ANTICAVITY- sodium fluoride rinse

Anticavity by

Drug Labeling and Warnings

Anticavity by is a Otc medication manufactured, distributed, or labeled by Vi Jon, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

TEP

SEALED WITH PRONTED NECKBAND FOR YOUT PROTECTION

Active ingredient

Sodium fluoride 0.05%(0.02%w/v fluoride ion)

Purpose

Anticavity rinse

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, seek professional assistance or contact a Poison Control Center Immediately.

Directions

• adults and children 6 years of age and older: use once a day after brushing your teeth with a toothpaste
• remove cap
• pour 10 milliliters (10 mL  mark on inside of cap); do not fill above 10 mL mark
• vigorously swish 10 milliliters of rinse betweejn your teeth for 1 minure 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 minimizw swallowing)
• supervise childrenas necessary until capable of using without supervision
• children under 6 years of age: consult a dentist or doctor

other information

• store at room temperature

Inactive ingredients

benzyl alcohol, calcium disodium EDTA, cetylpyridinium chloride, disodium EDTA, disodium phosphate, flavor, green 3, menthol, methyl salicylate, poloxamer 407, polysorbate 20, potassium sorbate, propylene glycol, sodium benzoate, sodium phosphate, sodium saccharin, sorbitol, water, yellow 5

ADA Council statement

The ADA Council on Scientific Affair Acceptance os Swan Anticavity Fluoride Rinse is based on its finding that the product is effective in helping to prevent and reduce tooth decay, when used as directed.

This product is not manufactured or distributed by Chattem, Inc., distributor of Act Anticavity Fluoride Rinse

disclaimer

Manufactured by: Vi-Jon, Inc, St. Louis, MO 63114

Questions or Comments?  1-888-593-0593

Made in the USA

with US and foreign parts.

213.002/213AE rev 2

Principal Display Panel

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

ANTICAVITY

ALCOHOL FREE

FLUORIDE RINSE

mint

flavor

Strong cavity

Protection

Compare to acrive ingredient of Act Anticavity Fluoride Rinse

IMPORTANT: REAED DIRECTIONS FOR PROPER USE m1.jpg

18 FL OZ (532 mL)

ADA Accepted

American 

Dental

Association 

Principal Display Panel

mountain

falls

Compare

to Act

alcohol

free

helps 

strengthen

teeth

strong

cavity

protection

freshens

breath

anticavity

fluoride

rinse

mint

IMPORTANT:

READ DIRECTIONS

FOR PROPER USE

532 mL (18 FL OZ)

INGREDIENTS AND APPEARANCE

ANTICAVITY 
sodium fluoride rinse

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0869-0213
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.2094 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
BENZYL ALCOHOL (UNII: LKG8494WBH)
EDETATE CALCIUM DISODIUM ANHYDROUS (UNII: 8U5D034955)
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)
EDETATE CALCIUM DISODIUM (UNII: 25IH6R4SGF)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)
MENTHOL (UNII: L7T10EIP3A)
METHYL SALICYLATE (UNII: LAV5U5022Y)
POLOXAMER 407 (UNII: TUF2IVW3M2)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM PHOSPHATE (UNII: SE337SVY37)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SORBITOL (UNII: 506T60A25R)
water (UNII: 059QF0KO0R)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0869-0213-44	532 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/21/2001

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	06/21/2001

Labeler - Vi Jon (790752542)

Registrant - Vi Jon (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi Jon		790752542	manufacture(0869-0213)