ANTICAVITY- sodium fluoride rinse
Old East Main Co

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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Dollar General 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

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 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 temperature

inactive ingredients

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

100 MISSION RIDGE, GOODLETTSVILLE, TN 37072

100% Satisfaction Guaranteed! (888) 309-9030

principal display panel

DG| health

Compare to the active ingredient of ACT Anticavity Fluoride Mouthwash

ANTICAVITY

FLUORIDE MOUTHWASH

ALCOHOL FREE

Strong Cavity Protection
Helps Strengthen Teeth
Freshnes Breath

MINT

IMPORTANT: READ DIRECTIONS FOR PROPER USE

18 FL OZ (532 mL)

image description

ANTICAVITY
sodium fluoride rinse

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:55910-213
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Sodium fluoride (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.2 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
MENTHOL (UNII: L7T10EIP3A)
METHYL SALICYLATE (UNII: LAV5U5022Y)
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
POLOXAMER 407 (UNII: TUF2IVW3M2)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM PHOSPHATE (UNII: SE337SVY37)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
EDETATE CALCIUM DISODIUM (UNII: 25IH6R4SGF)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
SODIUM BENZOATE (UNII: OJ245FE5EU)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
BENZYL ALCOHOL (UNII: LKG8494WBH)
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:55910-213-44	532 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/19/2007	02/10/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part355	08/19/2007	02/10/2022

Labeler - Old East Main Co (068331990)

Registrant - Vi-Jon, LLC (790752542)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		790752542	manufacture(55910-213)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		088520668	manufacture(55910-213)

Revised: 2/2022

Document Id: c5faa57a-b52d-4d94-b8af-3280699a3265

Set id: 5fa67a02-4577-452f-b0c8-c4ebb005f0a5

Version: 13

Effective Time: 20220210

Old East Main Co