KENALOG® IN ORABASE® Triamcinolone Acetonide Dental Paste USP

KENALOG - triamcinolone acetonide paste, dentifrice 
E.R. Squibb & Sons, L.L.C.

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DESCRIPTION

Each gram of Kenalog in Orabase provides 1 mg (0.1%) triamcinolone acetonide in emollient dental paste containing gelatin, pectin, and carboboxymethylcellulose sodium in Plastibase® (Plasticized Hydrocarbon Gel), a polyethylene and mineral oil gel base.

ACTIONS

Kenalog (Triamcinolone Acetonide) is a synthetic corticosteroid which possesses anti-inflammatory, antipruritic, and antiallergic action. The emollient dental paste acts as an adhesive vehicle for applying the active medication to the oral tissues. The vehicle provides a protective covering which may serve to temporarily reduce the pain associated with oral irritation.

INDICATIONS

Kenalog in Orabase is indicated for adjunctive treatment and for the temporary relief of symptoms associated with oral inflammatory lesions and ulcerative lesions resulting from trauma.

CONTRAINDICATIONS

This preparation is contraindicated in patients with a history of hypersensitivity to any of its components.

Because it contains a corticosteroid, the preparation is contraindicated in the presence of fungal, viral, or bacterial infections of the mouth or throat.

WARNING

Usage in Pregnancy

Safe use of this preparation during pregnancy has not been established with respect to possible adverse reactions upon fetal development; therefore, it should not be used in women of child-bearing potential and particularly during early pregnancy unless, in the judgement of the physician or dentist, the potential benefits outweigh the possible hazards.

PRECAUTIONS

Patients with tuberculosis, peptic ulcer or diabetes mellitus should not be treated with any corticosteroid preparation without the advice of the patient’s physician.

It should be borne in mind that the normal defensive responses of the oral tissues are depressed in patients receiving topical corticosteroid therapy. Virulent strains of oral microorganisms may multiply without producing the usual warning symptoms of oral infections.

The small amount of steroid released when the preparation is used as recommended makes systemic effects very unlikely; however, they are a possibility when topical corticosteroid preparations are used over a long period of time.

If local irritation or sensitization should develop, the preparation should be discontinued and appropriate therapy instituted.

If significant regeneration or repair of oral tissues has not occurred in seven days, additional investigation into the etiology of the oral lesion is advised.

ADVERSE REACTIONS

Prolonged administration may elicit the adverse reactions known to occur with systemic steroid preparations; for example, adrenal suppression, alteration of glucose metabolism, protein catabolism, peptic ulcer activations, and others. These are usually reversible and disappear when the hormone is discontinued.

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.

HOW SUPPLIED

Kenalog® in Orabase® (Triamcinolone Acetonide Dental Paste USP) is available in 5 g tubes (NDC 0003-0496-20).

APOTHECON®
A Bristol-Myers Squibb Company
Princeton, NJ 08540 USA

J2-482G
Revised May 1994

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REPRESENTATIVE PACKAGING

Not Applicable - No Longer Marketed

PDP Not Applicable

KENALOG 
triamcinolone acetonide paste, dentifrice
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0003-0496
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
triamcinolone acetonide (triamcinolone) triamcinolone acetonide1 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
gelatin 
pectin 
carboxymethylcellulose sodium 
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:0003-0496-205 g in 1 TUBENone

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01209701/01/200612/31/2006

Labeler - E.R. Squibb & Sons, L.L.C. (011550092)

Revised: 06/2006 E.R. Squibb & Sons, L.L.C.