ALCOHOL-FREE ANTICAVITY- sodium fluoride liquid
CVS Pharmacy, Inc

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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CVS 482.001/482AB Anticavity Fluoride Mouthwash

Active ingredient

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

Purpose

Anticavity

Use

aids in the prevention of dental cavities

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, cetylpyridinium chloride, flavor, sodium saccharin, phosphoric acid, sodium benzoate, sucralose, poloxamer 407, benzoic acid, disodium phosphate, propylene glycol, red 33, green 3

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

image description

ALCOHOL-FREE ANTICAVITY
sodium fluoride liquid

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

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

Ingredient Name	Strength
Inactive Ingredients
water (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
PHOSPHORIC ACID (UNII: E4GA8884NN)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SUCRALOSE (UNII: 96K6UQ3ZD4)
POLOXAMER 407 (UNII: TUF2IVW3M2)
BENZOIC ACID (UNII: 8SKN0B0MIM)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:59779-482-86	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/03/2012	04/16/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part355	02/03/2012	04/16/2016

Labeler - CVS Pharmacy, Inc (062312574)

Registrant - Vi-Jon, LLC (790752542)

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

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		088520668	manufacture(59779-482)

Revised: 9/2023

Document Id: ad51b772-289c-4974-906f-69817c454a51

Set id: 1b19ec3c-37ff-4c55-bc3e-ef2bb5c48416

Version: 12

Effective Time: 20230927

CVS Pharmacy, Inc