ORAL ANTIVAVITY- sodium fluoride mouthwash

Oral Antivavity by

Drug Labeling and Warnings

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

Drug Details [pdf]

TEP

Sealed with printed neckband for your protection

Active ingredient

Sodium fluoride 0.02% (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 bwtween 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, cetylpyridinium chloride, poloxamer 407, phosphoric acid, methylparaben, sodium saccharin, propylparaben, propylene glycol, disodium phosphate, blue 1

Claims

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

disclamer

This product is not manufactured or distributed by The Procter & Gamble Company, owner of the trademarks Crest and Pro-Health Advanced Anticavity Fluoride Mouthwash

Adverse Reactions

DISTRIBUTED BY

MEIJER DISTRIBUTION, INC.

GRAND RAPIDS, MI 49544

www.meijer.com

576.000/576AB

Principal Display Panel

Compare to Crest Pro-Health

active ingredient

meijer

Refreshing Mint

OralRinse

anticavity

6 Benefits:

Kills bad breath germs

Helps prevent cavities 

Helps strengthen enamel

Cleans teeth

Freshen breath

Alcohol free

IMPORTANT: read directions for proper use

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: 41250-576
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)
BENZOIC ACID (UNII: 8SKN0B0MIM)
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: 41250-576-86	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 - Meijer Distribution, Inc (006959555)

Registrant - Vi-Jon (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi-Jon		790752542	manufacture(41250-576)