MOUTH RINSE- sodium fluoride mouthwash

Mouth Rinse by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active Ingredients

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, alcohol (21.6%), flavors, poloxamer 407 sodium lauryl sulfate, phosphoric acid, sucralose, dibasic sodium phosphate, FD+C yellow no.6, FD+C red no. 40, FC+C blue no.1

Questions

 Call 1-888-593-0593

SPL UNCLASSIFIED SECTION

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, distributed of Listerine Total Care Anticavity Mouthwash.*

DISTRIBUTED BY: WALGREEN CO.
200 WILMOT RD, DEERFIELD, IL 60015
100% SATISFACTION GUARANTEED
walgreens.com
MADE IN THE U.S.A. WITH U.S. AND FOREIGN COMPONENTS

Principal Display Panel

Well at Walgreens

ANTICAVITY Mouth Rinse

Sodiu Fluoride + Acidulated Phosphate Topical Solution

• Helps prevent cavities + strengthen teeth
• Help kill germs that cause bad breath
• Restores enamel + freshen breath
• IMPORTANT: Read directions for proper use

EUCALYPTUS MINT

Compare to Listerie Total Care Anticavity Mouthwash Active Ingredient*

33.8 FL OZ (1 L)

163.004/163AE

INGREDIENTS AND APPEARANCE

MOUTH RINSE 
sodium fluoride mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0363-0163
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)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0363-0163-86	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/15/2006

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	03/15/2006

Labeler - Walgreen (008965063)

Registrant - Vi Jon (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi Jon		790752542	manufacture(0363-0163)