Hemoban

HEMOBAN- aluminum chloride anhydrous solution
Dentsply LLC, Professional Division Trading as “Sultan Healthcare”

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.

DIRECTIONS FOR USE

REF 10808 – Hemoban – 1oz/30mL
NPN 00638331
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.

2. INDICATIONS

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

3. CONTRAINDICATIONS

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

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.

5. WARNINGS

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

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.

7. STORAGE

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

PRINCIPAL DISPLAY PANEL — 30 mL Bottle Label

HEMOBAN aluminum chloride solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0699-1081 Route of Administration DENTAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALUMINUM CHLORIDE ANHYDROUS (ALUMINUM CATION) ALUMINUM CHLORIDE ANHYDROUS 250 mg in 1 g

Inactive Ingredients Ingredient Name Strength WATER

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0699-1081-01 35.6 g in 1 BOTTLE, GLASS None

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	Operations
Dentsply Caulk		083235549	MANUFACTURE (0699-1081)

Revised: 01/2022 Dentsply LLC, Professional Division Trading as “Sultan Healthcare”