ORAL B NEUTRA FOAM MINT MENTHE- sodium fluoride solution
YOUNG DENTAL MANUFACTURING CO 1, LLC

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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Oral B Neutra Foam

Descrption

Oral-B Neutra-Foam ® is a mint flavored neutral aqueous foaming solution of 2.0% w/w sodium fluoride.

Inactives

Purified water,poloxamer 407, cocamidoprophylbetaine, xylitol, sucralose, flavors.

Indication and Usage

A topically applied foaming solution to aid in the prevention of dental caries.

Warnings

In theevent more than the treatment dose isswallowed, administer calcium (e.g.milk) and get medical help or contact aPoison Control Center right away. Avoidspraying towards open flame. Contentsunder pressure. Do not puncture orincinerate. Do not expose to heat. Storeat temperatures between 59-86°F(15-30°C). Keep from freezing.

Package Label

Product Label

ORAL B NEUTRA FOAM MINT MENTHE
sodium fluoride solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:0273-0348
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.5 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
POLOXAMER 407 (UNII: TUF2IVW3M2)
XYLITOL (UNII: VCQ006KQ1E)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Product Characteristics
Color		Score
Shape		Size
Flavor	SPEARMINT	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0273-0348-06	165 g in 1 TUBE; Type 0: Not a Combination Product	10/08/2015

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		10/08/2015

Labeler - YOUNG DENTAL MANUFACTURING CO 1, LLC (006309355)