Label: ESIKA WINNER SPORT ANTIPERSPIRANT ROLL-ON DEODORANT- aluminum sesquichlorohydrate emulsion

  • NDC Code(s): 14141-200-01
  • Packager: Bel Star S.A. (Colombia)
  • 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 June 16, 2022

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  • ACTIVE INGREDIENT

    Active Ingredient Purpose

    Aluminum sesquichlorohydrate 13.60% Antiperspirant

  • PURPOSE

    Uses

    • reduces underarm perspiration
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • INDICATIONS & USAGE

    Stop use if rash or irritation occurs

  • WARNINGS

    Warnings

    For external use only

    Do not use on broken skin

    Ask a doctor before use if you have kidney disease

  • DOSAGE & ADMINISTRATION

    Directions

    Apply to underarms only

  • INACTIVE INGREDIENT

    Inactive Ingredients:

    water, steareth-2,ppg-15 stearyl ether, steareth-21, cyclohexasiloxane, fragrance, dicaprylyl carbonate, benzyl alcohol, 2-methyl 5-cyclohexylpentanol, hydroxyacetophenone, tetrasodium edta, bisabolol, linalool, hexyl cinnamal, limonene, benzyl salicylate, isoeugenol, coumarin, citral, benzyl benzoate, eugenol, geraniol.

  • PRINCIPAL DISPLAY PANEL

    Esika Winner Sport Antiperspirant Roll-on Deodorant

    1.6 fl. oz./ 50 ml

    1

  • INGREDIENTS AND APPEARANCE
    ESIKA WINNER SPORT ANTIPERSPIRANT ROLL-ON DEODORANT 
    aluminum sesquichlorohydrate emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14141-200
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALUMINUM SESQUICHLOROHYDRATE (UNII: UCN889409V) (ALUMINUM SESQUICHLOROHYDRATE - UNII:UCN889409V) ALUMINUM SESQUICHLOROHYDRATE13.6 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    STEARETH-2 (UNII: V56DFE46J5)  
    BENZYL BENZOATE (UNII: N863NB338G)  
    EUGENOL (UNII: 3T8H1794QW)  
    CITRAL (UNII: T7EU0O9VPP)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
    GERANIOL (UNII: L837108USY)  
    BENZYL SALICYLATE (UNII: WAO5MNK9TU)  
    ISOEUGENOL (UNII: 5M0MWY797U)  
    COUMARIN (UNII: A4VZ22K1WT)  
    2-METHYL 5-CYCLOHEXYLPENTANOL (UNII: 460837ILID)  
    DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    PPG-15 STEARYL ETHER (UNII: 1II18XLS1L)  
    STEARETH-21 (UNII: 53J3F32P58)  
    LINALOOL, (+)- (UNII: F4VNO44C09)  
    WATER (UNII: 059QF0KO0R)  
    HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:14141-200-0150 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/07/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM01910/07/2020
    Labeler - Bel Star S.A. (Colombia) (880160197)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bel Star S.A. (Colombia)880160197manufacture(14141-200)
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