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Anticavity by Foodhold U.S.As., LLC

Medically reviewed on March 14, 2018

Dosage form: mouthwash
Ingredients: SODIUM FLUORIDE 0.2mg in 1mL
Labeler: Foodhold U.S.As., LLC
NDC Code: 41520-435

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.

Whitening Anticavity Mouth Rinse

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)

Disclaimer

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

Adverse Reactions

DISTRIBUTED BY:

FOODHOLD U.S.A., LLC

LANDOVER, MD 20785

S & S brands, LLC

1-887846-8484

Quality Guaranteed or your money back

435.000/435AA

Principal Display Panel

Compare to Listerine Healthy White Vibrant Anticavity Mouthrinse

Sealed With Printed Neckband For Your Protection

IMPORTANT: read directions for proper use.

Care One

GLOWING WHITE

ANTICAVITY

MOUTHRINSE

FRESH MINT FLAVOR

  • Begins Working On Contact
  • 5 days to Whiter Teeth
  • Helps Strengthen Teeth
  • Kills Germs that Cause Bad Breqath

16 FL OZ (473 mL)

ANTICAVITY 
sodium fluoride mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-435
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:41520-435-45946 mL in 1 BOTTLE, PLASTIC
2NDC:41520-435-43473 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35506/01/2015
Labeler - Foodhold U.S.As., LLC (809183973)
Registrant - Vi-Jon, Inc. (790752542)
Establishment
NameAddressID/FEIOperations
Vi-Jon, Inc.790752542manufacture(41520-435)

 
Foodhold U.S.As., 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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