ANTICAVITY- sodium fluoride rinse

Anticavity by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active ingredient

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

Purpose

Anticavity rinse

Use

aids in the prevention of dental cavities

WARNINGS

Warning

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 for 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 milliliter 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

Other information

store at room temperatue

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

SPL UNCLASSIFIED SECTION

*This product is not manufactured or distributed by Chattem, Inc., distributor of Act Anticavity Fluoride Rinse
The ADA Council on Scientific affairs Acceptance of the Rite Aid Anticavity Fluoride Rinse is based on its findings the the product is effective in helping to prevent and reduce tooth decay, when used as directed

DISTRIBUTED BY:
Rite aid
30 Hunter Lane, Camp Hill, P 17011
Satisfaction Guaranteed

PRINCIPAL DISPLAY PANEL

Sealed With Printed Neckband for your protection
IMPORTANT READ DIRECTIONS FOR PR0POE USE
oral care
anticavity fluoride rinsemint
alcohol free
helps prevent cavities
strengthens teeth
freshens breath
ADA Accepted
American Dental Association
18 FL OZ (532 mL)

INGREDIENTS AND APPEARANCE

ANTICAVITY 
sodium fluoride rinse

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11822-0213
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Sodium fluoride (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	Sodium fluoride	0.05 kg  in 100 L

Inactive Ingredients
Ingredient Name	Strength
BENZYL ALCOHOL (UNII: LKG8494WBH)
EDETATE CALCIUM DISODIUM ANHYDROUS (UNII: 8U5D034955)
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
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: 11822-0213-4	.532 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/25/2005

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	02/25/2005

Labeler - Rite Aid (014578892)

Registrant - Vi-Jon Inc (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi-Jon, Inc		790752542	manufacture(11822-0213)