FDA.reportPublic FDA data

Kids Flouride Rinse

Manufacturer
WinCo Foods, LLC | Consumer Product Partners, LLC
Effective date
2025-03-20
Label type
HUMAN OTC DRUG LABEL
Version
14
Source
legacy-cache
Hydrated at
2026-08-01 20:40:19

Label at a glance#

ProductKids Flouride Rinse
Active ingredientSODIUM FLUORIDE
Label structure10 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 millilters (10 mL mark on inside of cap); do not fill above 10 mL mark vigourously 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 rinse

Use

INDICATIONS & USAGE SECTION

aids in the prevention of dental cavities

Warnings

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 millilters (10 mL mark on inside of cap); do not fill above 10 mL mark
  • vigourously 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

benzyl alcohol, calcium disodium EDTA, cetylpyridinium chloride, disodium EDTA, disodium phosphate, flavor, poloxamer 407, polysorbate 80, propylene glycol, red 33, sodium benzoate, sodium phosphate, sodium saccharin, sorbitol, water

Questions?

OTC - QUESTIONS SECTION

Call 800-824-1706 Monday - Friday 9am - 4pm MST

ADVERSE REACTION

ADVERSE REACTIONS SECTION

DISTRIBUTED BY: WINCO FOODS, LLC, BOISE, ID 83704

*This is not manufactured or distributed by Chattem, Inc., distributor of Act ®Anticavity Kids Fluoride Rinse.

The Supermarket Low Price Leader ®

100% SATISFACTION GUARANTEE

Comments & Questions?

800-824-1706

principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SEALED WITH PRINTED NECKAND FOR YOUR PROTECTION

*Compare to the active indredient in ACT ®Anticavity Kids Flouride Rinse

WinCo FOODS ®

ANTICAVITY 

Fluoride 

Rinse

Strong Cavity Protection

Alcohol Free

Helps Strengthen Teeth

ADA Accepted

American Dental Association

Helps prevent cavities

Bubble Gum Flavor

18 FL OZ (532 mL)

IMPORTANT READ DIRECTIONS FOR PROPER USE

image descriptionimage descriptionimage descriptionimage description

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67091-104KIDS FLOURIDE RINSE (SODIUM FLUORIDE) RINSE [WINCO FOODS, LLC]14Legacy NDC20250322_1cc5d6fb-d14a-49c2-90ac-d9626c55ac02.zip

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
67091-10467091-104-44

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZYL ALCOHOLLKG8494WBHIACT
EDETATE CALCIUM DISODIUM ANHYDROUS8U5D034955IACT
CETYLPYRIDINIUM CHLORIDED9OM4SK49PIACT
EDETATE DISODIUM7FLD91C86KIACT
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FIACT
POLOXAMER 407TUF2IVW3M2IACT
POLYSORBATE 806OZP39ZG8HIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
D&C RED NO. 339DBA0SBB0LIACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM PHOSPHATESE337SVY37IACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SORBITOL506T60A25RIACT
WATER059QF0KO0RIACT
SODIUM FLUORIDE8ZYQ1474W7ACTIM

Source Document#

Source XML · Source PDF

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
400abd8f-69f3-99db-e063-6394a90aa27f1cc5d6fb-d14a-49c2-90ac-d9626c55ac022025-09-30Warnings, Adverse reactionsExact identifier
spl set id: 1cc5d6fb-d14a-49c2-90ac-d9626c55ac02

Reported adverse events (FAERS/openFDA)#

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