CINNAFRESH- sodium fluoride gel, dentifrice 
Bob Barker Company Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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CinnaFresh®

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

Water, Sorbitol, Sodium Lauryl Sulfate, Carbomer, Sodium Saccharin, PEG – 40 Hydrogenated Castor Oil, Sodium Hydroxide, Sodium Benzoate, Flavor, FD&C 40

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)

PRINCIPAL DISPLAY PANEL - 24 GRAM Tube Label
CINNAFRESH 
sodium fluoride gel, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53247-120
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sodium Fluoride (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O) Sodium Fluoride2.2 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Sorbitol (UNII: 506T60A25R)  
Sodium Lauryl Sulfate (UNII: 368GB5141J)  
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
Sodium Hydroxide (UNII: 55X04QC32I)  
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
Sodium Benzoate (UNII: OJ245FE5EU)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53247-120-0124 g in 1 TUBE; Type 0: Not a Combination Product01/01/2008
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35501/01/2008
Labeler - Bob Barker Company Inc. (058525536)

Revised: 11/2019
Document Id: f4665894-6f7d-46c9-9e57-72d20e77e654
Set id: 3c199157-98a1-4a21-af86-60c3cce63f9b
Version: 1
Effective Time: 20191122
 
Bob Barker Company Inc.