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Anticavity by Big Lots

Medically reviewed on October 5, 2017

Dosage form: mouthwash
Ingredients: SODIUM FLUORIDE 0.1mg in 1mL
Labeler: Big Lots
NDC Code: 50594-163

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 0.0221% (0.01% w/v fluoride ion)

Purpose

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, get medical help or contact a Poison Control Center right away.

Directions

Adults and Children 6 years of age and older:

  • use twice daily after brushing your teeth with a toothpaste
  • vigorously swish 10 mL (2 teaspoonfuls) 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 uder 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 controlled room temperature 20°-25° C to (68° - 77°F)
  • cold weather may temporarily cloud this product

Inactive ingredients

water, alcohol (21.6%), sorbitol, poloxamer 407, sodium lauryl sulfate, eucalyptol, flavor, methyl salicylate, thymol, phosphoric acid, sucralose, menthol, disodium posphate, red 40, blue 1

Questions

Call 1-888-593-0593

Sealed with printed neckband for your protection.
Do not use if band around cap is broken or missing.

*This product is not manufactured or distributed by Johnson & Johnson Healthcare Products, distributor of Listerine Total Care Fresh Mint Anticavity Mouthwash

Manufactured for Big Lots by Vi-Jon, Inc
8515 Page Avene St. Louis, MO 63114

Principal Display Panel

SOUND BODY

COMPARE TO LISTERINE TOTAL CARE ANTICAVITY MOUTHWASH

ANTICAVITY FLUORIDE RINSE

Sodium Fluoride and Acidulated Phosphate Topical Solution

ANTICAVITY FLUORIDE MOUTHWASH

  • Helps strengthen teeth to help prevent cavities
  • Helps restore enamel
  • Kills germs that cause bad breath
  • Freshens breath
  • Cleans the entire mouth
  • Helps prevent cavities

IMPORTANT: read directions for proper use

EUCALYPTUS MINT

1L (33.8 FL OZ)

163.004/163AE

ANTICAVITY 
sodium fluoride mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50594-163
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION0.1 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
ALCOHOL 
SORBITOL 
POLOXAMER 407 
SODIUM LAURYL SULFATE 
EUCALYPTOL 
METHYL SALICYLATE 
THYMOL 
PHOSPHORAMIDIC ACID 
SUCRALOSE 
MENTHOL 
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS 
FD&C RED NO. 40 
FD&C BLUE NO. 1 
Packaging
#Item CodePackage Description
1NDC:50594-163-861000 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35503/17/2016
Labeler - Big Lots (017885351)
Registrant - Vi Jon (790752542)
Establishment
NameAddressID/FEIOperations
Vi Jon790752542manufacture(50594-163)

 
Big Lots

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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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