Label: SURE FOR MEN- invisible solid crisp breeze 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 September 18, 2009

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  • PRINCIPAL DISPLAY PANEL

    Sure for Men Invisible Solid Crisp Breeze
    MM1
    image of front label
  • Active Ingredient

    Active Ingredient

    Aluminum Zirconium Trichlorohydrex GLY 20% (anhydrous)

  • Purpose and Uses

    Purpose

    Antiperspirant

    Use

    Reduces underarm wetness

  • Warnings

    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

    Directions

    Apply to underarms only

  • Inactive Ingredients

    Inactive Ingredients

    Cyclopentasiloxane, Stearyl Alcohol, Dimethicone, Petrolatum, PPG-14 Butyl Ether, Hydrogenated Castor Oil, Talc, Fragrance, Zea Mays (Corn) Starch, Manitol, Mineral Oil, Behenyl Alcohol

  • QUESTIONS

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  • INGREDIENTS AND APPEARANCE
    SURE  FOR MEN
    invisible solid crisp breeze stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41595-5520
    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 GLY20 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    Stearyl Alcohol (UNII: 2KR89I4H1Y)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
    Talc (UNII: 7SEV7J4R1U)  
    Mineral oil (UNII: T5L8T28FGP)  
    Docosanol (UNII: 9G1OE216XY)  
    LOW DENSITY POLYETHYLENE (UNII: J245LN42AI)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41595-5520-390 g in 1 CANISTER
    2NDC:41595-5520-273 g in 1 CANISTER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35010/10/2009
    Labeler - Innovative Brands, LLC (786808134)
    Registrant - Innovative Brands, LLC (786808134)
    Establishment
    NameAddressID/FEIBusiness Operations
    Les Emballages Knowlton248704645manufacture
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