ANTICAVITY- sodium fluoride mouthwash

Anticavity by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active Ingredient

Sodium fluoride 0.02% (0.01% w/v fluoride ion)

Purpose

Anticavity

Use

Aids in the prevention of dental cavities

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 6 years of age and older:

• use twice a day 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 for 30 minutes after rinsing
• instruct children under 12 years of age in good rinsing habits (to minimize swallowing)
• supervise children as necessary until capable of using without supervision
• children under 6 years of age: consult a dentist or doctor

Inactive ingredients

water, alcohol (8%), hydrogen peroxide, poloxamer 407, sodium saccharin, sucralose, menthol, phosphoric acid, disodium phosphate, flavor

Other information

• store at room temperature (59º-77ºF)

OTHER SAFETY INFORMATION

Contains peroxide which releases oxygen while whitening.  This may cause the bottle to inflate slightly or release air when opened.

*Listerine is a registered trademark of Johnson & Johnson Healthcare Products, New Brunswick, NJ 08903.  Johnson & Johnson Healthcare Products is not affiliated with The Kroger Co. or this product.

DISTRIBUTED BY

The Kroger Co.

Cincinnatti, OH 45202

800-632-6900 www.kroger.com

DSP-TN-15000

DSP-MO-34

SDS-TN-15012

PRINCIPAL DISPLAY PANEL

Compare to the ingrdients of Listerine Healthy White Vibrant Anticavity Mouthrinse *See back label

Fresh Mint

Whitening Anticavity Mouthrinse

Safely whitens teeth

Kills germs that cause bad breath

Helps strengthen teeth

Sealed with printed neckband for your protection

IMPORTANT: Read directions for proper use

946 mL (32 FL OZ)

INGREDIENTS AND APPEARANCE

ANTICAVITY 
sodium fluoride mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 30142-435
Route of Administration	oral

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.2 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
HYDROGEN PEROXIDE (UNII: BBX060AN9V)
POLOXAMER 407 (UNII: TUF2IVW3M2)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SUCRALOSE (UNII: 96K6UQ3ZD4)
MENTHOL (UNII: L7T10EIP3A)
PHOSPHORIC ACID (UNII: E4GA8884NN)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 30142-435-45	946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	09/15/2015

Labeler - Kroger Co (006999528)

Registrant - Vi-Jon, Inc. (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi-Jon, Inc.		790752542	manufacture(30142-435)