Orostat 8% Solution
Product Images NDC 10129-006

11 FDA label images from Gingi-pak A Division Of The Belport · 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 text panel lists the active ingredient as 8% DL-Epinephrine Hydrochloride by weight in the product Orostat 8%, a dental solution used subgingivally.*
FDA Label Image

Description (Description)

Description (Description)
Text panel describing Orostat as a retraction agent and topical vasoconstrictor used to control capillary bleeding and oral tissue seepage, emphasizing its fast, positive action and clean, debris-free field.*
FDA Label Image

Directions (Directions)

Directions (Directions)
Text panel providing instructions for the use of Orostat 8% solution. It describes application methods using cotton pellets, sponge, or syringe tips, proper preparation and rinsing of the gingival area, and cautions against scrubbing or burnishing the gingival tissue. The instructions cover use in dental procedures involving retraction cords and impression taking.*
FDA Label Image

Inactive Ingredients (Inactive Ingredients)

Inactive Ingredients (Inactive Ingredients)
A drug facts text panel listing inactive ingredients of Orostat 8% solution, including purified water, sodium hydrosulfite, sodium thiosulfate, sodium monophosphate, sodium chloride, EDTA, methylparaben, propylparaben, and benzyl alcohol.*
FDA Label Image

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

Keep Out Of Reach If Children (Keep Out Of Children)
A drug facts or warning text panel containing the phrase "Keep out of reach of children." No other visible text or information is shown.*
FDA Label Image

Principal Display-orostat 8% (Orostat 15 Cc)

Principal Display-orostat 8% (Orostat 15 Cc)
Orostat 8% DL-Epinephrine-HCl Topical Hemostatic Solution label showing an 8% concentration in a 15cc package. The label includes multi-language names for DL Epinephrine HCl Solution, caution notice about federal law restricting sale or use to dentist's order, and manufacturer information for Gingi-Pak in Camarillo, CA. The label also advises avoiding heat above 40 °C (104 °F).*
FDA Label Image

Purpose (Purpose)

Purpose (Purpose)
A Drug Facts panel section titled 'Purpose' with the indication 'Hemostyptic' listed underneath, describing the intended use of the product.*
FDA Label Image

Storage (Storage)

Storage (Storage)
Storage instructions for Orostat 8% (Epinephrine Hydrochloride) solution advise keeping the product in a cool, dark place and avoiding heat above 40°C (104°F). A warning is included that a brown color change signals oxidation and reduced potency.*
FDA Label Image

Uses (Uses)

Uses (Uses)
Text panel excerpt describing the uses of Orostat 8% Epinephrine Hydrochloride solution for dental use. The text lists control of bleeding or topical hemostasis in routine dental procedures such as 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)
Text panel provides warnings about the use of Orostat 8% solution, highlighting contraindications for individuals with cardiovascular disease, diabetes, hyperthyroidism, hypertension, arteriosclerosis, or those treated with tricyclic antidepressants. It also notes that systemic reactions may be intensified by inhalation of anesthetics containing halogen or cyclopentane.*
FDA Label Image

Warnings (Warning Topical Use Only)

Warnings (Warning Topical Use Only)
A warning label panel from Orostat 8% solution stating that it is for topical applications only, emphasizing usage restrictions for this dental subgingival product containing epinephrine hydrochloride.*

* About these descriptions: Image descriptions on this page are generated by automated AI analysis of the product label images from the manufacturer's FDA label submission (SPL). They are provided for reference only and may contain errors or omissions. Always rely on the printed label itself and the official FDA labeling, and consult a pharmacist or healthcare professional with any questions about this product.