CAVITY PROTECTION FRESH MINT ANTICAVITY MOUTHWASH- sodium fluoride mouthwash

Cavity Protection Fresh Mint Anticavity Mouthwash by

Drug Labeling and Warnings

Cavity Protection Fresh Mint Anticavity Mouthwash 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 0.05%

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

Package Labeling:3.8 L

INGREDIENTS AND APPEARANCE

CAVITY PROTECTION FRESH MINT ANTICAVITY MOUTHWASH 
sodium fluoride mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63615-001
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63615-001-01	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/23/2014
2	NDC: 63615-001-02	3800 mL in 1 JUG; Type 0: Not a Combination Product	05/23/2014

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)