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NDC 00699-1081-01 Hemoban 250 mg/g Details

Hemoban 250 mg/g

Hemoban is a DENTAL SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Dentsply LLC, Professional Division Trading as "Sultan Healthcare". The primary component is ALUMINUM CHLORIDE ANHYDROUS.

Product Information

NDC	00699-1081
Product ID	0699-1081_8a5fff25-5e0a-4ebc-91db-792171cc3f1f
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Hemoban
Proprietary Name Suffix	n/a
Non-Proprietary Name	Aluminum Chloride
Product Type	HUMAN PRESCRIPTION DRUG
Dosage Form	SOLUTION
Route	DENTAL
Active Ingredient Strength	250
Active Ingredient Units	mg/g
Substance Name	ALUMINUM CHLORIDE ANHYDROUS
Labeler Name	Dentsply LLC, Professional Division Trading as "Sultan Healthcare"
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	UNAPPROVED DRUG OTHER
Application Number	n/a
Listing Certified Through	2023-12-31

Package

Package Images

NDC 00699-1081-01 (00699108101)

Pricing Information	N/A
NDC Package Code	0699-1081-01
Billing NDC	00699108101
Package	35.6 g in 1 BOTTLE, GLASS (0699-1081-01)
Marketing Start Date	1963-02-19
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 7054c4ea-fee2-4627-aff2-e99ceb1080c7 Details

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

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.

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALUMINUM CHLORIDE ANHYDROUS (UNII: LIF1N9568Y) (ALUMINUM CATION - UNII:3XHB1D032B)	ALUMINUM CHLORIDE ANHYDROUS	250 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0699-1081-01	35.6 g in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	02/19/1963

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
UNAPPROVED DRUG OTHER		02/19/1963

Labeler - Dentsply LLC, Professional Division Trading as "Sultan Healthcare" (167087753)

Name	Address	ID/FEI	Business Operations
Establishment
Dentsply Caulk		083235549	MANUFACTURE(0699-1081)

Revised: 1/2022

Document Id: 8a5fff25-5e0a-4ebc-91db-792171cc3f1f

Set id: 7054c4ea-fee2-4627-aff2-e99ceb1080c7

Version: 4

Effective Time: 20220118