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

----------

Package.Label Principal Display Panel

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

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:54897-507-17	165 g in 1 BOTTLE; Type 0: Not a Combination Product	05/04/2000	04/03/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		05/04/2000	04/03/2022

Labeler - Laclede, Inc. (098835994)

Registrant - Laclede, Inc. (098835994)

Name	Address	ID/FEI	Business Operations
Establishment
Laclede, Inc.		098835994	manufacture(54897-507)

Revised: 2/2023

Document Id: be0012a2-c6b8-40f2-9bd5-a8e945a7942f

Set id: 8cc75685-667b-4c51-9c61-9cd8081e7d81

Version: 117

Effective Time: 20230224

Laclede, Inc.