FDA.reportPublic FDA data

Anticavity fluoride rinse

Manufacturer
Topco Associates LLC | Nice-Pak Products, LLC
Effective date
2026-02-13
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:44:26

Label at a glance#

ProductAnticavity fluoride rinse
Active ingredientSODIUM FLUORIDE
Label structure13 sections

Dosage and administration

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 ...

Storage and handling

store at room temperature

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

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

Purpose

OTC - PURPOSE SECTION

Anticavity

Use

INDICATIONS & USAGE SECTION

aids in the prevention of dental cavities

Warning

WARNINGS SECTION

For this product

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

STORAGE AND HANDLING SECTION

  • store at room temperature

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

1-888-423-0139

TAMPER EVIDENT STATEMENT

OTHER SAFETY INFORMATION

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

ADVERSE REACTIONS

ADVERSE REACTIONS SECTION

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

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.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)

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
240698sodium fluoride 0.05 % (fluoride ion 0.02 % ) Oral RinsePSN3
240698sodium fluoride 0.5 MG/ML MouthwashSCD3
240698sodium fluoride 0.05 % (fluoride ion 0.02 % ) Oral RinseSY3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76162-838-38Anticavity fluoride rinse296 mL in 1 BOTTLE, PLASTICMOUTHWASH2963

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76162-83876162-838-38

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
SODIUM BENZOATEOJ245FE5EUIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
XYLITOLVCQ006KQ1EIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
SUCRALOSE96K6UQ3ZD4IACT
SODIUM CITRATE, UNSPECIFIED FORM1Q73Q2JULRIACT
SODIUM FLUORIDE8ZYQ1474W7ACTIM

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Anticavity fluoride rinseSODIUM FLUORIDETopco Associates LLCc3f2e952-a8d5-4e9d-a5c6-09e4f25441792026-02-13Warnings, Adverse reactionsExact identifier
ndc (package): 76162-838-38
ndc (product): 76162-838
ndc11 (package): 76162083838
spl id: 4ab9cdfd-2e94-8a3c-e063-6394a90ac07a
spl set id: c3f2e952-a8d5-4e9d-a5c6-09e4f2544179

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.