ANTICAVITY- sodium fluoride rinse
Publix Super Markets, 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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Publix 213.002-213AE rev 2

Active ingredient

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

Purpose

Anticavity rinse

Use

aids in the prevention of dental cavities

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

Sealed with printed neckband for your protection

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

DISTRIBUTED BY DOLGENCORP, LLC

100 MISSION RIDGE, GOODLETTSVILLE, TN 37072

principal display panel

DG health Anticavity Fluoride Rinse
Compare to Act Anticavity Fluoride Rinse
Mint Flavor
•Alcohol Free
•Strong cavity protection
IMPORTANT: Read directions for proper use
532 mL (18 FL OZ)

image description

ANTICAVITY
sodium fluoride rinse

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:56062-213
Route of Administration	ORAL

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:56062-213-44	.532 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/19/2007	05/28/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part355	08/19/2007	05/28/2020

Labeler - Publix Super Markets, Inc (006922009)

Registrant - Vi-Jon Inc (790752542)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, Inc		790752542	manufacture(56062-213)

Revised: 5/2020

Document Id: f913f3c7-2075-4e9b-843a-68f65ec3bc9d

Set id: e4657faa-3caa-4956-bba6-09f4538ffa4f

Version: 7

Effective Time: 20200528

Publix Super Markets, Inc