RESTORING ANTICAVITY- sodium fluoride liquid

Restoring Anticavity by

Drug Labeling and Warnings

Restoring Anticavity by is a Otc medication manufactured, distributed, or labeled by OLD EAST MAIN CO., Vi-Jon, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION\

ACTIVE INGREDIENT

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

Purpose

Anticavity

Use

aids in the prevention of dental cavities

warnings

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 reactions 

DISTRIBUTED BY OLD EAST MAIN CO

100 MISSION RIDGE

GOODLETTSVILLE, TN 37072

100% Satisfaction Guaranteed!

If you're not satisfied with this product for any reason,

please call us so we can make you 100% satisfied.

principal display panel

Since 1903

Rexall

Restoring

Anticavity

Fluoride Mouthwash

• Helps prevent cavities
• Helps strengthen enamel
• Freshens Breath
• Helps avoid tooth decay

IMPORTANT: read directions for proper use.

REFRESHING MINT

1 L (33.8 FL OZ)

INGREDIENTS AND APPEARANCE

RESTORING ANTICAVITY 
sodium fluoride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55910-581
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)
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)

Product Characteristics
Color		Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55910-581-86	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/15/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	03/15/2020

Labeler - OLD EAST MAIN CO. (068331990)

Registrant - Vi-Jon, Inc (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi-Jon, Inc		790752542	manufacture(55910-581)