Prescription Drug Information: Topical Fluoride Foam Bumble Bee Bubble Gum

TOPICAL FLUORIDE FOAM BUMBLE BEE BUBBLE GUM — sodium fluoride and hydrofluoric acid aerosol
Laclede, Inc.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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.

Fluoride Foam

Image of Label
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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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Sodium Fluoride (Fluoride ion) Fluoride ion 10 mg in 1 g
Hydrofluoric Acid (Fluoride ion) 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 Multilevel Packaging
1 NDC:54897-507-17 165 g in 1 BOTTLE None
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)

Revised: 03/2011 Laclede, Inc.

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