CAVITY PROTECTION FRESH MINT- sodium fluoride paste, dentifrice

Cavity Protection Fresh Mint by

Drug Labeling and Warnings

Cavity Protection Fresh Mint by is a Otc medication manufactured, distributed, or labeled by Oxyfresh Worldwide Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Sodium fluoride 0.235%

Purpose

Anticavity paste

Uses

Helps protect against cavities.

Warnings

For topical application only. Do not swallow.

Keep out of reach of children

under six years of age.  

• Not to be used by children under six, unless recommended by a dentist or physician.
• If paste is accidentally swallowed, contact a physician or Poison Control Center right away.

Do not use

if safety seal is torn or missing.

Directions

Apply a pearl-size drop onto a toothbrush. Gently brush teeth in a circular motion for 2-3 minutes after each meal.

Other information

Store away from direct sunlight.

INGREDIENTs

Sorbitol, Hydrated Silica, Glycerin, Water (Aqua), Sodium Lauryl Sulfate, Chondrus Crispus (Carrageenan), Stabilized Chlorine Dioxide (Oxygene), Sucralose, Zinc Acetate, Titanium Dioxide, Flavor*. Peppermint oil

Package Labeling:

INGREDIENTS AND APPEARANCE

CAVITY PROTECTION FRESH MINT 
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63615-000
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	2.35 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
SORBITOL (UNII: 506T60A25R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
CHONDRUS CRISPUS (UNII: OQS23HUA1X)
OXYGEN (UNII: S88TT14065)
SUCRALOSE (UNII: 96K6UQ3ZD4)
ZINC ACETATE (UNII: FM5526K07A)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
PEPPERMINT OIL (UNII: AV092KU4JH)
CHLORINE DIOXIDE (UNII: 8061YMS4RM)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63615-000-01	1 in 1 CARTON	05/23/2014
1		142 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M021	05/23/2014

Labeler - Oxyfresh Worldwide Inc (103385522)