ANTICAVITY FLUORIDE RINSE- sodium fluoride mouthwash
Duane Reade

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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Duane Reade 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 after brushing your teeth with a toothpaste

remove cap
pour 10 milliliters (10 mL mark on the inside of cap); do not fill above the 10 mL mark
vigorously swish 10 milliliters of rinse between your teeth for 1 minute 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

TEP

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

Adverse Reactions

Distributed by: Duane Reade

440 Ninth Avenue

NY, NY 10001

(866)375-6925/duanereade.com

213.002/213AE rev 2

Principal display panel

Uniquely NY DR since 1960

Anticavity

Fluoride Rinse

mint

strong cavity protection

alcohol free

IMPORTANT: READ DIRECTIONS FOR PROPER USE

18 FL OZ (532 mL)

image description

ANTICAVITY FLUORIDE RINSE
sodium fluoride mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:67732-213
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, UNSPECIFIED FORM (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 ANHYDROUS (UNII: 8U5D034955)
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:67732-213-44	532 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/03/2003	03/03/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part355	11/03/2003	03/03/2021

Labeler - Duane Reade (011988995)

Registrant - Vi-Jon, LLC (790752542)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		790752542	manufacture(67732-213)

Revised: 3/2021

Document Id: 7fa840af-31f5-47c1-8795-4efad1ec38d1

Set id: 5dab4852-6ec9-4fa3-8ec0-c054326352ec

Version: 9

Effective Time: 20210303

Duane Reade