Label: ANTIPERSPIRANT MAXIMUM SECURITY- aluminum zirconium tetrachlorohydrex gly stick

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 05/15

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  • ACTIVE INGREDIENT

    Active ingredient Purpose

    Aluminum Zirconium tetrachlorohydrex Gly 8.6% W/W Antiperspirant

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  • PURPOSE

    Use reduces underarm perspiration

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  • 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.

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  • INDICATIONS & USAGE

    Stop use and ask a doctor if rash or irritation occurs.

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  • WARNINGS


    Warnings
    For external use only
    Do not use on broken skin

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  • DOSAGE & ADMINISTRATION

    Directions apply to underarms only

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  • INACTIVE INGREDIENT

    Inactive ingredients

    Propylene glycol, fragrance, dibenzylidene sorbitol, diisopropyl sebacate, hydroxypropyl cellulose, PEG/PPG-14/4 dimethicone, tetrasodium EDTA.

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  • PRINCIPAL DISPLAY PANEL

    Maximum Security

    Antiperspirant

    Regular

    Net WT. 2.5 oz (70g)

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  • INGREDIENTS AND APPEARANCE
    ANTIPERSPIRANT  MAXIMUM SECURITY
    aluminum zirconium tetrachlorohydrex stick
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:22431-640
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY (UNII: 8O386558JE) (ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY - UNII:8O386558JE) ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 6.02 g  in 70 g
    Inactive Ingredients
    Ingredient Name Strength
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    DIISOPROPYL SEBACATE (UNII: J8T3X564IH)  
    HYDROXYPROPYL CELLULOSE (UNII: RFW2ET671P)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:22431-640-01 70 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part350 06/07/2011
    Labeler - Blue Cross Labs (008298879)
    Registrant - Blue Cross Labs (008298879)
    Establishment
    Name Address ID/FEI Business Operations
    Ninghai Everstar 527072149 manufacture(22431-640)
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