Hemoban
Aluminum Chloride
Dentsply Llc, Professional Division Trading As "sultan Healthcare"
Human Prescription Drug
NDC 0699-1081Hemoban also known as Aluminum Chloride is a human prescription drug labeled by 'Dentsply Llc, Professional Division Trading As "sultan Healthcare"'. National Drug Code (NDC) number for Hemoban is 0699-1081. This drug is available in dosage form of Solution. The names of the active, medicinal ingredients in Hemoban drug includes Aluminum Chloride Anhydrous - 250 mg/g . The currest status of Hemoban drug is Active.
Drug Information:
| Drug NDC: | 0699-1081 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Hemoban |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Prescription Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Aluminum Chloride |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Dentsply Llc, Professional Division Trading As "sultan Healthcare" |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Solution |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | ALUMINUM CHLORIDE ANHYDROUS - 250 mg/g
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | DENTAL
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | UNAPPROVED DRUG OTHER |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
| Marketing Start Date: | 19 Feb, 1963 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 21 Dec, 2025 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | Dentsply LLC, Professional Division Trading as "Sultan Healthcare"
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 966557
966559
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UNII: | LIF1N9568Y
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 0699-1081-01 | 35.6 g in 1 BOTTLE, GLASS (0699-1081-01) | 19 Feb, 1963 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Product Elements:
Hemoban aluminum chloride aluminum chloride anhydrous aluminum cation water
Indications and Usage:
2. indications indicated for the control of minor hemorrhage during dental restorative procedures.
Warnings:
5. warnings do not swallow. keep out of reach of children. for professional dental use only.
Contraindications:
3. contraindications this product should not be used with individuals with known sensitivities to aluminum chloride.
Adverse Reactions:
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 â 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.
Description:
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.
Package Label Principal Display Panel:
Principal display panel - 30 ml bottle label 30 ml bottle label