CinnaFresh Anti-cavity

CinnaFresh by

Drug Labeling and Warnings

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

Drug Details [pdf]

CINNAFRESH  ANTI-CAVITY- 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

Anti-cavity

Drug Facts

Active Ingredient

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

Purpose

Anticavity toothpaste

Use

Aids in the prevention of dental 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

Do not swallow

  • Supervise children as necessary until capable of using without supervision
  • Instruct children under 12 years of age in good brushing and rinsing habits (to minimize swallowing).
  • Adults and children 6 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or a doctor.
  • Children under 2 years of age: Consult a dentist or doctor.

Inactive Ingredients

Sorbitol, Purified Water, Precipitated Silica, Sodium Lauryl Sulphate, Carboxymethyl Cellulose, Flavor, Polyethylene Glycol 32, Sodium Saccharin, Sodium Benzoate, FD&C Red # 40.

PRINCIPAL DISPLAY PANEL - 24 g Tube Label

CinnaFresh
anticavity gel toothpaste

NET WT. 0.85 OZ
(24 GRAMS)

Principal Display Panel - 24 g Tube Label
CINNAFRESH   ANTI-CAVITY
sodium fluoride gel, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 53247-103
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
SORBITOL (UNII: 506T60A25R)  
WATER (UNII: 059QF0KO0R)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 53247-103-6124 g in 1 TUBE; Type 0: Not a Combination Product01/15/201512/01/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35501/15/201512/01/2019
Labeler - Bob Barker Company Inc. (058525536)

Revised: 2/2020
Document Id: 9eede88f-d2ec-49e2-e053-2995a90a195b
Set id: 1d197c49-e21f-4107-9a27-02a89b78e9a3
Version: 4
Effective Time: 20200219
 
Bob Barker Company Inc.