Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Oralone ® (Triamcinolone Acetonide Dental Paste USP, 0.1%) is supplied in tubes containing 5 g of dental paste (NDC 51672–1335-5) and 7.5 g of dental paste (NDC 51672–1335-8). Storage Keep tightly closed. Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].; PRINCIPAL DISPLAY PANEL - 7.5 g Carton 0.1% DENTAL PASTE Oralone ® Triamcinolone Acetonide Dental Paste USP, 0.1% FOR TOPICAL USE IN ADJUNCTIVE TREATMENT OF ORAL LESIONS Keep this and all medications out of the reach of children. NET WT 7.5 g NDC 51672-1335-8 Rx only TaroPharma ® PRINCIPAL DISPLAY PANEL - 7.5 g Carton
- HOW SUPPLIED Oralone ® (Triamcinolone Acetonide Dental Paste USP, 0.1%) is supplied in tubes containing 5 g of dental paste (NDC 51672–1335-5) and 7.5 g of dental paste (NDC 51672–1335-8). Storage Keep tightly closed. Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].
- PRINCIPAL DISPLAY PANEL - 7.5 g Carton 0.1% DENTAL PASTE Oralone ® Triamcinolone Acetonide Dental Paste USP, 0.1% FOR TOPICAL USE IN ADJUNCTIVE TREATMENT OF ORAL LESIONS Keep this and all medications out of the reach of children. NET WT 7.5 g NDC 51672-1335-8 Rx only TaroPharma ® PRINCIPAL DISPLAY PANEL - 7.5 g Carton
Overview
Oralone ® (Triamcinolone Acetonide Dental Paste USP, 0.1%), contains the corticosteroid triamcinolone acetonide in an adhesive vehicle suitable for application to oral tissues. Triamcinolone acetonide is designated chemically as 9-fluoro-11β, 16α, 17, 21-tetrahydroxypregna-1, 4-diene-3, 20-dione cyclic 16, 17-acetal with acetone. The structural formula of triamcinolone acetonide is as follows: Each gram of Oralone ® contains 1 mg triamcinolone acetonide in an emollient dental paste containing gelatin, pectin, and carboxymethylcellulose sodium in a plasticized hydrocarbon gel (a polyethylene and mineral oil gel base). Chemical Structure
Indications & Usage
Oralone ® (Triamcinolone Acetonide Dental Paste USP, 0.1%) is indicated for adjunctive treatment and for the temporary relief of symptoms associated with oral inflammatory lesions and ulcerative lesions resulting from trauma.
Dosage & Administration
Press a small dab (about 1/4 inch) to the lesion until a thin film develops. A larger quantity may be required for coverage of some lesions. For optimal results use only enough to coat the lesion with a thin film. Do not rub in. Attempting to spread this preparation may result in granular, gritty sensation and cause it to crumble. After application, however, a smooth, slippery film develops. The preparation should be applied at bedtime to permit steroid contact with the lesion throughout the night. Depending on the severity of symptoms, it may be necessary to apply the preparation two or three times a day, preferably after meals. If significant repair or regeneration has not occurred in seven days, further investigation is advisable.
Warnings & Precautions
No warnings available yet.
Contraindications
Oralone ® is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation; it is also contraindicated in the presence of fungal, viral, or bacterial infections of the mouth or throat.
Adverse Reactions
The following local adverse reactions may occur with corticosteroid-containing dental pastes: burning, itching, irritation, dryness, blistering or peeling not present prior to therapy, perioral dermatitis, allergic contact dermatitis, maceration of the oral mucosa, secondary infection, and atrophy of the oral mucosa. Also, see PRECAUTIONS for potential effects of systemic absorption.
Storage & Handling
Storage Keep tightly closed. Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].
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