Label: ALLOY ANTIPERSPIRANT AND DEODORANT- aluminum zirconium tetrachlorohydrex gly stick

  • NDC Code(s): 54473-151-01, 54473-151-02
  • Packager: Melaleuca, Inc
  • Category: HUMAN OTC DRUG LABEL

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Drug Label Information

Updated January 4, 2023

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  • ACTIVE INGREDIENT

    Active ingredient
    Aluminum zirconium tetrachlorohydrex-gly 17.8%

  • PURPOSE

    Purpose
    Antiperspirant

  • INDICATIONS & USAGE

    Use reduces underarm perspiration

  • WARNINGS

    Warnings
    For external use only

  • DO NOT USE

    Do not use on broken skin

  • ASK DOCTOR

    Ask a doctor before use if you have kidney disease

  • STOP USE

    Stop use and ask a doctor 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.

  • DOSAGE & ADMINISTRATION

    Directions

    • turn dial to raise product
    • apply 2 - 3 passes to underarms only
  • STORAGE AND HANDLING

    Other information do not freeze or store above 115°F (46°C)

  • INACTIVE INGREDIENT

    Inactive ingredients
    Aloe barbadensis leaf juice, Camellia sinensis leaf extract, cyclopentasiloxane, fragrance, hydrogenated castor oil, PEG-8 distearate, PPG-14 butyl ether, sodium bicarbonate, stearyl alcohol, talc, tocopherol, Zea mays (corn) starch

  • PRINCIPAL DISPLAY PANEL

    image of label

  • PRINCIPAL DISPLAY PANEL

    image of trial label

  • INGREDIENTS AND APPEARANCE
    ALLOY  ANTIPERSPIRANT AND DEODORANT
    aluminum zirconium tetrachlorohydrex gly stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54473-151
    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 GLY11.39 g  in 64 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
    PEG-8 DISTEARATE (UNII: 7JNC8VN07M)  
    PPG-14 BUTYL ETHER (UNII: R199TJT95T)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    TALC (UNII: 7SEV7J4R1U)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54473-151-0264 g in 1 APPLICATOR; Type 0: Not a Combination Product01/01/2018
    2NDC:54473-151-0112 g in 1 APPLICATOR; Type 0: Not a Combination Product01/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35005/01/2007
    Labeler - Melaleuca, Inc (139760102)
    Establishment
    NameAddressID/FEIBusiness Operations
    VFF833164242manufacture(54473-151)