SURE ORIGINAL SOLID REGULAR (ALUMINUM ZIRCONIUM TRICHOLOROHYDREX GLY) STICK [IDELLE LABS, LTD]

SURE ORIGINAL SOLID REGULAR (ALUMINUM ZIRCONIUM TRICHOLOROHYDREX GLY) STICK [IDELLE LABS, LTD]
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NDC 41595-5514-1, 41595-5514-2
Set ID adfa4186-196e-4b8b-957e-9d1ad776b328
Category HUMAN OTC DRUG LABEL
Packager Idelle Labs, Ltd
Generic Name
Product Class
Product Number
Application Number PART350
  • SPL UNCLASSIFIED SECTION

    SURe ®
    48hr CONFIDENCE
    REGULAR
    original solid
    ANTI-PERSPIRANT & DEODORANT
    Net Wt 1.7 oz (48g)


    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient

    Aluminum Zirconium Trichlorohydrex GLY 16% (anhydrous)

  • Purpose

    Antiperspirant

  • Use

    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 and distributed by
    Idelle Labs, Ltd., El Paso, TX 79912
    Sure ® is a registered trademark of Kaz Europe Sarl

  • PRINCIPAL DISPLAY PANEL

    principal display panel-1
    principal display panel-2
  • INGREDIENTS AND APPEARANCE
    SURE ORIGINAL SOLID REGULAR 
    aluminum zirconium tricholorohydrex gly stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41595-5514
    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:41595-5514-148 g in 1 CANISTER; Type 0: Not a Combination Product12/22/2009
    2NDC:41595-5514-276 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(41595-5514) , analysis(41595-5514) , label(41595-5514) , pack(41595-5514)

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