Label: CYZONE XPRESS YOUR BODY SENSITIVE- aluminum sesquichlorohydrate liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated July 10, 2012

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  • SPL UNCLASSIFIED SECTION

    Información del medicamento

  • Ingredientes activos

    Aluminum sesquichlorohydrate 20%

  • Propósito

    Antitranspirante

  • Uso

    • Reduce la transpiración de las axilas
  • Advertencias

    • Sólo para uso externo.

    • No usar en piel dañada o lastimada

    • Consulte con el doctor en caso de sufrir de enfermedad renal

    • Detenga su uso y consulte al doctor si sucede enrojecimiento

    • Mantener fuera del alcance de los niños. Si es ingerido obtener ayuda médica o contactar al centro de Control de Envenenamiento inmediatamente
  • Instrucciones

    • Aplicar solamente en las axilas.
  • Ingredientes inactivos

    Aqua (water), steareth-2, steareth-21, ppg-15 stearyl ether, cyclopentasiloxane, cyclohexasiloxane, parfum (fragrance), dicaprylyl carbonate, bisabolol, triclosan, methylparaben, aloe barbadensis leaf juice, propylene glycol, benzalkonium chloride, bht, tetrasodium edta, chamomilla recutita flower extract (chamomilla recutita (matricaria) flower extract).

  • SPL UNCLASSIFIED SECTION

    PR: Distributed by Ventura Corporation, Ltd. San Juan, Puerto Rico 00926.

  • PRINCIPAL DISPLAY PANEL - 50 ml Bottle Label

    xpress
    your body

    Sensitive

    desodorante
    antitranspirante
    piel sensible

    50 ml e (1.6 fl.oz)

    cy°zone

    PRINCIPAL DISPLAY PANEL - 50 ml Bottle Label
  • INGREDIENTS AND APPEARANCE
    CYZONE   XPRESS YOUR BODY SENSITIVE
    aluminum sesquichlorohydrate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-431
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Aluminum Sesquichlorohydrate (UNII: UCN889409V) (Aluminum Sesquichlorohydrate - UNII:UCN889409V) Aluminum Sesquichlorohydrate0.2 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    steareth-2 (UNII: V56DFE46J5)  
    steareth-21 (UNII: 53J3F32P58)  
    ppg-15 stearyl ether (UNII: 1II18XLS1L)  
    cyclomethicone 5 (UNII: 0THT5PCI0R)  
    cyclomethicone 6 (UNII: XHK3U310BA)  
    dicaprylyl carbonate (UNII: 609A3V1SUA)  
    levomenol (UNII: 24WE03BX2T)  
    triclosan (UNII: 4NM5039Y5X)  
    methylparaben (UNII: A2I8C7HI9T)  
    aloe vera leaf (UNII: ZY81Z83H0X)  
    propylene glycol (UNII: 6DC9Q167V3)  
    benzalkonium chloride (UNII: F5UM2KM3W7)  
    butylated hydroxytoluene (UNII: 1P9D0Z171K)  
    edetate sodium (UNII: MP1J8420LU)  
    chamomile (UNII: FGL3685T2X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-431-0150 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35006/08/2012
    Labeler - Ventura Corporation LTD. (602751344)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bel Star S.A. (Colombia)880160197MANUFACTURE(13537-431)
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