DentaGel (Page 2 of 2)

Rising Pharmaceuticals, Inc. 29 October 2018

PRINCIPAL DISPLAY PANEL — 56 g Tube

Rising NDC 64980-307-60

Denta Gel 1.1%

1.1% SODIUM FLUORIDE PRESCRIPTION GEL
Brush-on Gel (non-abrasive formula)

Fresh Mint

NET WT. 2 OZ. (56 g) Rx only

(click image for full-size original)

DENTAGEL
sodium fluoride gel

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:64980-307
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (FLUORIDE ION)	SODIUM FLUORIDE	1.1 g in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER
SORBITOL
HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)
POLOXAMER 407
METHYLPARABEN
PROPYLPARABEN
FD&C BLUE NO. 1
SACCHARIN SODIUM

Product Characteristics
Color	BLUE	Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:64980-307-60	56 g in 1 TUBE	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED DRUG OTHER		05/01/2012

Labeler — Rising Pharmaceuticals, Inc. (041241766)

Registrant — Rising Pharmaceuticals, Inc. (041241766)

Establishment
Name	Address	ID/FEI	Operations
Sheffield Pharmaceuticals Div of Faria Limited LLC		151177797	MANUFACTURE (64980-307)

Revised: 10/2018 Rising Pharmaceuticals, Inc.

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DentaGel (Page 2 of 2)

PRINCIPAL DISPLAY PANEL — 56 g Tube

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