Anticavity Rinse Fluoride Rinse

Dosage form: mouthwash
Ingredients: Sodium Fluoride .0221kg in 100L
Labeler: American Sales Company
NDC Code: 41520-344

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.

Drug Facts

 Active ingrident                                          Purpose                                      

Sodium fluoride 0.0221% (0.01% w/v fluoride ion)         Anticavity

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 right away.

Directions

•adults and children 6 years of age and older: use twice a day after brushing your teeth with a toothpaste

•remove cap

•pour 10 milliliters (10 mL mare 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 years of age: consult a dentist or doctor.




Other information store at 20⁰ to 25⁰ C (68⁰ to 77⁰ F)


Inactive ingredients water, sorbitol solution, propylene glycol, flavors, phosphoric acid, sucralose, cetylpridinium chloride, disodium phosphate, methylparaben, propylparaben, yellow 6, blue1

For Kids Anticavity

Fluoride Rinse

Mint Flavor 

Sealed With Printed Neckband For Your Protection

•Kill germs that cause bad breath

•Helps Prevent cavities

•Alcohol Free

16.9 FL OZ (500 mL)

IMPORTANT: Read directions for proper use.



ANTICAVITY RINSE FLUORIDE RINSE 
anticavity rinse mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-344
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sodium Fluoride (FLUORIDE ION) Sodium Fluoride .0221 kg  in 100 L
Product Characteristics
Color    Score    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:41520-344-77.5 L in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35509/05/2009
Labeler - American Sales Company (809183973)
Registrant - Vi Jon (790752542)
Establishment
NameAddressID/FEIOperations
Vi Jon790752542manufacture

Revised: 05/2010
 
American Sales Company

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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