Label: HELMM ANTIPERSPIRANT DEODORANT TRAILBLAZER- aluminum zirconium tetrachlorohydrex gly gel

  • 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 December 17, 2018

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  • ACTIVE INGREDIENT

    Aluminum Zirconium Tetrachlorohydren GLY (18%)

  • INACTIVE INGREDIENT

    Cyclopentasiloxane, Stearyl Alcohol, PPG-14 Butyl Ether, Cetyl Alcohol, C12-C15 Alkyl Benzoate, Dimethicone 10 CST, Hydrogenated Castor Oil, Behenyl Alcohol, Sunflower Seed Oil, Vegetable Glycerin, Tapioca Starch, Steareth-2, Corn Starch, Fragrance, Vitamin E Acetate, Aloe Leaf Extract

  • INDICATIONS & USAGE

    Uses: reduces underarm wetness

  • WARNINGS

    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.

  • 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.

  • DOSAGE & ADMINISTRATION

  • PURPOSE

    Uses: reduces underarm wetness​

  • PRINCIPAL DISPLAY PANEL

    Trailblazer

  • INGREDIENTS AND APPEARANCE
    HELMM ANTIPERSPIRANT DEODORANT TRAILBLAZER 
    aluminum zirconium tetrachlorohydrex gly gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72147-1803
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY (UNII: 8O386558JE) (ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY - UNII:8O386558JE) ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY18 g  in 57 g
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, CORN (UNII: O8232NY3SJ)  
    PPG-14 BUTYL ETHER (UNII: R199TJT95T)  
    STARCH, TAPIOCA (UNII: 24SC3U704I)  
    STEARETH-2 (UNII: V56DFE46J5)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    C12-15 ALKYL ETHYLHEXANOATE (UNII: GQJ580CH83)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    DIMETHICONE 20 (UNII: H8YMB5QY0D)  
    HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72147-1803-171 g in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product04/10/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35004/10/2018
    Labeler - ZGTL, LLC (081049362)
    Registrant - ZGTL, LLC (081049362)
    Establishment
    NameAddressID/FEIBusiness Operations
    Raining Rose083819404manufacture(72147-1803) , api manufacture(72147-1803)
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