltd300f8e68-db06-c74e-e063-6294a90ad4c72025-03-11WarningsExact identifier
ndc (package): 84260-011-01
ndc (product): 84260-011
ndc11 (package): 84260001101
spl id: 300f8e68-db07-c74e-e063-6294a90ad4c7
spl set id: 300f8e68-db06-c74e-e063-6294a90ad4c7

Reported adverse events (FAERS/openFDA)#

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