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Mouth Rinse by Topco associates LLC

Medically reviewed on October 5, 2017

Dosage form: mouthwash
Ingredients: SODIUM FLUORIDE 0.1mg in 1mL
Labeler: Topco associates LLC
NDC Code: 36800-001

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 Mouthwash

Active Ingredient

Sodium fluoride 0.0221% (0.01% 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 under 12 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 and then spit out

•do not swallow the rinse

•do not eat or drink anything 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 - 25⁰C (68⁰ - 77⁰ F)

•cold weather may temporarily cloud this product

Inactive ingredients

water, sorbitol solution, alcohol (21.6%), flavors, poloxamer 407 sodium lauryl sulfate, phosphoric acid, sucralose and /or sodium saccharin, dibasic sodium phosphate, D+C red no.33, FD+C blue no.1, FD+C yellow no. 6

Disclaimer

*This product is not manufactured or distributed by Johnson + Johnson Healthcare Products, distributed of Listerine Total Care

DISTRIBUTED BY TOPCO ASSOCIATES LLC
7711 GROSS POINT ROAD, SKOKIE, IL 60077
TOPCO VIJ910
QUESTIONS? 1-888-423-0139 topcare@topco.com
This TOP CARE product is laboratory tested to guarantee its hightes quality. Your total satisfaction is guaranteed
DSP-TN 15000
DSP-MO-34
SDS-TN-15012

Principal Display Panel

Sealed With Printed Neckband For Your Protection

Kills Germs and Freshens Breath

IMPORTANT: read directions for proper use.

Anticavity Mouthwash

SODIUM FLUORIDE AND ACIDULATED PHOSPHATE TOPICAL  SOLUTION

  • Helps prevent cavities
  • Restores enamel
  • Helps strengthen teeth
  • Helps kill germs that casue bad breath
  • Freshens breath

Eucalyptus Mint

COMPARE TO ACTIVE INGREDIENT OF LISTERINE TOTAL CARE ANTICAVITY MOUTHWASH

1 L (33.8 FL OZ)

163.004/163AE

MOUTH RINSE 
sodium fluoride mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-001
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 
SORBITOL 
ALCOHOL 
POLOXAMER 407 
SODIUM LAURYL SULFATE 
PHOSPHORIC ACID 
SUCRALOSE 
SODIUM PHOSPHATE, DIBASIC 
D&C RED NO. 33 
FD&C BLUE NO. 1 
FD&C YELLOW NO. 6 
Packaging
#Item CodePackage Description
1NDC:36800-001-861000 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35512/30/2010
Labeler - Topco associates LLC (006935977)
Registrant - Vi Jon (790752542)
Establishment
NameAddressID/FEIOperations
Vi Jon790752542manufacture(36800-001)

 
Topco associates 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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