ANTICAVITY FLUORIDE RINSE- sodium fluoride mouthwash

Anticavity Fluoride Rinse by

Drug Labeling and Warnings

Anticavity Fluoride Rinse by is a Otc medication manufactured, distributed, or labeled by DEMOULAS SUPER MARKETS, INC, Vi-Jon, LLC. 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

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.

Directiions

• 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

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

DISTRIBUTED BY: Demoulas Super Markets, Inc., 875 East Street, Tewksbury, MA 01876

principal display panel

Sealed With Printed Necband For Your Protection

"MORE FOR YOUR DOLLAR"

Market Basket

COMPARE TO ACT*

Mint Flavor

ANTI-CAVITY Fluoride Rinse

• Alcohol free
• Strong cavity protection
• Strengthens teeth
• Freshens breath

IMPORTANT: read directions for proper use.

18 FL OZ (532 mL)

INGREDIENTS AND APPEARANCE

ANTICAVITY FLUORIDE RINSE 
sodium fluoride mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53942-213
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
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 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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53942-213-44	532 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/25/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M021	08/25/2021

Labeler - DEMOULAS SUPER MARKETS, INC (007869647)

Registrant - Consumer Product Partners, LLC (119091520)

Establishment
Name	Address	ID/FEI	Business Operations
Consumer Product Partners, LLC		119091514	manufacture(53942-213)