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CinnaFresh Anti-cavity

Dosage form: gel, dentifrice
Ingredients: Sodium Fluoride 0.1g in 100g
Labeler: Bob Barker Company Inc.
NDC Code: 53247-103

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.

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)

CINNAFRESH   ANTI-CAVITY
sodium fluoride gel, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53247-103
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sodium Fluoride (Fluoride Ion) Fluoride Ion0.1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
Sorbitol 
Water 
Sodium Lauryl Sulfate 
Carboxymethylcellulose 
Saccharin Sodium 
Sodium Benzoate 
FD&C Red No. 40 
Packaging
#Item CodePackage Description
1NDC:53247-103-6124 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35501/15/2015
Labeler - Bob Barker Company Inc. (058525536)
Establishment
NameAddressID/FEIOperations
Vikshara Trading & Investments Ltd675920690MANUFACTURE(53247-103)

Revised: 04/2016
 
Bob Barker Company Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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