Triamcinolone Paste
Name: Triamcinolone Paste
Triamcinolone Paste Description
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 triamcinolone acetonide dental paste 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).
Contraindications
Triamcinolone acetonide dental paste 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.
How is Triamcinolone Paste Supplied
Triamcinolone Acetonide Dental Paste, USP 0.1% is supplied in tubes containing 5 g of dental paste (NDC 0713-0655-40).
Storage
Keep tightly closed. Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].
Manufactured by:
G&W Laboratories, Inc.
111 Coolidge Street
South Plainfield, NJ 07080
Issued: 06/2016
8-0655GW1
Principal display panel
TRIAMCINOLONE ACETONIDE
triamcinolone acetonide paste |
| Product Information | | Product Type | HUMAN PRESCRIPTION DRUG LABEL | Item Code (Source) | NDC:0713-0655 | | Route of Administration | DENTAL | DEA Schedule | | |
| Active Ingredient/Active Moiety | | Ingredient Name | Basis of Strength | Strength | | Triamcinolone Acetonide (Triamcinolone Acetonide) | Triamcinolone Acetonide | 1 mg in 1 g | |
| Inactive Ingredients | | Ingredient Name | Strength | | Gelatin | | | Pectin | | | Carboxymethylcellulose Sodium | | | High Density Polyethylene | | | Mineral Oil | | |
| Product Characteristics | | Color | BROWN (light beige) | Score | | | Shape | | Size | | | Flavor | | Imprint Code | | | Contains | | |
| Packaging | | # | Item Code | Package Description | | 1 | NDC:0713-0655-40 | 1 TUBE in 1 CARTON | | 1 | | 5 g in 1 TUBE | |
|
| Marketing Information | | Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date | | ANDA | ANDA205592 | 01/13/2017 | | |
| Labeler - G&W Laboratories, Inc. (001271188) |
| Registrant - G&W Laboratories, Inc. (001271188) |
| Establishment |
| Name | Address | ID/FEI | Operations |
| G&W Laboratories, Inc. | | 001271188 | MANUFACTURE(0713-0655) |
Revised: 01/2017 G&W Laboratories, Inc.
