CYZONE NITRO DESODORANTE ANTITRANSPIRANTE ROLL-ON FM (ALUMINUM SESQUICHLOROHYDRATE) EMULSION [VENTURA CORPORATION LTD]

CYZONE NITRO DESODORANTE ANTITRANSPIRANTE ROLL-ON FM (ALUMINUM SESQUICHLOROHYDRATE) EMULSION [VENTURA CORPORATION LTD]
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NDC 13537-963-01
Set ID de764e5b-d117-44ac-9d84-233ac2d01526
Category HUMAN OTC DRUG LABEL
Packager Ventura Corporation LTD
Generic Name
Product Class
Product Number
Application Number PART350
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Aluminum sesquichlorohydrate 13.6 %

  • 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, PPG-15 STEARYL ETHER, STEARETH-21, FRAGRANCE, DICAPRYLYL CARBONATE, CYCLOPENTASILOXANE, BENZYL ALCOHOL, TRICLOSAN, CYCLOHEXASILOXANE, TETRASODIUM EDTA, BISABOLOL, LINALOOL, d-LIMONENE, HEXYL CINNAMAL, BENZYL SALICYLATE, BUTYLPHENYL METHYLPROPIONAL, COUMARIN, CITRONELLOL, EUGENOL, CITRAL, ALPHA-ISOMETHYL IONONE, GERANIOL.

  • SPL UNCLASSIFIED SECTION

    Dist. by Ventura Corp, Ltd., San Juan, Puerto Rico
    00926

  • PRINCIPAL DISPLAY PANEL - 50 ml Bottle Label

    NITRO
    Desodorante Antitranspirante Roll On FM

    cy°zone 50 ml e (1.7 fl.oz.)

    PRINCIPAL DISPLAY PANEL - 50 ml Bottle Label
  • INGREDIENTS AND APPEARANCE
    CYZONE NITRO DESODORANTE ANTITRANSPIRANTE ROLL-ON FM 
    aluminum sesquichlorohydrate emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-963
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALUMINUM SESQUICHLOROHYDRATE (UNII: UCN889409V) (ALUMINUM SESQUICHLOROHYDRATE - UNII:UCN889409V) ALUMINUM SESQUICHLOROHYDRATE0.136 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    STEARETH-2 (UNII: V56DFE46J5)  
    PPG-15 STEARYL ETHER (UNII: 1II18XLS1L)  
    STEARETH-21 (UNII: 53J3F32P58)  
    DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    TRICLOSAN (UNII: 4NM5039Y5X)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
    BENZYL SALICYLATE (UNII: WAO5MNK9TU)  
    BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)  
    COUMARIN (UNII: A4VZ22K1WT)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    EUGENOL (UNII: 3T8H1794QW)  
    CITRAL (UNII: T7EU0O9VPP)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    GERANIOL (UNII: L837108USY)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-963-0150 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/11/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35007/11/2016
    Labeler - Ventura Corporation LTD (602751344)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bel Star S.A. (Colombia)880160197MANUFACTURE(13537-963)

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