Label: ANTIBACTERIAL GEL FOR MEN- clove,sophora flavescens root,polyaminopropyl biguanide gel

  • NDC Code(s): 84260-011-01
  • Packager: Guangzhou Lvying Biotechnology Co.,Ltd
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated March 11, 2025

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    SOPHORA FLAVESCENS ROOT 10%

    CLOVE 5%

    POLYAMINOPROPYL BIGUANIDE 0.035%

  • PURPOSE

    Antibacterial gel for men

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

  • INDICATIONS & USAGE

    Men's antibacterial gel

  • WARNINGS

    Keep Away fomm fire or Flame for External Use omly

  • DOSAGE & ADMINISTRATION

    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

    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

    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

  • PRINCIPAL DISPLAY PANEL

    observationMedia

  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL GEL FOR MEN 
    clove,sophora flavescens root,polyaminopropyl biguanide gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84260-011
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CLOVE (UNII: K48IKT5321) (CLOVE - UNII:K48IKT5321) CLOVE5 g  in 100 g
    POLYAMINOPROPYL BIGUANIDE (UNII: DT9D8Z79ET) (POLYAMINOPROPYL BIGUANIDE - UNII:DT9D8Z79ET) POLYAMINOPROPYL BIGUANIDE0.035 g  in 100 g
    SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K) (SOPHORA FLAVESCENS ROOT - UNII:IYR6K8KQ5K) SOPHORA FLAVESCENS ROOT10 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    SMILAX GLABRA TUBER (UNII: PES3YXA3LR)  
    PHELLODENDRON CHINENSIS BARK (UNII: 2866QMZ434)  
    ALCOHOL (UNII: 3K9958V90M)  
    CYNOMORIUM COCCINEUM SUBSP. SONGARICUM WHOLE (UNII: 4AF9K48H9O)  
    TRIETHANOLAMINE (UNII: 9O3K93S3TK)  
    POLYGONUM CUSPIDATUM ROOT (UNII: 7TRV45YZF7)  
    CISTANCHE DESERTICOLA WHOLE (UNII: LM25W02G91)  
    EPIMEDIUM BREVICORNU WHOLE (UNII: 56UJF6417L)  
    WATER (UNII: 059QF0KO0R)  
    ASTRAGALUS MONGHOLICUS WHOLE (UNII: IJI7YZ55VS)  
    CARBOMER 980 (UNII: 4Q93RCW27E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84260-011-013 g in 1 TUBE; Type 0: Not a Combination Product03/26/2025
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)03/26/2025
    Labeler - Guangzhou Lvying Biotechnology Co.,Ltd (714445262)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guangzhou Lvying Biotechnology Co., Ltd714445262manufacture(84260-011)