Label: SURE ORIGINAL SOLID FRESH SCENT- aluminum zirconium tricholorohydrex gly stick

  • 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 May 10, 2012

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  • SPL UNCLASSIFIED SECTION

    Sure Original Solid Fresh Scent
    Aluminum Zirconium Trichlorohydrex GLY
    Anti-perspirant and Deodorant
    MM1
  • Active Ingredient

    Aluminum Zirconium Trichlorohydrex GLY 16% (anhydrous)

  • Purpose

    Antiperspirant

  • Uses

    Reduces underarm wetness

  • Warnings

    For external use only.

  • Do not use

    Do not use on broken skin

  • Ask a doctor

    Ask a doctor before use if you have kidney disease

  • Stop use

    Stop use if rash or irritation occurs

  • 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.

  • Directions

    Apply to underarms only

  • Inactive Ingredients

    Cyclopentasiloxane, Stearyl Alcohol, Talc, Dimethicone, Hydrogenated Castor Oil, Fragrance, Polyethylene, Silica, Dipropylene Glycol, Behenyl Alcohol

  • Questions

    1-800-944-4477
    www.suredeodorant.com

    © Idelle Labs, Ltd.  All rights reserved
    Made in Canada and distributed by Idelle Labs, Ltd., El Paso, TX 79912
    Sure® is a registered trademark of Helen of Troy Limited

  • PRINCIPAL DISPLAY PANEL

    principal display panel

    label

  • INGREDIENTS AND APPEARANCE
    SURE ORIGINAL SOLID FRESH SCENT 
    aluminum zirconium tricholorohydrex gly stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41595-5515
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY (UNII: T27D6T99LH) (ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY - UNII:T27D6T99LH) ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY16 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    TALC (UNII: 7SEV7J4R1U)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
    LOW DENSITY POLYETHYLENE (UNII: J245LN42AI)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41595-5515-176 g in 1 CANISTER
    2NDC:41595-5515-293 g in 1 CANISTER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35012/22/2009
    Labeler - Idelle Labs, Ltd (128822926)
    Registrant - Idelle Labs, Ltd (128822926)
    Establishment
    NameAddressID/FEIBusiness Operations
    Body Blue 2006 Inc.243094112MANUFACTURE
    Establishment
    NameAddressID/FEIBusiness Operations
    Les Emballages Knowlton, Inc.248704645MANUFACTURE
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