TRIAMCINOLONE ACETONIDE (Page 2 of 2)

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

Triamcinolone Acetonide Dental Paste USP, 0.1% is supplied as light beige odorless paste with fine gritty texture, having no lumps filled in aluminum or laminated tubes containing 5 g of dental paste in laminated tubes (NDC 70752-140-16) and 5 g of dental paste in aluminum tubes (NDC 70752-140-17).

Storage

Keep tightly closed. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Manufactured by:
Quagen Pharmaceuticals LLC
West Caldwell, NJ 07006

52021
Rev. 12/22

PRINCIPAL DISPLAY PANEL for 5 g Laminate Tube Label

NDC 70752-140 -16
Triamcinolone Acetonide Dental Paste USP, 0.1%
5g Rx only

laminatedtubbelabel
(click image for full-size original)

PRINCIPAL DISPLAY PANEL for 5 g Laminate Tube Carton Label
NDC 70752-140 -16
Triamcinolone Acetonide Dental Paste USP, 0.1%
5 g Rx only

laminatecartonlabel
(click image for full-size original)

PRINCIPAL DISPLAY PANEL for 5 g Aluminum Tube Carton Label

NDC 70752-140 -17
Triamcinolone Acetonide Dental Paste USP, 0.1%
5 g Rx only

alucartonlabel
(click image for full-size original)

TRIAMCINOLONE ACETONIDE
triamcinolone acetonide paste
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70752-140
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 Multilevel Packaging
1 NDC:70752-140-16 1 TUBE in 1 CARTON contains a TUBE
1 5 g in 1 TUBE This package is contained within the CARTON (70752-140-16)
2 NDC:70752-140-17 1 TUBE in 1 CARTON contains a TUBE
2 5 g in 1 TUBE This package is contained within the CARTON (70752-140-17)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA214582 01/15/2023
Labeler — QUAGEN PHARMACEUTICALS LLC (073645339)
Registrant — QUAGEN PHARMACEUTICALS LLC (073645339)
Establishment
Name Address ID/FEI Operations
QUAGEN PHARMACEUTICALS LLC 080281331 MANUFACTURE (70752-140), PACK (70752-140)

Revised: 02/2023 QUAGEN PHARMACEUTICALS LLC

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