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
  • 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 February 23, 2018

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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
    VVF833164242manufacture(54473-151)
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