Anticavity Fluoride Rinse

Anticavity Fluoride Rinse

Drug Labeling and Warnings

Drug Details

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ANTICAVITY RINSE- sodium fluoride mouthwash 
Family Dollar Services, Inc

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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Anticavity Fluoride Rinse

Active ingredient

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

Purpose

Anticavity Rinse

Use

aids in the prevention of dental cavities

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)

image description

ANTICAVITY RINSE 
sodium fluoride mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 55319-004
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.2 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 55319-004-44500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/02/2011
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35508/02/2011
Labeler - Family Dollar Services, Inc (024472631)
Registrant - Vi Jon, Inc. (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi Jon, Inc.790752542manufacture(55319-004)

Revised: 2/2019
 
Family Dollar Services, Inc


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