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Anticavity by DOLGENCORP, LLC

Dosage form: rinse
Ingredients: SODIUM FLUORIDE 10.4mg in 1mL
Labeler: DOLGENCORP, LLC
NDC Code: 55910-030

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.

Anticavity Fluoride Rinse

Active ingredient

Sodium fluoride 0.05% (0.02% 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, see professional assistance or contact a Poison Control Center immediately.

Directions
  • adults and children 6 years of age and older: use once a day after brushing your teeth with toothpaste
  • remove cap
  • pour 10 milliliters (10 mL mark on inside of cap); do not fill above 10 mL mark
  • vigorously swish 10 millilitrs 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 year of age: consult a dentist or doctor

Other information
  • store at room temperture

Inactive ingredients

benzyl alcohol, calcium disodium EDTA, disodium phosphate, flavor, poloxamer 407, polysorbate 80, propylene glycol, red 33, sodium benzoate, sodium phosphate, sodium saccharin, sorbitol, water

Sealed with printed neckband for your protection

*This product is not manufactured or distributed by Chattem, Inc., distributor of Act Bubblegum Blowout Anticavity Kids Fluoride Rinse.

DISTRIBUTED BY DOLGENCORP, LLC, 100 MISSION RIDGE, GOODLETTSVILLE, TN 37072

100% Satisfaction Guaranteed! (888) 309-9030

Principal display panel

DG health

Compare to Act Bubblegum Blowout Anticavity Kids Fluoride Rinse*

KIDS

Anticavity Fluoride Rinse

Strong Cavity Protection

Helps Strengthen Teeth

Alcohol Free

Bubblegum Flavor

IMPORTANT: Read directions for proper use

16.9 FL OZ (500 mL)

004.001/004AE

ANTICAVITY 
sodium fluoride rinse
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55910-030
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION10.4 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BENZYL ALCOHOL 
EDETATE CALCIUM DISODIUM ANHYDROUS 
CETYLPYRIDINIUM CHLORIDE 
EDETATE DISODIUM 
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS 
POLOXAMER 407 
POLYSORBATE 80 
PROPYLENE GLYCOL 
D&C RED NO. 33 
SODIUM BENZOATE 
SODIUM PHOSPHATE 
SACCHARIN SODIUM 
SORBITOL 
WATER 
Packaging
#Item CodePackage Description
1NDC:55910-030-77500 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35502/24/2015
Labeler - DOLGENCORP, LLC (068331990)
Registrant - Vi-Jon (790752542)
Establishment
NameAddressID/FEIOperations
Vi-Jon790752542manufacture(55910-030)

Revised: 01/2018
 
DOLGENCORP, LLC

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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