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Anticavity Fluoride Rinse by Family Dollar Services, Inc

Dosage form: mouthwash
Ingredients: SODIUM FLUORIDE 0.1mg in 1mL
Labeler: Family Dollar Services, Inc
NDC Code: 55319-163

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.

Drug Facts

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 12 years of age and older:

  • use twice daily after brushing your teeth with 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
  • supervise children as necessary until capable of using without supervision
  • children under 12 years of age: consult a dentist or doctor

Other information
  • store at controlled room temperature 20⁰ -25⁰ C (68⁰ - 77⁰ 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, phosphori acid, sucralose, menthol, disosium phosphate, red 40, blue 1

Disclaimer

This product is not manufacturd or distributed by Johnson + Johnson Healthcare Products,  owner of the registered trademark Listerine*

DISTRIBUTED BY:
FAMILY DOLLAR SERVICES, INC
10401 MONROE RD
MATTHEWS, NC 28105

Principal Display Panel

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

FAMILY WELLNESS

COMPARE TO THE ACTIVE INGREDIENT OF LISTERINE TOTAL CARE ANTICAVITY MOUTHWASH

Anticavity Fluoride Mouthwash

Sodium Fluoride and Acidulated Phosphate Topical Solution

Helps Prevent Cavities

Strengthen Teeth and Kill Germs That Cause Bad Breath

Cleans Entire Mouth and Freshens Breath

Restores Enamel

EUCALYPTUS MINT

IMPORTANT: READ DIRECTIONS FOR PROPER USE

1 L (33.8 FL OZ)

163.004/163AE

ANTICAVITY FLUORIDE RINSE 
sodium fluoride mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55319-163
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 
PHOSPHORIC ACID 
sucralose 
MENTHOL 
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS 
FD&C RED NO. 40 
FD&C BLUE NO. 1 
Packaging
#Item CodePackage Description
1NDC:55319-163-861000 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35512/14/2011
Labeler - Family Dollar Services, Inc (024472631)
Registrant - Vi Jon (790752542)
Establishment
NameAddressID/FEIOperations
Vi Jon790752542manufacture(55319-163)

Revised: 10/2017
 
Family Dollar Services, Inc

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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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