Label: OSCAR ANTI PERSPIRANT DEODORANT- aluminum zirconium trichlorohydrex gly stick

  • NDC Code(s): 58443-0320-3
  • Packager: Prime Enterprises, 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 11, 2020

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  • Active ingredients

    ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 20%

  • Purpose

    Anti-Perspirant

  • Use: Reduces underarm perspiration

  • Warnings: For external use only.

    Do not use on damaged or broken skin. Stop use if rash or irritation occurs. Ask a doctor before use if you have kidney disease.

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

  • DOSAGE & ADMINISTRATION

    Directions: Apply to underarms only

  • Inactive Ingredients

    Cyclopentasiloxane, Behenyl Alcohol, Mineral Oil, Stearyl Alcohol, C10-18 Triglycerides, PEG-8 Distearate, Fragrance, Hydrogenated Castor Oil, Ethylhexyl Palmitate, Tribehenin, Glyceryl Stearate, Talc, PEG-100 Stearate

  • PRINCIPAL DISPLAY PANEL - 75 g Stick Label

    PRINCIPAL DISPLAY PANEL - 75 g Stick Label

    Oscar

    ANTI-PERSPIRANT DEODORANT

    DÉODORANT ANTI-PERSPIRANT

    NET Wt. 2.5 oz. 75g e

  • INGREDIENTS AND APPEARANCE
    OSCAR  ANTI PERSPIRANT DEODORANT
    aluminum zirconium trichlorohydrex gly stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58443-0320
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY (UNII: T27D6T99LH) (ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY - UNII:T27D6T99LH) ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY0.2 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    HYDROGENATED PALM KERNEL GLYCERIDES (UNII: UM8Y22J4JW)  
    C10-18 TRIGLYCERIDES (UNII: 43AGM4PHPI)  
    PEG-8 DISTEARATE (UNII: 7JNC8VN07M)  
    HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    TRIBEHENIN (UNII: 8OC9U7TQZ0)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    TALC (UNII: 7SEV7J4R1U)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58443-0320-375 g in 1 CANISTER; Type 0: Not a Combination Product11/05/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35011/05/2015
    Labeler - Prime Enterprises, Inc. (101946028)
    Registrant - Prime Enterprises, Inc. (101946028)
    Establishment
    NameAddressID/FEIBusiness Operations
    Prime Enterprises, Inc.101946028label(58443-0320) , pack(58443-0320) , manufacture(58443-0320) , analysis(58443-0320)
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