ORAL ANTIVAVITY- sodium fluoride mouthwash

Oral Antivavity by

Drug Labeling and Warnings

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

Drug Details [pdf]

claims

Kroger

FROM OUR FAMILY TO YOURS

Refreshing

Mint

ALCOHOL FREE FLUORIDE MOUTHWASH

Active ingredient

Sodium fluoride 0.0219% (0.01% w/v 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 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 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 witout supervision
• children under 6 years of age: consult a dentist or doctor

Inactive ingredients

water, glycerin, flavor, cetlpyridinium chloride, poloxamer 407, phosphoric acid, methylparaben, sodium saccharin, propylparaben, propylene glycol, disodium phosphate, blue 1

Questions or comments?

1-800-632-6900

Claims

This rinse may cause temporary staining to the surface of teeth.  This is not harmful, and adequate brushing may prevent its occurrence.

Disclaimer

CREST IS A REGISTERED TRADEMARK OF THE PROCTER & GAMBLE COMPANY, CINCINNATI, OHIO 45202.  THE PROCTER & GAMBLE COMPANY IS NOT AFFILIATED WITH THE KROGER CO. OR THIS PRODUCT.

Adverse Reactions

DISTRIBUTED BY THE KROGER CO., OHIO 452020

QUALITY GUARANTEE

www.kroger.com

576.00/576AA

principal display panel

COMPARE TO

the active ingredient of

CREST PRO-HEALTH COMPLETE

ANTICAVITY FLUORIDE RINSE

See Back Label

Kroger

Refreshing Mint

ALCOHOL-FREE

FLUORIDE MOUTHWASH

ANTICAVITY FLUORIDE RINSE

IMPORTANT: read directions for proper use.

• Helps Prevent Cavities
• Helps Make Enamel Stronger
• Helps Clean the Entire Mouth
• Helps Kill Germs that Cause Bad Breath
• Helps Freshen Breath
• No Alcohol Burn

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

33.8 FL OZ (1 L)

INGREDIENTS AND APPEARANCE

ORAL ANTIVAVITY 
sodium fluoride mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 30142-576
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	10.41 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)
POLOXAMER 407 (UNII: TUF2IVW3M2)
PHOSPHORIC ACID (UNII: E4GA8884NN)
METHYLPARABEN (UNII: A2I8C7HI9T)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 30142-576-86	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/06/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	02/06/2015

Labeler - Kroger Co (006999528)

Registrant - Vi-Jon (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi-Jon		790752542	manufacture(30142-576)