SODIUM FLUORIDE mouthwash

Sodium fluoride by

Drug Labeling and Warnings

Sodium fluoride by is a Otc medication manufactured, distributed, or labeled by Demoulas Super Markets, Inc, Consumer Product Partners, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Claims

Leaves your entire mouth feeling clean while it helps strengthen teeth and prevent tooth decay.

Active ingredient

Sodium fluoride 0.02% (0.009% w/v fluoride ion)

Purpose

Anticavity

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, get medical help or contact a Poison Control Center right away.

Directions

Adults and children 6 years of age and older:

• use twice a day after brushing your teeth with a toothpaste
• vigorously swish 10 mL (2 teaspoonfuls) 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

Inactive ingredients

water, alcohol (11%), sorbitol, poloxamer 407, propylene glycol, sodium benzoate, flavor, sodium phosphate, polysorbate 20, sodium saccharin, cetylpyridinium chloride, disodium phosphate, calcium disodium EDTA, blue 1

Adverse reaction

*This  product is not manufactured or distributed by Chattem Inc., distributor of Act Restoring Anticavity Mouthwash Cool Mint

Like it or let us make it right.

DSP-TN-21091

DSP-MO-20087

DISTRIBUTED BY 

DEMOULAS SUPER MARKETS, INC.

875 EAST STREET

TEWKSBURY, MA 01876

Principal Panel Display

Sealed With Printed Neckband For Your Proection

MARKET BASKET

"MORE FOR YOUR DOLLAR"

compare to Act Restoring Anticavity Fluoride Mouthwash*

Restoring Anticavity Fluoride Mouthwash

ANTICAVITY MOUTHWASH

Restores enamel

Helps avoid tooth decay

Helps remineralize soft spots

Freshens breath

IMPORTANT: read directions for proper use.

33.8 FL OZ (1 L)

INGREDIENTS AND APPEARANCE

SODIUM FLUORIDE 
sodium fluoride mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53942-581
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
SORBITOL (UNII: 506T60A25R)
POLOXAMER 407 (UNII: TUF2IVW3M2)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM PHOSPHATE (UNII: SE337SVY37)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
EDETATE CALCIUM DISODIUM ANHYDROUS (UNII: 8U5D034955)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53942-581-86	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/05/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M021	06/05/2023

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(53942-581)