Thursday, September 29, 2016

Hemoban





Dosage Form: solution
Hemoban

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.



SultanHealthcare

411 Hackensack Avenue, 9th Floor, Hackensack, NJ 07601

Toll Free: 800-637-8582 • Phone: 201-871-1232

Fax: 201-871-0321 • www.sultanhealthcare.com


Made in the USA

Form #0010801DF (R 7/22/09)



PRINCIPAL DISPLAY PANEL - 1 Gallon Bottle Label


Sultan®


REF 10802


Hemoban

Topical Hemostatic Solution


Directions: Soak cotton tip applicator pr pledget of cotton with Hemoban.

Apply to bleeding area with pressure until hemorrhage is arrested.

(NOTE: Should a small dark coagulum appear, flush away with water.

This will have no effect on hemostatic action.)


Warning: Corrosive. Consult MSDS for more information.

Each gram contains 250mg. Aluminum Chloride in 750mg. aqueous vehicle.

Contains no Epinephrine.


Manufactured for:

SultanHealthcare

411 Hackensack Avenue, 9th Floor, Hackensack, NJ 07601

Toll Free: 800-637-8582 • Phone: 201-871-1232

Fax: 201-871-0321 • www.sultanhealthcare.com


Net Contents:

1 gallon (3.8L)


Rx Only

For Dental Use Only


LOT

EXP


Made in USA

0010802LA (R 7/23/09)










Hemoban 
aluminum chloride  solution










Product Information
Product TypeHUMAN PRESCRIPTION DRUGNDC Product Code (Source)0699-1082
Route of AdministrationDENTALDEA Schedule    








Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Aluminum Chloride (Aluminum Cation)Aluminum Chloride250 mg  in 1 g






Inactive Ingredients
Ingredient NameStrength
Water 


















Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains      










Packaging
#NDCPackage DescriptionMultilevel Packaging
10699-1082-084490.9 g In 1 BOTTLE, GLASSNone










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER02/19/1963







Hemoban 
aluminum chloride  solution










Product Information
Product TypeHUMAN PRESCRIPTION DRUGNDC Product Code (Source)0699-1081
Route of AdministrationDENTALDEA Schedule    








Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Aluminum Chloride (Aluminum Cation)Aluminum Chloride250 mg  in 1 g






Inactive Ingredients
Ingredient NameStrength
Water 


















Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains      










Packaging
#NDCPackage DescriptionMultilevel Packaging
10699-1081-0135.6 g In 1 BOTTLE, GLASSNone










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER02/19/1963


Labeler - DSHealthcare (056296981)









Establishment
NameAddressID/FEIOperations
DENTSPLY Caulk083235549MANUFACTURE
Revised: 02/2010DSHealthcare



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