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

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Sodium Fluoride (UNII: 8ZYQ1474W7) (Fluoride ion - UNII:Q80VPU408O), Hydrofluoric Acid (UNII: RGL5YE86CZ) (Fluoride ion - UNII:Q80VPU408O)

Available from:

Laclede, Inc.

Administration route:

DENTAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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.

Authorization status:

unapproved drug other

Summary of Product characteristics

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._
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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
TOPICAL FLUORIDE FOAM BUMBLE BEE BUBBLE GUM
acidulated phosphate fluoride aerosol
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN PRESCRIPTION DRUG
ITE M CODE (SOURCE )
NDC:548 9 7-50 7
ROUTE OF ADMINISTRATION
DENTAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
SO DIUM FLUO RIDE (UNII: 8 ZYQ1474W7) (Fluo ride io n - UNII:Q8 0
VPU40 8 O)
Fluo ride io n
10 mg in 1 g
HYDRO FLUO RIC ACID (UNII: RGL5YE8 6 CZ) (Fluo ride io n - UNII:Q8 0
VPU40 8 O)
Fluo ride io n
2.3 mg in 1 g
PRODUCT CHARACTERISTICS
COLOR
S CORE
S HAP E
S IZ E
FLAVOR
BUBBLE GUM (Bubble Gum Flavo r)
IMPRINT CODE
CONTAINS
Laclede, Inc.
PACKAG ING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START DATE
MARKETING END DATE
1
NDC:548 9 7-50 7-17
16 5 g in 1 BOTTLE
MARKETING INFORMATION
MARKE TING CATE GORY
APPLICATION NUMBE R OR MONOGRAPH CITATION
MARKE TING START DATE
MARKE TING END DATE
unappro ved drug o ther
0 5/0 4/20 0 0
LABELER -
Laclede, Inc. (098835994)
Revised: 3/2011