Label: OKAY WOMENS ALUMINIUM FREE DEODORANT STICK- aluminum zirconium tetrachlorohydrex gly stick

  • NDC Code(s): 74553-008-01, 74553-008-02
  • 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 May 14, 2021

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  • Active Ingredient

    Aluminum Zirconium Tetrachlorohydrex GLY (20%)………………….................Purpose: Antiperspirant

  • Purpose

    Antiperspirant

  • Uses

    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 a Poison Control Center right away.

  • Directions

    Apply to underarms only.

  • Inactive Ingredients

    Cyclopentasiloxane,Cetearyl Alcohol, PPG-14-Butyl Ether, HydroxypropylStarch Phosphate, Propylene Glycol, Glyceryl Stearate, PEG-100 Stearate, Myristyl Myristate, Silica Dimethyl Silylate, Cetyl Ricinoleate, PEG-40-Hydrogenated Castor Oil, Fragrance.

  • Questions or comments?

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

  • Package Label

    56 gr (2oz) in Twist up Tube (NDC 74553-008-01)

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  • Package Label

    85 gr (3oz) in Twist up Tube (NDC 74553-008-02)

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  • INGREDIENTS AND APPEARANCE
    OKAY WOMENS ALUMINIUM FREE DEODORANT STICK 
    aluminum zirconium tetrachlorohydrex gly stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74553-008
    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 GLY20 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    PPG-14 BUTYL ETHER (UNII: R199TJT95T)  
    HYDROXYPROPYL DISTARCH PHOSPHATE, HIGH AMYLOSE CORN (UNII: 9F8ET54T05)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    MYRISTYL MYRISTATE (UNII: 4042ZC00DY)  
    SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
    CETYL RICINOLEATE (UNII: 1P677500YD)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74553-008-0156 g in 1 TUBE; Type 0: Not a Combination Product05/14/2021
    2NDC:74553-008-0285 g in 1 TUBE; Type 0: Not a Combination Product05/14/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35005/14/2021
    Labeler - Xtreme Tools International, Inc (125398904)
    Registrant - Xtreme Tools International, Inc (125398904)
    Establishment
    NameAddressID/FEIBusiness Operations
    Xtreme Tools International, Inc125398904manufacture(74553-008)
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