HEMOBAN- aluminum chloride solution

Hemoban by

Drug Labeling and Warnings

Hemoban by is a Prescription medication manufactured, distributed, or labeled by Dentsply LLC, Professional Division Trading as "Sultan Healthcare", Dentsply Caulk. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

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)