ANTICAVITY- sodium fluoride mouthwash

Anticavity by

Drug Labeling and Warnings

Anticavity by is a Otc medication manufactured, distributed, or labeled by Kroger , 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, alcohol (21.6 %v/v), sorbitol, poloxamer 407, eucalyptol, flavor, methyl salicylate, menthol, phosphoric acid, sodium saccharin, thymol, disodium phosphate, sucralose, red 40, blue 1

Other information

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

SPL UNCLASSIFIED SECTION

Comments or Questions?
800-632-6900 or
www.korger.com
DISTRIBUTED BY
THE KROGER CO.
CINCINNATI, OH 45202

*Listerine is a registered trademark of Johnson & Johnson Healthcare Products, New Brunswick, NJ 08933.  Johnson & Johnson Healthcare Products is not affiliated with The Kroger Co. or this product.

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

principal display panel

Compare to the active ingredient in Listerine Total Care Anticavity Mouthwash* See back label

Kroger

Eucalyptus mint

ANICAVITY MOUTH RINSE

sodium fluoride and acidulated phosphate topical solution

helps prevent cavities

Restores enamel

Helps strengthen teeth

Kills germs that cause bad breath

Freshens breath

Sealed with printed neckband for your protection

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: 30142-163
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)
ALCOHOL (UNII: 3K9958V90M)
SORBITOL (UNII: 506T60A25R)
POLOXAMER 407 (UNII: TUF2IVW3M2)
EUCALYPTOL (UNII: RV6J6604TK)
METHYL SALICYLATE (UNII: LAV5U5022Y)
MENTHOL (UNII: L7T10EIP3A)
PHOSPHORIC ACID (UNII: E4GA8884NN)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
THYMOL (UNII: 3J50XA376E)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
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: 30142-163-86	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/12/2005

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	09/12/2005

Labeler - Kroger (006999528)

Registrant - Vi Jon (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi Jon		790752542	manufacture(30142-163)