Label: ESIKA D ARIEN CLASS ROLL-ON- aluminum sesquichlorohydrate liquid

  • NDC Code(s): 13537-438-01
  • Packager: Ventura Corporation LTD.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 02/13

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active Ingredient

    Aluminum sesquichlorohydrate 13.6 %

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  • Purpose

    Antiperspirant

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  • Uses

    • Reduces underarm perspiration
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  • 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.

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  • Directions

    • Apply to underarms only.
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  • 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.

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  • SPL UNCLASSIFIED SECTION

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

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  • PRINCIPAL DISPLAY PANEL - 50 ml Bottle Label

    D'ARIEN
    CLASS

    ANTIPERSPIRANT
    ROLL-ON DEODORANT
    does not contain alcohol

    ésika

    50 ml e (1.7 fl.oz.)

    Principal Display Panel - 50 ml Bottle Label
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  • INGREDIENTS AND APPEARANCE
    ESIKA   D ARIEN CLASS ROLL-ON
    aluminum sesquichlorohydrate liquid
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-438
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Aluminum Sesquichlorohydrate (UNII: UCN889409V) (Aluminum Sesquichlorohydrate - UNII:UCN889409V) Aluminum Sesquichlorohydrate 0.136 g  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    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)  
    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 Code Package Description Marketing Start Date Marketing End Date
    1 NDC:13537-438-01 50 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part350 02/01/2013
    Labeler - Ventura Corporation LTD. (602751344)
    Establishment
    Name Address ID/FEI Business Operations
    Bel Star S.A. (Colombia) 880160197 MANUFACTURE(13537-438)
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