Sodium Fluoride

Manufacturer
Vi-Jon
Effective date
2020-10-05
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 23:10:32

Label at a glance#

ProductSodium Fluoride
Active ingredientSODIUM FLUORIDE
Label structure9 sections

Dosage and administration

Adults and children 6 years of age and older: use twice daily after brushing your teeth with a toothpaste vigorously swish 10 mL (2 teaspoonfuls) of rinse between your teeth for 1 miute 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 u...

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Sodium fluoride 0.02% (0.01% 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, get medical help or contact a Poison Control Center immediately

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 6 years of age and older:

  • use twice daily after brushing your teeth with a toothpaste
  • vigorously swish 10 mL (2 teaspoonfuls) of rinse between your teeth for 1 miute 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

OTHER SAFETY INFORMATION

  • store at room temperature 20⁰-25⁰ C (68⁰-77⁰ F)
  • cold weather may temporarily cloud this product

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, sorbitol solution, propylene glycol, flavor, sodium lauryl sulfate, poloxamer 407, sodium benzoate, phosphoric acid, sodium saccharin, disodium phosphate, sucralose, red 40, blue 1

principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Anticavity Mouthwash

IMPORTANT: Read directions for proper use.

33.8 FL OZ (1 L)

971.000/971AA

image descriptionimage description

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0869-0971-862024-12-18C16284748780-1d6a99b39-b211-a426-e053-dadaa90af4c2971.001 971AB Fluoride Anti-Cavity Mouthwash
0869-0971-862022-01-28C16284748780-1d6a99b39-b211-a426-e053-dadaa90af4c2971.001 971AB Fluoride Anti-Cavity Mouthwash

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0869-09710869-0971-86

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

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
298fbd4a-9ea0-99ec-e063-6394a90a1cdb25b10a42-e66d-4ef1-92e5-0d2261bdb4822024-12-18WarningsExact identifier
spl set id: 25b10a42-e66d-4ef1-92e5-0d2261bdb482

Reported adverse events (FAERS/openFDA)#

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