Orostat 8%
Product Images NDC 10129-006

View Photos of Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 11 technical images submitted to the FDA as part of the official labeling for Orostat 8% (NDC 10129-006). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Gingi-pak A Division Of The Belport, these visuals offer a comprehensive scientific overview of the product's physical and chemical identity, aiding pharmacists and researchers in product verification and study.

FDA Label Image

Active Ingredient (Active Ingredient)

Active Ingredient (Active Ingredient)
This is a description of an active ingredient containing 8% of DL-Epinephrine-HCI w/w. It is not clear what product this ingredient is used in or the intended use of the product.*
FDA Label Image

Description (Description)

Description (Description)
Orostat® is a product that can be used as a retraction agent or a vasoconstrictor to control bleeding and tissue seepage in the oral area. It works fast and leaves a clean, debris-free field.*
FDA Label Image

Directions (Directions)

Directions (Directions)
The text provides instructions for using Orostat in dental procedures. Orostat can be used with cotton pellets, sponge, or syringe with tips at room temperature. It can also be soaked into unmedicated retraction cord or braid to be packed into the gingival sulcus. After several minutes, the cord should be removed, and the area should be rinsed or flushed well before taking the impression. Silicone and rubber-based impression materials should be used on dry surfaces, while wet surfaces are required for impressions. Persistent bleeding can be addressed by applying Orostat with pressure. Scrubbing or burnishing is not recommended, as it could be harmful to gingival tissue.*
FDA Label Image

Inactive Ingredients (Inactive Ingredients)

Inactive Ingredients (Inactive Ingredients)
This is a list of ingredients commonly found in a product. It includes purified water, sodium hydrosulfite, sodium thiosulfate, sodium monophosphate, sodium chloride, EDTA, methylparaben, propylparaben, and benzyl alcohol. Without knowing the product that this list pertains to, it is difficult to provide further information.*
FDA Label Image

Keep Out Of Reach If Children (Keep Out Of Children)

Keep Out Of Reach If Children (Keep Out Of Children)
This is a warning label advising that a particular item or substance should be kept away from children to prevent any harm or danger.*
FDA Label Image

Principal Display-orostat 8% (Orostat 15 Cc)

Principal Display-orostat 8% (Orostat 15 Cc)
This text appears to be a label of a product containing an Epinephrine HCI solution with buffering agents that is only intended for sale or use on the order of a dentist. The label includes information in several languages like English, German, French, Italian, and Portuguese, indicating the name of the product, the concentration of the active ingredient, the caution statement, and the contact information of the manufacturer. The purpose of the solution is not clear from the given text.*
FDA Label Image

Purpose (Purpose)

FDA Label Image

Storage (Storage)

Storage (Storage)
This is a standard storage instruction for a product. It suggests keeping the product in a cool and dark place and avoiding temperatures above 40C (104F) as excessive heat can reduce potency. The instruction also warns about the onset of oxidation which can be indicated by a brown color change.*
FDA Label Image

Uses (Uses)

Uses (Uses)
This text provides information on the various dental procedures where a product can be used for controlling bleeding or topical hemostasis. These procedures include implantation, root canals, gingivectomy, frenectomy, tissue retraction, oral surgery, and crown and bridge preparations.*
FDA Label Image

Do Not Use (Warning Do Not Use)

Do Not Use (Warning Do Not Use)
This text appears to be a warning label or cautionary statement about a product. It advises against using the product in individuals with certain medical conditions such as cardiovascular disease, diabetes, hyperthyroidism, hypertension, and arteriosclerosis or if they are being treated with tricyclic antidepressants. Additionally, it mentions that inhalation of anesthetics containing halogen or cyclopentane can intensify any potential systemic reactions.*
FDA Label Image

Warnings (Warning Topical Use Only)

Warnings (Warning Topical Use Only)
This text is a warning that indicates the product is meant for use on the skin surface only and not for internal consumption or other uses.*

* These product label images have been analyzed using experimental machine learning. Please verify findings with the primary label text.