Label: HEMOBAN- aluminum chloride solution

  • NDC Code(s): 0699-1081-01
  • Packager: Dentsply LLC, Professional Division Trading as "Sultan Healthcare"
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status:

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 November 27, 2017

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  • SPL UNCLASSIFIED SECTION

    DIRECTIONS FOR USE

    REF 10808 – Hemoban – 1oz/30mL
    NPN 00638331
    For dental use only.
    USA: Rx only.

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  • 1. DESCRIPTION

    Hemoban is formulated to control minor hemorrhage during dental restorative procedures. Hemoban may be used on a cotton pellet or more commonly with retraction cord. Hemoban contains 25% aluminum chloride.

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  • 2. INDICATIONS

    Indicated for the control of minor hemorrhage during dental restorative procedures.

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  • 3. CONTRAINDICATIONS

    This product should not be used with individuals with known sensitivities to aluminum chloride.

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  • 4. PRECAUTIONS

    Use only as directed. Hemoban may interfere with the setting reactions of dental materials, specifically addition-type (VPS) silicone impression materials. To prevent a setting failure, gently rinse the tissue after the hemostasis has been achieved.

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  • 5. WARNINGS

    Do not swallow. Keep out of reach of children. For professional dental use only.

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  • 6. DOSAGE AND ADMINISTRATION

    1. Dispense a small amount of Hemoban into a clean dappen dish or disposable cup.
    2. For hemorrhage control prior to making a restorative impression, soak a suitable length of retraction cord in Hemoban, then using a cord-packing instrument, place the retraction cord into the gingival sulcus. Hemoban is compatible with all impression techniques – though it is recommended that critical areas be gently rinsed with water prior to application of addition-type (VPS) impression materials to preclude inhibition of the setting reaction of the impression material.
    3. For minor hemorrhage control in situations other than making restorative impressions, soak a cotton pellet in Hemoban and apply for several seconds to the area, then rinse gently with water.
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  • 7. STORAGE

    Store between 59°-86°F (15°-30°C). Protect from freezing.

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  • PRINCIPAL DISPLAY PANEL - 30 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    HEMOBAN 
    aluminum chloride solution
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0699-1081
    Route of Administration DENTAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ALUMINUM CHLORIDE ANHYDROUS (UNII: LIF1N9568Y) (ALUMINUM CATION - UNII:3XHB1D032B) ALUMINUM CHLORIDE ANHYDROUS 250 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0699-1081-01 35.6 g in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 02/19/1963
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 02/19/1963
    Labeler - Dentsply LLC, Professional Division Trading as "Sultan Healthcare" (167087753)
    Establishment
    Name Address ID/FEI Business Operations
    DENTSPLY Caulk 083235549 manufacture(0699-1081)
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