Label: ESIKA TOTAL SEC ULTRA FRESH- 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 January 27, 2012

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Aluminum sesquichlorohydrate 16.2 %

  • Purpose

    Antiperspirant

  • Uses

    • Reduces underarm perspiration
    • All day extra effective protection
  • 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

    AQUA (WATER), STEARETH-2, STEARETH-21, PPG-15 STEARYL ETHER, CYCLOPENTASILOXANE, CYCLOHEXASILOXANE, PARFUM (FRAGRANCE), DICAPRYLYL CARBONATE, BISABOLOL, TRICLOSAN, BENZALKONIUM CHLORIDE, METHYLPARABEN, BHT, PROPYLENE GLYCOL, MENTHYL PCA, TETRASODIUM EDTA, MENTHOL, DIPROPYLENE GLYCOL, BAMBUSA ARUNDINACEA LEAF EXTRACT

  • SPL UNCLASSIFIED SECTION

    PR: Dist. By Ventura Corporation, Ltd. San Juan, Puerto Rico 00926.

  • PRINCIPAL DISPLAY PANEL - 50 ml Bottle Label

    ésika
    total
    sec

    ULTRA FRESH

    Alcohol-free
    Men's Roll-on
    Deodorant and
    Antiperspirant
    All day extra
    effective protection

    36

    50 ml e (1.7 fl.oz.)

    Principal Display Panel - 50 ml Bottle Label
  • INGREDIENTS AND APPEARANCE
    ESIKA   TOTAL SEC ULTRA FRESH
    aluminum sesquichlorohydrate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-156
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALUMINUM SESQUICHLOROHYDRATE (UNII: UCN889409V) (ALUMINUM SESQUICHLOROHYDRATE - UNII:UCN889409V) ALUMINUM SESQUICHLOROHYDRATE0.0162 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    STEARETH-2 (UNII: V56DFE46J5)  
    STEARETH-21 (UNII: 53J3F32P58)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    TRICLOSAN (UNII: 4NM5039Y5X)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    MENTHYL PYRROLIDONE CARBOXYLATE, (-),DL- (UNII: 8P18J856U2)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    MENTHOL (UNII: L7T10EIP3A)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    BAMBUSA ARUNDINACEA LEAF (UNII: HW86D1FGSS)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-156-0150 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35001/24/2012
    Labeler - Ventura Corporation, Ltd. (602751344)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bel Star S.A. (Colombia)880160197MANUFACTURE
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