CYZONE BODY MANIC (ALUMINUM SESQUICHLOROHYDRATE) LOTION [VENTURA CORPORATION LTD]

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CYZONE BODY MANIC (ALUMINUM SESQUICHLOROHYDRATE) LOTION [VENTURA CORPORATION LTD]
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NDC 13537-122-01
Set ID 547e305f-6d11-4d9e-95ef-e8a96c5bb068
Category HUMAN OTC DRUG LABEL
Packager Ventura Corporation LTD
Generic Name
Product Class
Product Number
Application Number PART350
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Aluminum sesquichlorohydrate 20%

  • Purpose

    Antiperspirant

  • Uses

    • Reduces underarm perspiration
  • Warnings

    For external use only

    Do not use on broken skin

    Ask a doctor before use if you have Kidney desease

    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

    WATER, STEARETH-2, STEARETH-21, PPG-15 STEARYL ETHER, CYCLOMETHICONE, GLYCERIN, BUTYLENE GLYCOL, LARREA DIVARICATA EXTRACT, DICAPRYLYL CARBONATE, TRICLOSAN,BENZALKONIUM CHLORIDE, METHYLPARABEN, BISABOLOL, BHT, LECITHIN, TETRASODIUM EDTA

  • Questions?

    Puerto Rico: 622-3235 (San José)

  • SPL UNCLASSIFIED SECTION

    Puerto Rico: Distribuited by Ventura Corporation Ltd., San Juan, Puerto Rico 00924. Made in Colombia.

  • PRINCIPAL DISPLAY PANEL - 50 ml Container Label

    Body
    manic

    cy°zone

    50 ml e
    (1.6 fl.oz.)

    Principal Display Panel - 50 ml Container Label
  • INGREDIENTS AND APPEARANCE
    CYZONE   BODY MANIC
    aluminum sesquichlorohydrate lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-122
    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)  
    CYCLOMETHICONE (UNII: NMQ347994Z)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
    TRICLOSAN (UNII: 4NM5039Y5X)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-122-0150 mL in 1 BOTTLE, WITH APPLICATOR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35011/14/2011
    Labeler - Ventura Corporation LTD (602751344)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bel Star S.A. (Colombia)880160197MANUFACTURE(13537-122)
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