FLOAM TOPICAL FLOAM FLUORIDE- sodium fluoride aerosol, foam

Floam Topical Floam Fluoride by

Drug Labeling and Warnings

Floam Topical Floam Fluoride by is a Otc medication manufactured, distributed, or labeled by Germiphene Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Recommended use:

A topical anticaries preparation for professional dental use only.

PURPOSE

1.23% fluoride ion (from 1.69% sodium fluoride and 0.5% hydrogen fluoride) in a flavored base at pH 4.

Medicinal ingredients:

1.23% fluoride ion.

Non-medicinal ingredients:

Water, glycerin, cocamidopropyl betaine, xylitol, phosphoric acid, flavouring agents, xanthan gum, polysorbate 20, poloxamer 407, sodium saccharin, PVP, sodium benzoate

Directions:

1. Use after thorough prophylaxis. 2. Shake prior to dispensing. 3. Place nozzle tip to applicator floor and press down on trigger to dispense foam. NOTE: Foam will expand to fill tray. 4. Immediately place trays in mouth and have patient bite down lightly for one minute. 5. Remove trays and have patient expectorate excess.

Warning:

Do not eat, drink, or rinse for 30 minutes after treatment. Do not puncture or incinerate container or store at temperatures over 50°C. Do not use in presence of open flame or spark. Contents under pressure; do not place in hot water or near any sources of heat.

KEEP OUT OF REACH OF CHILDREN

Kep out of reach of children.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FLOAM TOPICAL FLOAM FLUORIDE 
sodium fluoride aerosol, foam

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61508-1120
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	1.732 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
HYDROFLUORIC ACID (UNII: RGL5YE86CZ)	1.039 g  in 100 g
GLYCERIN (UNII: PDC6A3C0OX)	14.96 g  in 100 g
POLYSORBATE 20 (UNII: 7T1F30V5YH)	0.609 g  in 100 g
XANTHAN GUM (UNII: TTV12P4NEE)	0.798 g  in 100 g
POLOXAMER 407 (UNII: TUF2IVW3M2)	2.991 g  in 100 g
SODIUM BENZOATE (UNII: OJ245FE5EU)	0.1 g  in 100 g
SACCHARIN SODIUM (UNII: SB8ZUX40TY)	0.199 g  in 100 g
XYLITOL (UNII: VCQ006KQ1E)	3.99 g  in 100 g
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)	4.985 g  in 100 g
POVIDONE (UNII: FZ989GH94E)	0.1 g  in 100 g
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)	2.493 g  in 100 g
WATER (UNII: 059QF0KO0R)	66.004 g  in 100 g

Product Characteristics
Color	white	Score
Shape		Size
Flavor	BERRY, MINT, ORANGE, STRAWBERRY, BUBBLE GUM, GRAPE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61508-1120-1	125 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/06/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		02/06/2017

Labeler - Germiphene Corporation (206412512)

Establishment
Name	Address	ID/FEI	Business Operations
Germiphene Corporation		206412512	manufacture(61508-1120)