ANTICAVITY FLUORIDE RINSE- sodium fluoride mouthwash

Anticavity fluoride rinse by

Drug Labeling and Warnings

Anticavity fluoride rinse by is a Otc medication manufactured, distributed, or labeled by Topco Associates LLC, Nice-Pak Products, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Sodium fluoride 0.05% (0.02% w/v fluoride ion)

Purpose

Anticavity

Use

aids in the prevention of dental cavities

Warning

For this product

Keep out of reach of children.

If more than used for rinsing is accidentally swallowed, seek professional assistance or contact a Poison Control Center immediately.

Directions

• adults and children 6 years of age and older: use once a day after brushing your teeth with a toothpaste
• remove cap
• pour 10 milliliters (10 ML mark on inside of cap); do not fill above 10 ML mark
• vigorously swish 10 milliliters 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

Other information

• store at room temperature

Inactive ingredients

water, glycerin, sodium benzoate, potassium sorbate, flavor, xylitol, citric acid, sucralose, sodium citrate

Questions or comments?

1-888-423-0139

TAMPER EVIDENT STATEMENT

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

ADVERSE REACTIONS

DISTRIBUTED BY TOPCO ASSOCIATES LLC

ITASCA, IL 60143 ©TOPCO VIJA0624

QUESTIONS? 1-888-423-0139

topcare@topco.com www.topcarebrand.com

Scan here for more information or call 1-888-423-0139

QUALITY GUARANTEED

Disclaimer

*This product is not manufactured or distributed by Dr. Harold Katz, LLC., distributor of TheraBreath ®for Kids! Oral Rinse 

PRINCIPAL DISPLAY PANEL

COMPARE TO THERABREATH ® FOR KIDS! ORAL RINSE*

TopCare ®

everyday

Kids Anticavity

Fluoride Oral Rinse

Watermelon Flavored

• Helps prevent cavites & strengthens teeth
• Dye, Paraben, Alcohol, and Sugar Free

IMPORTANT: read directions for proper use.

10 FL OZ (296 mL)

INGREDIENTS AND APPEARANCE

ANTICAVITY FLUORIDE RINSE 
sodium fluoride mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76162-838
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)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM BENZOATE (UNII: OJ245FE5EU)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
XYLITOL (UNII: VCQ006KQ1E)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SUCRALOSE (UNII: 96K6UQ3ZD4)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76162-838-38	296 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/06/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M021	09/06/2024

Labeler - Topco Associates LLC (006935977)

Registrant - Nice-Pak Products, LLC (119091520)

Establishment
Name	Address	ID/FEI	Business Operations
Nice-Pak Products, LLC		119091514	manufacture(76162-838)