TOPICAL FLUORIDE FOAM BUMBLE BEE BUBBLE GUM- acidulated phosphate fluoride aerosol

Topical Fluoride Foam Bumble Bee Bubble Gum by

Drug Labeling and Warnings

Topical Fluoride Foam Bumble Bee Bubble Gum by is a Prescription medication manufactured, distributed, or labeled by Laclede, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DESCRIPTION

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.

PRINCIPAL DISPLAY PANEL

Fluoride Foam

INGREDIENTS AND APPEARANCE

TOPICAL FLUORIDE FOAM BUMBLE BEE BUBBLE GUM 
acidulated phosphate fluoride aerosol

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 54897-507
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Sodium Fluoride (UNII: 8ZYQ1474W7) (Fluoride ion - UNII:Q80VPU408O)	Fluoride ion	10 mg  in 1 g
Hydrofluoric Acid (UNII: RGL5YE86CZ) (Fluoride ion - UNII:Q80VPU408O)	Fluoride ion	2.3 mg  in 1 g

Product Characteristics
Color		Score
Shape		Size
Flavor	BUBBLE GUM (Bubble Gum Flavor)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54897-507-17	165 g in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		05/04/2000

Labeler - Laclede, Inc. (098835994)