FDA.reportPublic FDA data

International Business Amenity Kit

Manufacturer
BUZZ PRODUCTS (HK) CO. LIMITED
Effective date
2021-11-15
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 22:27:52

Label at a glance#

ProductInternational Business Amenity Kit
Active ingredientSODIUM FLUORIDE
Label structure8 sections

Dosage and administration

adults and children 2 yrs. & older: brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist do not swallow to minimize swallowing use a pea-sized amount in children under 6 supervise children's brushing until good habits are established children under 2 yrs.: ask a dentist

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Sodium fluoride 0.243% (0.15% w/v fluoride ion)

Purpose

OTC - PURPOSE SECTION

Anticavity toothpaste

Use

INDICATIONS & USAGE SECTION

helps protect teeth and roots against cavities

Warnings

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 twice a day or use as directed by a dentist
  • do not swallow
  • to minimize swallowing use a pea-sized amount in children under 6
  • supervise children's brushing until good habits are established
  • children under 2 yrs.: ask a dentist

Inactive Ingredients

INACTIVE INGREDIENT SECTION

sorbitol, water, hydrated silica, sodium lauryl sulfate, trisodium phosphate, flavor, sodium phosphate, cellulose gum, carbomer 956, sodium saccharin, titanium dioxide, blue 1

Questions?

OTC - QUESTIONS SECTION

1-800-492-7378

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ToothpasteToothpaste

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70402-005-012021-11-15C16284748780-1ba0f9c33-231e-a910-e053-dadaa90a0b85International Business Amenity Kit
70402-005-012021-01-29C16284748780-1ba0f9c33-231e-a910-e053-dadaa90a0b85International Business Amenity Kit

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70402-00570402-005-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
SORBITOL506T60A25RIACT
WATER059QF0KO0RIACT
HYDRATED SILICAY6O7T4G8P9IACT
SODIUM LAURYL SULFATE368GB5141JIACT
SODIUM PHOSPHATESE337SVY37IACT
CARBOXYMETHYLCELLULOSE SODIUMK679OBS311IACT
SACCHARIN SODIUMSB8ZUX40TYIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
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
d0d99b5a-22ef-4b3b-e053-2995a90ad90bf1463f97-d4c4-4489-bb5c-752024d2f7ae2021-11-15WarningsExact identifier
spl id: d0d99b5a-22ef-4b3b-e053-2995a90ad90b
spl set id: f1463f97-d4c4-4489-bb5c-752024d2f7ae

Reported adverse events (FAERS/openFDA)#

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