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

30 mL bottle label
(click image for full-size original)

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: 11/2017 Dentsply LLC, Professional Division Trading as “Sultan Healthcare”

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