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Anticavity by TOPCO ASSOCIATES LLC

Medically reviewed on April 24, 2018

Dosage form: mouthwash
Ingredients: SODIUM FLUORIDE 0.2mg in 1mL
Labeler: TOPCO ASSOCIATES LLC
NDC Code: 36800-803

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.

Glowing White Anticavity Mouthrinse

Active Ingredient

Sodium fluoride 0.02% (0.01% 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 (8%), hydrogen peroxide, poloxamer 407, sodium saccharin, sucralose, menthol, phosphoric acid, disodium phosphate, flavor

Other information
  • store at room temperature (59º-77ºF)

other information

Contains peroxide which releases oxygen while whitening.  This may cause the bottle to inflate slightly or release air when opened.

Disclaimer

*This product is not manufactured or distributed by Johnson & Johnson Healthcare Products, distributor of Listerine Healthy White Vibrant Anticavity Mouthrinse

Adverse reactions

DISTRIBUTED BY TOPCO ASSOCIATES, LLC

ELK GROVE VILLAGE, IL 60007

topcare@topco.com    www.topcarebrand.com

435.000/435AA

Principal Display Panel

TopCare

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

FRESH MINT FLAVOR

Glowing

White

Anticavity

Mouthrinse

  • Begins working on contact
  • 5 days to whiter teeth
  • Helps strengthen teeth
  • Kills germs that cause bad breath

IMPORTANT:

read direction for proper use.

COMPARE TO LISTERINE HEALTHYWHITE ANTICAVITY MOUTHRINSE active ingredient

16 FL OZ (1 PT) 474 mL

ANTICAVITY 
sodium fluoride mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-803
Route of AdministrationoralDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION0.2 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
ALCOHOL 
HYDROGEN PEROXIDE 
POLOXAMER 407 
SACCHARIN SODIUM 
SUCRALOSE 
MENTHOL 
PHOSPHORIC ACID 
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS 
Packaging
#Item CodePackage Description
1NDC:36800-803-45946 mL in 1 BOTTLE, PLASTIC
2NDC:36800-803-43474 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35509/15/2015
Labeler - TOPCO ASSOCIATES LLC (006935977)
Registrant - Vi-Jon, Inc. (790752542)
Establishment
NameAddressID/FEIOperations
Vi-Jon, Inc.790752542manufacture(36800-803)

 
TOPCO ASSOCIATES LLC

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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