Kit 2

Manufacturer
Buzz Export Services Pty., Ltd.
Effective date
2023-12-21
Label type
HUMAN OTC DRUG LABEL
Version
10
Source
full-release
Hydrated at
2026-06-01 00:54:43

Label at a glance#

ProductKit 2
Active ingredientSODIUM FLUORIDE
Label structure7 sections

Dosage and administration

adults and children 2 yrs. & older: brush teeth thoroughly after meals or at least tweice a day or use as directed by a dentist  do not swallow to minimize swallowing use a pea-sized amount in children under 6  children under 2 yrs: ask a dentist

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Sodium fluoride 0.243% (0.16% w/v fluoride ion)

Purpose

OTC - PURPOSE SECTION

Anticavity toothpaste

Use

INDICATIONS & USAGE SECTION

helps protect against cavities

Warning

WARNINGS SECTION

Keep out of reach of children 

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

under 6 yrs. of age. if more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • adults and children 2 yrs. & older: brush teeth thoroughly after meals or at least tweice a day or use as directed by a dentist 
  • do not swallow
  • to minimize swallowing use a pea-sized amount in children under 6 
  • children under 2 yrs: ask a dentist

Inactive ingredients

INACTIVE INGREDIENT SECTION

glycerin, hydrated silica, sodium hexametaphosphate, water, flavor, trisodium phosphate, sodium lauryl sulfate, carrageenan, cocamidopropyl betaine sodium saccharin, PEG-20M or PEG-23M, Xanthan gum, sucralose, mica, titanium dioxide

Questions?

OTC - QUESTIONS SECTION

1-800-492-7378

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabelKitKit

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69491-080KIT 2 (SODIUM FLUORIDE) KIT [BUZZ EXPORT SERVICES PTY., LTD.]10Legacy NDC20250210_4705d0bc-a1a4-26db-e054-00144ff8d46c.zip
69491-081KIT 2 (SODIUM FLUORIDE) KIT [BUZZ EXPORT SERVICES PTY., LTD.]10Unmatched20250210_4705d0bc-a1a4-26db-e054-00144ff8d46c.zip

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69491-08069491-080-00
69491-08169491-081-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 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
4d26d108-8ad7-f220-e063-6394a90ae0674705d0bc-a1a4-26db-e054-00144ff8d46c2026-03-16WarningsExact identifier
spl set id: 4705d0bc-a1a4-26db-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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