Label: DURADRY PM- aluminum chloride hexahydrate gel

  • NDC Code(s): 69990-100-01, 69990-100-02
  • Packager: Novadore USA, LLC
  • 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 December 18, 2019

If you are a consumer or patient please visit this version.

  • Active ingredient

    ALUMINUM CHLORIDE HEXAHYDRATE 15%

  • Purpose

    Antiperspirant

  • Uses

    Reduces underarm perspiration

  • Warnings

    For external use only
    Stop use if rash or irritation occurs.

  • Do not use

    • On broken, irritated or recently shaved skin.
    • Immediately after bathing.
    • In or near eyes. If contact occurs, rise eyes thoroughly with water.
  • 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.

  • Directions

    • Apply to underarms only.
    • Skin must be clean and completely dry.
    • Apply a small amount of product to underarms at bedtime. It may itch during initial application.
    • The next morning, rinse underarms with abundant water and apply a regular antiperspirant. For best results, use DURADRY® AM.
    • Apply DURADRY® PM for a few nights in a row or until the excessive perspiration is controlled. Then Apply twice a week or as needed for maintenance.
  • Inactive ingredients

    Aqua, Propylene Glycol, Xanthan Gum, Sodium Bicarbonate,Disodium EDTA, Salicylic Acid.

  • Questions?

    Visit us at www.duradry.com

    Distributed by:
    NOVADORE USA, INC
    Miami, FL

  • DURADRY PM (ALUMINUM CHLORIDE HEXAHYDRATE)

    Duradry PM

    Duradry PM 10.5mL

  • INGREDIENTS AND APPEARANCE
    DURADRY PM 
    aluminum chloride hexahydrate gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69990-100
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALUMINUM CHLORIDE (UNII: 3CYT62D3GA) (ALUMINUM CATION - UNII:3XHB1D032B) ALUMINUM CHLORIDE150 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SALICYLIC ACID (UNII: O414PZ4LPZ)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    WATER (UNII: 059QF0KO0R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69990-100-011 in 1 CARTON01/01/2015
    150 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product
    2NDC:69990-100-021 in 1 CARTON02/20/2018
    210.5 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35001/01/2015
    Labeler - Novadore USA, LLC (079777451)
    Registrant - Novadore USA, LLC (079777451)
    Establishment
    NameAddressID/FEIBusiness Operations
    Novadore USA, LLC079777451label(69990-100)