Label: FLOCEAN ANTI-ITCH- benzocaine 5%anti-itch cream

  • NDC Code(s): 84010-017-01
  • Packager: Jiangxi Hemei Pharmaceutical Co., Ltd
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated June 25, 2024

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  • Active Ingredient

    Benzocaine 5%

  • Purpose

    External analgesic

  • Use

    temporarily relieves itching

  • Warnings

    For external use only

  • Do not use

    if you have a vaginal discharge. Consult a physician.

  • When Using

    Avoid contact with eyes

  • Stop Use

    condition worsens, or if symptoms persist formore than 7 days, or clear up and occur again within a few days Do not applyover large areas of the body

  • Ask Doctor

    condition worsens, or if symptoms persist formore than 7 days, or clear up and occur again within a few days Do not applyover large areas of the body

  • Keep Oot Of Reach Of Children

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    adults and children 12 years and older apply a fingertipamount (approximately 1-inch strip) to affected area not more than 3 to 4times daily, Clean nozzle of tube by wiping thoroughly before replacing cap.Keep cap tightly closed between uses.

  • Other information

    children under 12 years consult a doctor

  • Inactive ingredients

    water ,Glycerol ,Propylene Glycol ,Polydimethylsiloxane ,Trolamine,Borneol,MENTHAPIPERITA,Methylparaben ,Chlorhexidine

  • PRINCIPAL DISPLAY PANEL

    1

  • INGREDIENTS AND APPEARANCE
    FLOCEAN ANTI-ITCH 
    benzocaine 5%anti-itch cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84010-017
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    BORNEOL (UNII: M89NIB437X)  
    MENTHA PIPERITA (UNII: 79M2M2UDA9)  
    CHLORHEXIDINE (UNII: R4KO0DY52L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84010-017-0128 g in 1 BOTTLE; Type 0: Not a Combination Product06/25/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01706/25/2024
    Labeler - Jiangxi Hemei Pharmaceutical Co., Ltd (724892056)
    Establishment
    NameAddressID/FEIBusiness Operations
    Jiangxi Hemei Pharmaceutical Co., Ltd724892056label(84010-017) , manufacture(84010-017)
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