ORAL B NEUTRACARE 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 NeutraCare

Inactives

Purified water, carboxymethylcellulose sodium, spearmint oil, sucralose, phosphoric acid,sodium hydroxide.

Indication and Usage

A once daily topical neutral aqueous solution for the prevention of dental caries.

After brushing with dentifrice, apply a thin ribbon of the formulation to teeth for at least1 minute using a toothbrush.Expectorate and do not eat, drink or rinse for at least 30 minutes.

Warnings

DO NOT SWALLOW. Keep outof reach of children.If more than used for treatment isswallowed, administer calcium(e.g. milk) and get medical help orcontact a Poison Control Centerright away. For professional use only.

Package Label

Product Label

ORAL B NEUTRACARE MINT MENTHE
sodium fluoride solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:0273-0241
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)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
SPEARMINT OIL (UNII: C3M81465G5)
SUCRALOSE (UNII: 96K6UQ3ZD4)
PHOSPHORIC ACID (UNII: E4GA8884NN)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Product Characteristics
Color		Score
Shape		Size
Flavor	SPEARMINT	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0273-0241-22	57 g in 1 TUBE; Type 0: Not a Combination Product	11/23/2014

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		11/23/2014

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