ORAL ANTIVAVITY- sodium fluoride mouthwash

Oral Antivavity by

Drug Labeling and Warnings

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

Drug Details [pdf]

claims

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECION

TopCare

everyday

• Helps strengthen enamel
• Helps prevent cavities
• Kills bad breath germs
• Freshen Breath

active ingredient

Sodium fluoride 0.0219% (0.01% w/v 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 6 years of age and older:

• use twice daily 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, sodium saccharin, phosphoric acid, sodium benzoate, sucralose, poloxamer 407, benzoic acid, disodium phosphate, propylene glycol, blue 1

Questions?

Call 1-888-423-0139

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY TOPCO ASSOCIATES LLC

ELK GROVE VILLATE, IL 60007

©TOPCO VIJA0122  QUESTIONS? 1-888-423-0139

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

This product is not manufactured or distributed by Procter & Gamble, distributof of Crest Pro-Health Advanced Anticavity Fluoride Mouthwash

This product is not intended to replace brushing or flossing

Principal display panel

COMPARE TO CREST PRO-HEALTH ADVANCED ANTICAVITY FLUORIDE MOUTHWASH

TopCare

everyday

ALOHOL FREE

Fluoride

Anticavity Mouthwash

REFRESHING MINT

• Helps strengthen enamel
• Helps prevent cavities
• Cleans teeth**
• Kills bad breath germs
• Freshens breath
• Helps keep mouth feeling clean

IMPORTANT: Read directions for proper use.

33.8 FL OZ (1 QT 1.8 FL OZ) 1 L

INGREDIENTS AND APPEARANCE

ORAL ANTIVAVITY 
sodium fluoride mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76162-576
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)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
PHOSPHORIC ACID (UNII: E4GA8884NN)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SUCRALOSE (UNII: 96K6UQ3ZD4)
POLOXAMER 407 (UNII: TUF2IVW3M2)
BENZOIC ACID (UNII: 8SKN0B0MIM)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76162-576-86	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/04/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M021	04/04/2022

Labeler - Topco (006935977)

Registrant - Consumer Product Partners, LLC (119091520)

Establishment
Name	Address	ID/FEI	Business Operations
Consumer Product Partners, LLC		119091514	manufacture(76162-576)