Label: CYZONE BLUE AND BLUE FOR HIM- 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 May 27, 2011

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Aluminum sesquichlorohydrate 17%

  • Purpose

    Antiperspirant

  • Use

    • Reduces underarm perspiration
  • Warnings

    For external use only

    Do not use on broken skin

    Ask a doctor before use if you have kidney disease

    Stop use and ask a doctor if rash or irritation occurs

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Apply to underarms only
  • Inactive Ingredients

    Aqua (water), steareth-2,ppg-15 stearyl ether, steareth-21, parfum (fragrance), dicaprylyl carbonate, cyclopentasiloxane, triclosan, cyclohexasiloxane, tetrasodium edta, benzalkonium chloride, bisabolol, magnesium nitrate, methylchloroisothiazolinone, magnesium chloride, methylisothiazolinone.

  • Questions?

    P.R.: 622-3235 (San José).

  • PRINCIPAL DISPLAY PANEL - 50 ML Bottle Label

    ®
    cy°zone

    BLUE & BLUE ♂

    FOR HIM
    50 ML e (1.6 FL.OZ.)

    DESODORANTE ANTITRANSPIRANTE ROLL ON

    Principal Display Panel - 50 ML Bottle Label
  • INGREDIENTS AND APPEARANCE
    CYZONE  BLUE AND BLUE FOR HIM
    aluminum sesquichlorohydrate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-360
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Aluminum Sesquichlorohydrate (UNII: UCN889409V) (Aluminum Sesquichlorohydrate - UNII:UCN889409V) Aluminum Sesquichlorohydrate0.17 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    STEARETH-2 (UNII: V56DFE46J5)  
    STEARETH-21 (UNII: 53J3F32P58)  
    DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    TRICLOSAN (UNII: 4NM5039Y5X)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    MAGNESIUM NITRATE (UNII: 77CBG3UN78)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-360-0150 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35005/27/2011
    Labeler - Ventura Corporation (San Juan, P.R) (602751344)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bel Star S.A. (Colombia)880160197MANUFACTURE