ANTICAVITY- sodium fluoride mouthwash

Anticavity by

Drug Labeling and Warnings

Anticavity by is a Otc medication manufactured, distributed, or labeled by Wal-Mart Stores, Inc., Vi-Jon, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Sealed with printed neckband for your protection

ACTIVE INGREDIENT

Active ingredient
Sodium fluoride 0.0221% (0.01% fluoride ion)

Purpose
Anticavity

INDICATIONS & USAGE

Use aids in the prevention of dental cavities

WARNINGS

Warning

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.

DOSAGE & ADMINISTRATION

Directions
Adults and children 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 minutes 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

STORAGE AND HANDLING

Other Information
store at controlled room temperature 20⁰ - 25⁰C (68⁰ - 77⁰ F)
cold weather may temporarily cloud this product

INACTIVE INGREDIENT

Inactive ingredients water, sorbitol solution, alcohol (21.6%), flavors, poloxamer 407, sodium lauryl sulfate, phosphoric acid, dibasic sodium phosphate, sodium saccharin, surcalose, FD+C red 40, FD+C blue no.1

SPL UNCLASSIFIED SECTION

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

DSP-TN-1500
DSP-MO-34
SDS-TN-15012

ADVERSE REACTIONS

Distributed by: Wal-Mart Stores, Inc.
Bentonville, AR 72716

Satisfaction guaranteed-for questions or comments please call 1-888-287-1915

PRINCIPAL DISPLAY PANEL

IMPORTANT: READ DIRECTIONS FOR PROPER USE
Compare to the active ingredient in Listerine Icy Mint Total Care Anticavity Mouthwash
Anticavity
Mouthwash
Multiple Benefits in One
Helps prevent cavities
Restores minerals to enamel
Helps strengthen teeth
Helps kill bad breath germs
Freshens breath
Leaves the mouth feeling clean
Sodium Fluorde and
AcidulatedPhosphate
Topical Solution
ICE MNT
1 Litter (33.8 FL OZ)

INGREDIENTS AND APPEARANCE

ANTICAVITY 
sodium fluoride mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49035-966
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	SODIUM FLUORIDE	0.02 kg  in 100 L

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
POLOXAMER 407 (UNII: TUF2IVW3M2)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
PHOSPHORIC ACID (UNII: E4GA8884NN)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49035-966-86	1 L in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	08/19/2010

Labeler - Wal-Mart Stores, Inc. (051957769)

Registrant - Vi-Jon, Inc (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi-Jon, Inc		790752542	manufacture