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CinnaFresh Anti-cavity

Medically reviewed on Jan 12, 2018

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
SKYLARK CMC PVT. LTD.650174824MANUFACTURE(53247-103)

 
Bob Barker Company Inc.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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