ANTICAVITY- sodium fluoride mouthwash

Anticavity by

Drug Labeling and Warnings

Anticavity by is a Otc medication manufactured, distributed, or labeled by TOPCO ASSOCIATES LLC, Vi-Jon, LLC. 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

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 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 information

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

Disclaimer

*This product is not manufactured or distributed by Johnson & Johnson Healthcare Products, distributor of Listerine Healthy White Vibrant Anticavity Mouthrinse

Adverse reactions

DISTRIBUTED BY TOPCO ASSOCIATES, LLC

ELK GROVE VILLAGE, IL 60007

topcare@topco.com    www.topcarebrand.com

435.000/435AA

Principal Display Panel

TopCare

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

FRESH MINT FLAVOR

Glowing

White

Anticavity

Mouthrinse

• Begins working on contact
• 5 days to whiter teeth
• Helps strengthen teeth
• Kills germs that cause bad breath

IMPORTANT:

read direction for proper use.

COMPARE TO LISTERINE HEALTHYWHITE ANTICAVITY MOUTHRINSE active ingredient

16 FL OZ (1 PT) 474 mL

INGREDIENTS AND APPEARANCE

ANTICAVITY 
sodium fluoride mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 36800-803
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: 36800-803-45	946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/15/2015
2	NDC: 36800-803-43	474 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/15/2015

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

Labeler - TOPCO ASSOCIATES LLC (006935977)

Registrant - Vi-Jon, Inc. (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi-Jon, Inc.		790752542	manufacture(36800-803)