MOUTH RINSE- sodium fluoride mouthwash

Mouth Rinse by

Drug Labeling and Warnings

Mouth Rinse by is a Otc medication manufactured, distributed, or labeled by Topco associates LLC, Vi Jon, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Sodium fluoride 0.0221% (0.01% fluoride ion)

Purpose

Anticavity

Use

aids in the prevention of dental cavities

WARNINGS

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)

INGREDIENTS AND APPEARANCE

MOUTH RINSE 
sodium fluoride mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 36800-001
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.1 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
ALCOHOL (UNII: 3K9958V90M)
POLOXAMER 407 (UNII: TUF2IVW3M2)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
PHOSPHORIC ACID (UNII: E4GA8884NN)
SUCRALOSE (UNII: 96K6UQ3ZD4)
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 36800-001-86	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/30/2010

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	12/30/2010

Labeler - Topco associates LLC (006935977)

Registrant - Vi Jon (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi Jon		790752542	manufacture(36800-001)