CINNA FRESH ANTICAVITY- sodium fluoride gel

CINNA FRESH ANTICAVITY by

Drug Labeling and Warnings

CINNA FRESH ANTICAVITY by is a Otc medication manufactured, distributed, or labeled by Bob Barker Company, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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:

INGREDIENTS AND APPEARANCE

CINNA FRESH ANTICAVITY 
sodium fluoride gel

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

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

Inactive Ingredients
Ingredient Name	Strength
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)

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

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

Labeler - Bob Barker Company, Inc. (058525536)