ANTICAVITY RINSE- sodium fluoride mouthwash

Anticavity Rinse by

Drug Labeling and Warnings

Anticavity Rinse by is a Otc medication manufactured, distributed, or labeled by Family Dollar Services, Inc, Vi Jon, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Sodium Fluoride 0.05% (0.2% w/v fluoride ion)        

Purpose

Anticavity Rinse

Use

aids in the prevention of dental cavities

WARNINGS

Warnings

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 year of age and older: use once a day after 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 milliliters 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 year 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, poloxomer 407, polysorbate 80, propylene glycol, red 33, sodium benzoate, sodium phosphate, sodium saccharin, sorbitol, water

Adverse reaction

*This product is not manufactured or distributed by Chattem, Inc., distributor of Act

Distributed by:

Family Dollar Services, Inc.

10401 Monroe Rd.

Matthews, NC 28105 USA

Made in USA

004.002/004AE

principal display panel

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

COMPARE TO THE ACTIVE INGREDIENT OF ACT ANTICAVITY KIDS FLUORIDE RINSE

FAMILY

WELLNESS

100% SATISFACTION GUARANTEED OR YOUR MONEY BACK

Kid's

Anti-Cavity

Fluoride

Rinse

Alcohol Free

Strong Cavity Protection

BUBBLE GUM

IMPORTANT: READ DIRECTIONS FOR PROPER USE

18 FL OZ (532 mL)

INGREDIENTS AND APPEARANCE

ANTICAVITY RINSE 
sodium fluoride mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55319-004
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
BENZYL ALCOHOL (UNII: LKG8494WBH)
EDETATE CALCIUM DISODIUM ANHYDROUS (UNII: 8U5D034955)
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
POLOXAMER 407 (UNII: TUF2IVW3M2)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM PHOSPHATE (UNII: SE337SVY37)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SORBITOL (UNII: 506T60A25R)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55319-004-44	500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/02/2011

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	08/02/2011

Labeler - Family Dollar Services, Inc (024472631)

Registrant - Vi Jon, Inc. (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi Jon, Inc.		790752542	manufacture(55319-004)