Label: ESIKA CARDIGAN ANTIPERSPIRANT ROLL-ON DEODORANT- aluminum sesquichlorohydrate emulsion

  • 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 July 8, 2016

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Aluminum sesquichlorohydrate 13.60%

  • 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, PPG-15 STEARYL ETHER, STEARETH-2, STEARETH-21, FRAGRANCE, DICAPRYLYL CARBONATE, CYCLOPENTASILOXANE, CYCLOHEXASILOXANE,TRICLOSAN, METHYLPARABEN, TETRASODIUM EDTA, BENZALKONIUM CHLORIDE, BISABOLOL, d-LIMONENE, HEXYL CINNAMAL, EUGENOL, COUMARIN, LINALOOL, BENZYL SALICYLATE, CITRONELLOL, GERANIOL, BENZYL BENZOATE, CITRAL.

  • SPL UNCLASSIFIED SECTION

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

  • PRINCIPAL DISPLAY PANEL - 50 ml Bottle Label

    CARDIGAN

    ANTIPERSPIRANT
    ROLL-ON DEODORANT
    does not contain alcohol

    ésika

    50 ml e (1.7 fl.oz.)

    PRINCIPAL DISPLAY PANEL - 50 ml Bottle Label
  • INGREDIENTS AND APPEARANCE
    ESIKA CARDIGAN ANTIPERSPIRANT ROLL-ON DEODORANT 
    aluminum sesquichlorohydrate emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-955
    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)  
    PPG-15 STEARYL ETHER (UNII: 1II18XLS1L)  
    STEARETH-2 (UNII: V56DFE46J5)  
    STEARETH-21 (UNII: 53J3F32P58)  
    DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    TRICLOSAN (UNII: 4NM5039Y5X)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    Limonene, (+)- (UNII: GFD7C86Q1W)  
    .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
    EUGENOL (UNII: 3T8H1794QW)  
    COUMARIN (UNII: A4VZ22K1WT)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    BENZYL SALICYLATE (UNII: WAO5MNK9TU)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    GERANIOL (UNII: L837108USY)  
    BENZYL BENZOATE (UNII: N863NB338G)  
    CITRAL (UNII: T7EU0O9VPP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-955-0150 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/05/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35007/05/2016
    Labeler - Ventura Corporation LTD (602751344)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bel Star S.A. (Colombia)880160197MANUFACTURE(13537-955)
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