CINNA FRESH ANTICAVITY- sodium fluoride gel
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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CINNA FRESH ANTICAVITY GEL TOOTHPASTE

Drug Facts

Active ingredient:

Sodium Fluoride - 0.22% (0.1% w/ 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, Color FD&C 40Water, Sorbitol, Sodium Lauryl Sulfate, Carbomer, Sodium Saccharin, Sodium Hydroxide, PEG-40 Hydrogenated Castor Oil, Flavor, Sodium Benzoate

Package Labeling:

Label3

CINNA FRESH ANTICAVITY
sodium fluoride gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:53247-201
Route of Administration	DENTAL

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

Ingredient Name	Strength
Inactive Ingredients
FD&C RED NO. 40 (UNII: WZB9127XOA)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SODIUM BENZOATE (UNII: OJ245FE5EU)
METHYL SALICYLATE (UNII: LAV5U5022Y)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:53247-201-24	24 g in 1 TUBE; Type 0: Not a Combination Product	01/29/2020	12/31/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part355	01/29/2020	12/31/2021

Labeler - Bob Barker Company, Inc. (058525536)

Revised: 12/2021

Document Id: d50e49b6-de94-47e5-bc96-96493783e32c

Set id: d019c4f0-8c0a-42a0-a14d-1f5c550ab237

Version: 3

Effective Time: 20211222

Bob Barker Company, Inc.