CAVITY PROTECTION FRESH MINT ANTICAVITY MOUTHWASH- sodium fluoride mouthwash 
Oxyfresh Worldwide Inc

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Cavity Protection Fresh Mint Anticavity Mouthwash

Drug Facts

Active ingredient

Sodium fluoride 0.05%

Purpose

Anticavity rinse

Uses

Helps protect against cavities.

Warnings

For rinsing 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 more than one ounce is accidentally swallowed, contact a physician or Poison Control Center right away.

Do not use

if safety seal is torn or missing.

Directions

Shake well before using. Vigorously swish 1-2 capfuls for a minimum of 1 full minute. Refrain from rinsing, eating or drinking for 5 minutes.

Other information

Store away from direct sunlight.

INGREDIENTs

Water (Aqua), Xylitol, Sodium Benzoate, Potassium Phosphate, Flavor*, Stabilized Chlorine Dioxide (Oxygene), Sodium Hydroxide, Citric Acid.

*Contains Peppermint Essential Oil

Package Labeling:473ml

Outer Package2

Package Labeling:3.8 L

Label

CAVITY PROTECTION FRESH MINT ANTICAVITY MOUTHWASH 
sodium fluoride mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63615-001
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CHLORINE DIOXIDE (UNII: 8061YMS4RM)  
WATER (UNII: 059QF0KO0R)  
XYLITOL (UNII: VCQ006KQ1E)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
POTASSIUM PHOSPHATE, UNSPECIFIED FORM (UNII: B7862WZ632)  
OXYGEN (UNII: S88TT14065)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63615-001-01473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/23/2014
2NDC:63615-001-023800 mL in 1 JUG; Type 0: Not a Combination Product05/23/2014
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: 088872f1-196c-a108-e063-6394a90adbfb
Set id: 3efc66b2-fcf9-4d26-9cdd-1af8225312b4
Version: 3
Effective Time: 20231025
 
Oxyfresh Worldwide Inc