ALCOHOL-FREE ANTICAVITY- sodium fluoride liquid

Alcohol-Free Anticavity by

Drug Labeling and Warnings

Alcohol-Free Anticavity by is a Otc medication manufactured, distributed, or labeled by CVS Pharmacy, Inc, Vi-Jon, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Sodium fluoride 0.0219% (0.01% w/v fluoride ion)

Purpose

Anticavity

Use

aids in the prevention of dental cavities

WARNINGS

Warnings

Keep out of reach of children.

If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

Adults and children 6 years of age and older:

• use twice daily after brushing your teeth with a toothpaste
• vigorously swish 10 mL (2 teaspoonfuls) of rinse between your teeth for 1 minute then spit out
• do not swallow the rinse
• do not eat or drink for 30 minutes after rinsing
• instruct children under 12 years of age in good rinsing habits (to minimize swallowing)
• supervise children as necessary until capable of using without supervision
• children under 6 years of age: consult a dentist or doctor

Inactive ingredients

water, glycerin, flavor, cetylpyridinium chloride, phosphoric acid, methylparaben, sodium saccharin, poloxamer 407, propylparaben, propylene glycol, disodium phosphate, red 33, green 3

SPL UNCLASSIFIED SECTION

Sealed with printed neckband for your protection.

Some rinses may cause surface staining to teeth. This is not permanent or harmful, and may be prevented by adequate brushing or removed at your next dental visit.

*This product is not manufactured or distributed by Procter & Gamble, distributor of Crest Pro-Health Advanced Anticavity Fluoride Rinse

CVS/pharmacy
ALCOHOL FREE FLUORIDE MOUTHWASH
Promotes fresh breath while fighting cavities
Alcohol-free formula will not burn as it helps kill germs

Distributed by: CVS/pharmacy Inc

One CVS Drive, Woonsocket, RI 02895

www.cvs.com 1-800-shop-CVS

Principal display panel

CVS pharmacy

Compare to the active ingredient in Crest Pro-Health Complete Anticavity Fluoride Rinse*

NEW!

Alcohol Free

FLUORIDE MOUTHWASH ANTICAVITY RINSE SODIUM FLUORIDE

5 BENEFITS:

• Helps prevent cavities
• Helps kill germs that cause bad breath
• Helps strengten enamel
• Helps clean the entire mouth
• No alcohol burn

Vivid Mint

1 L (33.8 FL OZ)

IMPORTANT: read directions for proper use

482.000/482AA

INGREDIENTS AND APPEARANCE

ALCOHOL-FREE ANTICAVITY 
sodium fluoride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59779-482
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.1 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)
PHOSPHORIC ACID (UNII: E4GA8884NN)
METHYLPARABEN (UNII: A2I8C7HI9T)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
POLOXAMER 407 (UNII: TUF2IVW3M2)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59779-482-86	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/03/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	02/03/2012

Labeler - CVS Pharmacy, Inc (062312574)

Registrant - Vi-Jon (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi-Jon		790752542	manufacture(59779-482)