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TRIAMCINOLONE ACETONIDE DENTAL PASTE 0.1% 5 G - 1 mg/g PASTE
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TRIAMCINOLONE ACETONIDE DENTAL PASTE 0.1% 5 G

Generic: Triamcinolone Acetonide

TRIAMCINOLONE ACETONIDE DENTAL PASTE 0.1% 5 G

NDC:51672-1267-05
Manufacturer:Sun Pharmaceutical Industries, Inc.
Strength:1 mg/g
Dosage Form:PASTE
Route:DENTAL

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Drug Information

Identification

Generic Name

Triamcinolone Acetonide

Brand Name

Triamcinolone Acetonide

Labeler / Distributor

Sun Pharmaceutical Industries, Inc.

Product Type

HUMAN PRESCRIPTION DRUG

Administration

Dosage Form

PASTE

Route of Administration

DENTAL

FDA Application Number

ANDA070730

Active Ingredients

IngredientStrength
TRIAMCINOLONE ACETONIDE1 mg/g

Pharmacological Class

Corticosteroid Hormone Receptor Agonists [MoA]Corticosteroid

Data sourced from openFDA / DailyMed. For full prescribing information, consult the drug label.

Clinical Drug Information

Indications & Usage

INDICATIONS AND USAGE 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

DOSAGE AND 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.

Adverse Reactions

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. To report SUSPECTED ADVERSE REACTINS, contact Sun Pharmaceutical Industries, Inc., at 1-866-923-4914 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Information for Patients

Information for the Patient Patients using topical corticosteroids should receive the following information and instructions: This medication is to be used as directed by the physician or dentist. It is for oral use only; it is not intended for ophthalmic or dermatological use. Patients should be advised not to use this medication for any disorder other than for which it was prescribed. Patients should report any signs of adverse reactions. As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, contact the physician or dentist.

Clinical data sourced from openFDA drug labeling. For complete prescribing information, consult the full drug label.