Label: ALTHEUS FOR MEN- 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 September 23, 2011

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients

    Aluminum sesquichlorohydrate (17%)

  • Purpose

    Antiperspirant

  • Uses

    • reduces underarm wetness.
  • Warnings

    • For external use only.

    • Do not use on broken skin.

    • Stop use and ask a doctor if rash and irritation occurs.

    • Ask a doctor before use if you have kidney disease.

    • 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), ppg-15 stearyl ether, steareth-2, cyclopentasiloxane, steareth-21, fragrance, cyclohexasiloxane, dicaprylyl carbonate, triclosan, benzalkonium chloride, tetrasodium edta, methylparaben, bisabolol.

  • SPL UNCLASSIFIED SECTION

    Dist. by Ventura International Ltd.
    San Francisco, CA 94111.

  • PRINCIPAL DISPLAY PANEL - 50 ml Bottle Label

    ALTHEUS
    FOR MEN

    ANTIPERSPIRANT
    ROLL-ON DEODORANT
    does not contain alcohol

    ēsika

    50 ml e (1.7 fl.oz.)

    Principal Display Panel - 50 ml Bottle Label
  • INGREDIENTS AND APPEARANCE
    ALTHEUS   FOR MEN
    aluminum sesquichlorohydrate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-033
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Aluminum Sesquichlorohydrate (UNII: UCN889409V) (Aluminum Sesquichlorohydrate - UNII:UCN889409V) Aluminum Sesquichlorohydrate0.17 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    steareth-2 (UNII: V56DFE46J5)  
    cyclomethicone 5 (UNII: 0THT5PCI0R)  
    steareth-21 (UNII: 53J3F32P58)  
    cyclomethicone 6 (UNII: XHK3U310BA)  
    dicaprylyl carbonate (UNII: 609A3V1SUA)  
    triclosan (UNII: 4NM5039Y5X)  
    benzalkonium chloride (UNII: F5UM2KM3W7)  
    edetate sodium (UNII: MP1J8420LU)  
    methylparaben (UNII: A2I8C7HI9T)  
    levomenol (UNII: 24WE03BX2T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-033-0150 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35009/23/2011
    Labeler - Ventura Corporation LTD. (602751344)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bel Star S.A. (Colombia)880160197MANUFACTURE
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