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:
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Updated November 27, 2017
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- SPL UNCLASSIFIED SECTION
DIRECTIONS FOR USE
REF 10808 – Hemoban – 1oz/30mLClose
For dental use only.
USA: Rx only.
- 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.Close
- 2. INDICATIONS
Indicated for the control of minor hemorrhage during dental restorative procedures.Close
- 3. CONTRAINDICATIONS
This product should not be used with individuals with known sensitivities to aluminum chloride.Close
- 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.Close
- 5. WARNINGS
Do not swallow. Keep out of reach of children. For professional dental use only.Close
- 6. DOSAGE AND ADMINISTRATION
- Dispense a small amount of Hemoban into a clean dappen dish or disposable cup.
- 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.
- 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.
- 7. STORAGE
Store between 59°-86°F (15°-30°C). Protect from freezing.Close
- PRINCIPAL DISPLAY PANEL - 30 mL Bottle Label
- INGREDIENTS AND APPEARANCE
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)