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 American Sales Company, Vi-Jon. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

TEP

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

Active ingredients

Sodium fluoride 0.02% (0.0 1% w/v fluoride ion)

Purpose

Anticavity

Use

aids in the prevention of dental cavities

Warning

for this product

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 and 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

Claims

This rinse may cause temporary staining to the surface of teeth. This is not harmful, and adequate brushing may prevent its occurence.

Dislcaimer

Ths product is not manufactured or distributed by Procter & Gamble, distributor of Crest Pro-Health Complete Anticavity Fluoride Rinse.

482.001/482AB

Adverse reaction

DISTRIBUTED BY:

FODHOLD U.S.A., LLC

LANDOVER, MD 20785

1-877-846-9949

PRINCIPAL DISPLAY PANEL

Compare to the Active Ingredient in Crest Pro-Health Advanced Anticavity Fluoride Mouthwash

CAREONE

ALCOHOL FREE FLUORIDE

MOUTH

WASH

ANTICAVITY FLUORIDE RINSE

VIOLET MINT FLAVOR

Kils Bad Breath Germs

Helps Prevent Cavities

Helps Strengthen Enamel

Cleans Teeth

Freshens Breath

1 LITER

(3.8 FL OZ)

IMPORTANT: Read directions for proper use

INGREDIENTS AND APPEARANCE

ALCOHOL-FREE ANTICAVITY 
sodium fluoride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41520-482
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)
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41520-482-86	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/03/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	02/01/2013

Labeler - American Sales Company (809183973)

Registrant - Vi-Jon (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi-Jon		790752542	manufacture(41520-482)