FDA.reportPublic FDA data

Anticavity Fluoride Rinse

Manufacturer
Geiss, Destin + Dunn, Inc | Vi-Jon
Effective date
2019-04-15
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-02 00:25:46

Label at a glance#

ProductAnticavity Fluoride Rinse
Active ingredientSODIUM FLUORIDE
Label structure7 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 the inside of cap); do not fill above the 10 mL mark vigorously swish 10 milliliters of rinse between 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 rins...

Storage and handling

store at room temperature

Label contents#

Full prescribing information#

Active ingredients

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 milliliters (10 mL mark on the inside of cap); do not fill above the 10 mL mark
  • vigorously swish 10 milliliters of rinse between 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 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, sorbitol, menthol, methyl salicylate, flavor, cetylpyridinium chloride, sodium saccharin, poloxamer 407, polysorbate 20, propylene glycol, sodium phosphate, disodium phosphate, calcium disodium EDTA, disodium EDTA, sodium benzoate, potassium sorbate, benzyl alcohol, green 3, yellow 5

principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Sealed With Printed Neckband For Your Protection

GOODSENSE

Anticavity

Fluoride

Rinse

Strong Cavity Protection

Alcohol Free

Mint

ADA

Accepted

American

Dental

Association

IMPORTANT:

Read Directions For Proper Use

Compare to active ingredient of ACT Anticavity Fluoride Rinse

18 FL OZ (532 mL)

image descriptionimage description

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50804-21350804-213-44

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM FLUORIDE8ZYQ1474W7ACTIM
water059QF0KO0RIACT
SORBITOL506T60A25RIACT
MENTHOLL7T10EIP3AIACT
METHYL SALICYLATELAV5U5022YIACT
CETYLPYRIDINIUM CHLORIDED9OM4SK49PIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
POLOXAMER 407TUF2IVW3M2IACT
POLYSORBATE 207T1F30V5YHIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SODIUM PHOSPHATESE337SVY37IACT
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FIACT
EDETATE CALCIUM DISODIUM ANHYDROUS8U5D034955IACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
SODIUM BENZOATEOJ245FE5EUIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
BENZYL ALCOHOLLKG8494WBHIACT
FD&C GREEN NO. 33P3ONR6O1SIACT
FD&C YELLOW NO. 5I753WB2F1MIACT

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
4bdbb4e2-16f8-42e3-b0e8-199040a850b6293581b3-4b43-4b36-929c-fb152f6cb25d2020-05-13WarningsExact identifier
spl set id: 293581b3-4b43-4b36-929c-fb152f6cb25d

Reported adverse events (FAERS/openFDA)#

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