CAVITY PROTECTION FRESH MINT- sodium fluoride paste, dentifrice 
Oxyfresh Worldwide Inc

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Cavity Protection Fresh Mint Toothpaste

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:

Outer PackageInner Package

CAVITY PROTECTION FRESH MINT 
sodium fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63615-000
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION2.35 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63615-000-011 in 1 CARTON05/23/2014
1142 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02105/23/2014
Labeler - Oxyfresh Worldwide Inc (103385522)

Revised: 10/2023
Document Id: 0888b5f3-0425-f641-e063-6394a90a89c2
Set id: 0ae98f28-7e78-4379-93b0-4f2657415c4d
Version: 2
Effective Time: 20231025
 
Oxyfresh Worldwide Inc