Topical Fluoride Foam Bumble Bee Bubble Gum

Manufacturer
Laclede, Inc.
Effective date
2011-03-01
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
116
Source
legacy-cache
Hydrated at
2026-08-02 01:51:45

Label at a glance#

ProductTopical Fluoride Foam Bumble Bee Bubble Gum
Active ingredientSodium Fluoride, Hydrofluoric Acid
Label structure2 sections

Label contents#

Full prescribing information#

DESCRIPTION SECTION

Topical Fluoride Foam

Acidulated Phosphate Fluoride Solution Containing 1.23% w/w Fluoride ion

FOR PROFESSIONAL USE ONLY


Description: Topical Fluoride Foam is a flavored aqueous foaming solution of acidulated phosphate

sodium fluoride with pH of  3.5 and a fluoride ion concentration of 1.23% w/w.

Active Ingredients: Sodium Fluoride and Hydrofluoric Acid (equivalent to 1.23% w/w Fluoride ion).

Inactive Ingredients
: Purified Water, poloxamer 407, isobutane, poloxamer 234, phosphoric acid,
sodium saccharin, flavor.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Fluoride Foam

Image of LabelImage of Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
54897-507-172023-02-24C16284748780-1960f7f55-c4d9-8e05-e053-dbdaa90a074aPackage.Label Principal Display Panel
54897-507-172019-10-29C16284748780-1960f7f55-c4d9-8e05-e053-dbdaa90a074aPackage.Label Principal Display Panel

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Hydrofluoric AcidACTIVE INGREDIENTRGL5YE86CZ116
Sodium FluorideACTIVE INGREDIENT8ZYQ1474W7116
Fluoride ionACTIVE MOIETYQ80VPU408O116

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
54897-50754897-507-17

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
Sodium Fluoride8ZYQ1474W7ACTIM
Hydrofluoric AcidRGL5YE86CZACTIM

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
be0012a2-c6b8-40f2-9bd5-a8e945a7942f8cc75685-667b-4c51-9c61-9cd8081e7d812023-02-24Exact identifier
spl set id: 8cc75685-667b-4c51-9c61-9cd8081e7d81

Reported adverse events (FAERS/openFDA)#

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