ANTICAVITY- sodium fluoride mouthwash

Anticavity by

Drug Labeling and Warnings

Anticavity by is a Otc medication manufactured, distributed, or labeled by Demoulas Super Markets, Inc., Vi Jon. 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 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 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

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

Other information

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

SPL UNCLASSIFIED SECTION

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

DISTRIBUTED BY
DEMOULAS SUPER MARKETS, INC
875 EAST STREET
TEWKSBURY, MA 01876

DSP-TN-15000 DSP-MO-34 SDS-TN-15012

principal display panel

Sealed With Printed Neckband For Your Protection

MARKET BASKET

MORE FOR YOUR DOLLAR

Compare to Listerine Total Care Anticavity Mouthwash*

ANTICAVITY MOUTHWASH

Sodium Fluoride and Acidulated Phosphate Topical Solution

Eucalyptus Mint

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

IMPORTANT: Read directions for proper use.

1L (33.8 FL OZ)

163.004/163AE

INGREDIENTS AND APPEARANCE

ANTICAVITY 
sodium fluoride mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53942-163
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)
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: 53942-163-86	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/13/2006

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	05/13/2006

Labeler - Demoulas Super Markets, Inc. (007869647)

Registrant - Vi Jon (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi Jon		790752542	manufacture(53942-163)