Label: HEMOSTAT- aluminum chloride solution

  • NDC Code(s): 61509-100-18
  • Packager: Cargus International, Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated February 1, 2019

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

  • DESCRIPTION:

    Hemostat is a topical astringent solution of Aluminum Chloride. Gingival retraction can be achieved using a plain gingival retraction cord moistened with Hemostat solution.

  • PRECAUTIONS:

    Discontinue use if irritation appears. For topical application only. Avoid eye contact.

  • BENEFITS:

    Hemostat stops gingival bleeding fast. If you should inadvertantly damage the gingival margin during tooth preparation or while placing a strip, band or a cerival matrix, moisten the area with Hemostat which will control and stop bleeding quickly. Hemostat contains no epinephrine. The use of vasoconstrictors for gingival retractions and bleeding is potentially dangerous and should be avoided. A plain gingival retraction cord can be dipped in Hemostat solution and then placed into the gingival sulcus for its hemostatic action.

  • DIRECTIONS:

    Soak a cotton tipped applicator with Hemostat. Apply to bleeding area with pressure until bleeding is stopped. Should a small dark coagulum appear, flush it away with water. This will have no effect on hemostatic action. Remove the impregnated cord from sulcus. Flush with water and dry with air. If hemostasis is not achieved, repeat application, rinse with water and air dry until bleeding is no longer present.

  • CONTRAINDICATIONS:

    Do not use in patients with a known history of hyper sensitivity to aluminum chloride.

  • CAUTION:

    Keep out of reach of children.

    FOR PROFESSIONAL USE ONLY.

  • PRINCIPAL DISPLAY PANEL

    BX.Cargus Hemostatic.jpg

  • PRINCIPAL DISPLAY PANEL

    IN.CargusHemostat.jpg

  • PRINCIPAL DISPLAY PANEL

    LB.CargusHemostat.jpg

  • INGREDIENTS AND APPEARANCE
    HEMOSTAT 
    aluminum chloride solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:61509-100
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Aluminum Chloride (UNII: 3CYT62D3GA) (ALUMINUM CATION - UNII:3XHB1D032B) Aluminum Chloride7500 mg  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Potassium Chloride (UNII: 660YQ98I10)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    Product Characteristics
    Colorwhite (colorless) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61509-100-1830 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/01/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other03/01/2013
    Labeler - Cargus International, Inc. (096191093)