Label: BIO-STRIKE ANTIPERSPIRANT/DEODORANT- aluminum zirconium trichlorohydrex 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 January 8, 2020

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Aluminum Zirconium Trichlorohydrex Gly 20%

  • PURPOSE

    Anti-perspirant

  • Use

    Reduces underarm wetness. Extra effective.

  • WARNINGS

    For external use only. Do not use on broken skin. Ask a doctor before use if you have a 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

    Turn dial 2 clicks to raise product. Apply to underarms only.

  • OTHER INFORMATION

    Avoid storage at extreme temperatures (below 35˚F and above 115˚F).

  • INACTIVE INGREDIENTS

    Cyclopentasiloxane, Dimethicone/Vinyl Dimethicone Crosspolymer, Hydrogenated Castor Oil, Talc, Dimethicone, Polyethylene, Water, Sodium Borate, Silver Nitrate.

  • Questions or Comments?

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  • SPL UNCLASSIFIED SECTION

    Distributed by Hunters Specialties, Inc.[6000 Huntington Ct, NE]Cedar Rapids , IA 52402

  • PRINCIPAL DISPLAY PANEL - 56.6 G Canister Label

    ODOR
    SCENT-
    A-WAY®
    CONTROL

    BIO-STRIKE®
    ODOR ASSAULT FORMULA

    STRIKE ODOR AT THE SOURCE

    CLINICAL STRENGTH / ODORLESS

    ANTIPERSPIRANT/
    DEODORANT

    100025_V1

    NET WT.
    2 oz. [56.6G]

    PRINCIPAL DISPLAY PANEL - 56.6 G Canister Label
  • INGREDIENTS AND APPEARANCE
    BIO-STRIKE ANTIPERSPIRANT/DEODORANT 
    aluminum zirconium trichlorohydrex gly stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63798-821
    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 GLY200 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    Talc (UNII: 7SEV7J4R1U)  
    glycine (UNII: TE7660XO1C)  
    Sodium Borate (UNII: 91MBZ8H3QO)  
    Silver Nitrate (UNII: 95IT3W8JZE)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63798-821-0256.66 g in 1 CANISTER; Type 0: Not a Combination Product08/15/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35008/15/2017
    Labeler - Hunters Specialties, Inc. (083489971)
    Registrant - BMC 1092, Inc. dba Solo Laboratories, Inc (078831987)
    Establishment
    NameAddressID/FEIBusiness Operations
    BMC 1092, Inc. dba Solo Laboratories, Inc078831987MANUFACTURE(63798-821)
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