Label: SURE ORIGINAL SOLID POWDER- 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 August 20, 2021

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  • SPL UNCLASSIFIED SECTION

    SURe ®
    48hr CONFIDENCE
    POWDER FRESH
    original solid
    ANTI-PERSPIRANT & DEODORANT
    Net Wt 2.7oz (76g)


    Drug Facts

  • Active Ingredient

    Aluminum Zirconium Trichlorohydrex GLY 16% (anhydrous)

  • Purpose

    Antiperspirant

  • Uses

    Reduces underarm wetness

  • Warnings

    For external use only.

  • Do not use

    On broken skin

  • Ask a doctor before use if you have

    Kidney disease

  • Stop use 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

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

  • Questions? 1 800 487-7273

    www.suredeodorant.com

    © Idelle Labs, Ltd. All rights reserved.
    Made in CANADA. Distributed by Idelle Labs, Ltd.,
    El Paso, TX 79912 USA
    Sure ® is a trademark of Kaz Europe Sarl.

  • PRINCIPAL DISPLAY PANEL

    principal display panel
  • INGREDIENTS AND APPEARANCE
    SURE ORIGINAL SOLID POWDER 
    aluminum zirconium tricholorohydrex gly stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41595-5516
    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)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41595-5516-176 g in 1 CANISTER; Type 0: Not a Combination Product12/22/2009
    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
    KDC/ONE Development Corporation, Inc.204006464manufacture(41595-5516) , analysis(41595-5516) , label(41595-5516) , pack(41595-5516)
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