Label: DURADRY ANTIPERSPIRANT- aluminum zirconium trichlorohydrex gly stick

  • NDC Code(s): 58443-0534-3
  • 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 February 4, 2022

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  • Active Ingredients

    Aluminum Zirconium Trichlorohydrex Gly 20%

  • Purpose

    Antiperspirant

  • Uses

    Reduces underarm perspiration.

  • Warnings

    For external use only.

    Do not use

    on broken skin.

    Ask a doctor before use if you have

    kidney disease.

    Stop use

    if rash or irritation occurs.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center immediately.

  • Directions

    Apply to underarms only.

  • Inactive Ingredients

    C13-15 Alkane, Caprylic/Capric Triglyceride, Caprylyl Glycol, Cetyl Palmitate, Ethylhexylglycerin, Fragrance, Hydrogenated Castor Oil, Isododecane, Isohexadecane, Maranta Arundinacea (Arrowroot) Root Extract, Salvia Officinalis (Sage) Oil, Sodium Caproyl/Lauroyl Lactylate, Stearyl Alcohol, Triethyl Citrate

  • Duradry AM Deoderant & Antiperspirant Clear Sky

    Principle Display Label

  • INGREDIENTS AND APPEARANCE
    DURADRY  ANTIPERSPIRANT
    aluminum zirconium trichlorohydrex gly stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58443-0534
    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 GLY199 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    C13-15 ALKANE (UNII: 114P5I43UJ)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    MARANTA ARUNDINACEA ROOT (UNII: FVN346W31A)  
    SODIUM CAPROYL LACTYLATE (UNII: 87WR3BHC09)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    SAGE OIL (UNII: U27K0H1H2O)  
    HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
    ISODODECANE (UNII: A8289P68Y2)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CETYL PALMITATE (UNII: 5ZA2S6B08X)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    FRAGRANCE LAVENDER & CHIA F-153480 (UNII: SXS9CO2TZK)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    Product Characteristics
    Colorwhite (White to Cream Yellow) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58443-0534-365 mL in 1 CANISTER; Type 0: Not a Combination Product02/02/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35002/02/2021
    Labeler - Prime Enterprises, Inc. (101946028)
    Registrant - Prime Enterprises, Inc. (101946028)
    Establishment
    NameAddressID/FEIBusiness Operations
    Prime Enterprises, Inc.101946028manufacture(58443-0534) , label(58443-0534) , analysis(58443-0534) , pack(58443-0534)
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