CINNAFRESH- sodium fluoride gel, dentifrice

CinnaFresh by

Drug Labeling and Warnings

CinnaFresh by is a Otc medication manufactured, distributed, or labeled by Bob Barker Company Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts:

Active ingredient

Sodium Fluoride - 0.22% (0.1% w/v fluoride ion)

Purpose

Anticavity toothpaste

Use

Helps protect against cavities.

Warnings

Keep out of the reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center immediately.

Directions

• Adults & Children 6 years of age & older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor.
• Children 2 to 6 years: Use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing).
• Children under 2 years: Ask a dentist or physician.

Inactive ingredients

Sorbitol, Water, Hydrated Silica, Glycerin, Cellulose Gum, Sodium Lauryl Sulfate, Polyethylene Glycol, Sodium Benzoate, Flavor, Sodium Saccharin, FD&C 40

SPL UNCLASSIFIED SECTION

Dist. by Bob Barker Co. Inc. Fuquay-Varina, NC 27526

PRINCIPAL DISPLAY PANEL - 24 GRAM Tube Label

CinnaFresh®
anticavity gel toothpaste

Sodium Fluoride 0.22%

Bold Cinnamon Flavor

NET WT. 0.85 OZ
(24 GRAMS)

INGREDIENTS AND APPEARANCE

CINNAFRESH 
sodium fluoride gel, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53247-121
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Sodium Fluoride (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	Sodium Fluoride	2.2 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
SORBITOL (UNII: 506T60A25R)
Water (UNII: 059QF0KO0R)
Hydrated Silica (UNII: Y6O7T4G8P9)
Glycerin (UNII: PDC6A3C0OX)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
Sodium Lauryl Sulfate (UNII: 368GB5141J)
POLYETHYLENE GLYCOL 1600 (UNII: 1212Z7S33A)
Sodium Benzoate (UNII: OJ245FE5EU)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
FD&C RED NO. 40 (UNII: WZB9127XOA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53247-121-01	24 g in 1 TUBE; Type 0: Not a Combination Product	01/01/2008

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	01/01/2008

Labeler - Bob Barker Company Inc. (058525536)