Label: ANTI-PERSPIRANT DEODORANT- aluminium zirconium tetrachlorohydrex gly liquid

  • NDC Code(s): 74553-001-01
  • Packager: Xtreme Tools International, Inc
  • 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 October 6, 2020

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  • Active Ingredient

    Aluminium Zirconium Tetrachlorohydrex Gly (15%)

  • Purpose

    Antiperspirant

  • Use

    Reduces underarm wetness

  • Warnings

    For external use only.

  • DO NOT USE

    Do not use on broken skin.

  • STOP USE

    Stop use and Ask Doctor if rash or irritation occurs.

  • ASK DOCTOR

    ​ Ask a doctor before use if you have kidney disease.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center right away.

  • Directions

    Apply to underarms only.

  • Inactive Ingredients

    Brassica Glycerides, Polyester-4, C 13-16 lsoparaffin, Heptyl Undecylenate, Cyclotetrasiloxane. Caprylic/Capric Triglyceride, PPG-14 Butyl Ether, Stearyl Alcohol, Fragrance

  • Questions or comments?

    Call 1-305-622-7474 Monday through Friday 9:00 AM to 5:00 PM

  • Principal Display Panel

    59 mL in Bottle; NDC 74553-001-01

    Deo

  • INGREDIENTS AND APPEARANCE
    ANTI-PERSPIRANT DEODORANT 
    aluminium zirconium tetrachlorohydrex gly liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74553-001
    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 GLY15 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CYCLOMETHICONE 4 (UNII: CZ227117JE)  
    TRICAPRIN (UNII: O1PB8EU98M)  
    PPG-14 BUTYL ETHER (UNII: R199TJT95T)  
    POLYESTER (ADIPIC ACID, 1,6-HEXANEDIOL, NEOPENTYL GLYCOL) (UNII: 571593769G)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    C13-16 ISOPARAFFIN (UNII: LED42LZG6O)  
    BRASSICA JUNCEA SEED OIL (UNII: 4D13WHP5F7)  
    HEPTYL UNDECYLENATE (UNII: W77QUB6GXO)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74553-001-0159 mL in 1 BOTTLE; Type 0: Not a Combination Product10/06/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35010/06/2020
    Labeler - Xtreme Tools International, Inc (125398904)
    Registrant - Xtreme Tools International, Inc (125398904)
    Establishment
    NameAddressID/FEIBusiness Operations
    Xtreme Tools International, Inc125398904manufacture(74553-001)
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