ANTICAVITY RINSE- sodium fluoride mouthwash

Anticavity Rinse by

Drug Labeling and Warnings

Anticavity Rinse by is a Otc medication manufactured, distributed, or labeled by CVS Pharmacy, Inc, Vi-Jon, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

claims

No-drip spout for precise pouring every time.
Improved stable cap/cup for personal rinsing.

Active ingredient

Sodium fluoride 0.0221% (0.01% fluoride ion)

Purpose

Anticavity

Use

aids in the prevention of dental cavities

Warnings

for this product

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 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

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, dibasic sodium phosphate, sodium saccharin, surcalose, FD&C red 40, FD&C blue no.1

Disclaimer

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 section

CVS Quality

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

2011 CVS/Pharmacy

www.cvs.com

1-800-shop-CVS

principal display panel

CVS

pharmacy

Compare to the

active ingredient

in Listerine

EASY

POUR

SPOUT

ANTICAVITY

FLUORIDE

RINSE

STRENGTHENS TEETH

SODIUM FLUORIDE & ACIDULATED

PHOSPHATE TOPICAL SOLUTION

• Helps prevent cavities
• Kills germs that cause plaque & bad breath
• Restores minerals to enamel
• Freshens breath

ICE MINT

NO

MESS

CAP

1 L (33.8 FL OZ)

INGREDIENTS AND APPEARANCE

ANTICAVITY RINSE 
sodium fluoride mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59779-966
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	10.33 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, UNSPECIFIED FORM (UNII: GR686LBA74)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SUCRALOSE (UNII: 96K6UQ3ZD4)
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: 59779-966-86	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/19/2010

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

Labeler - CVS Pharmacy, Inc (062312574)

Registrant - Vi-Jon, Inc (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi-Jon, Inc		790752542	manufacture(59779-966)