ORAL B NEUTRACARE MINT MENTHE- sodium fluoride solution

Oral B NeutraCare by

Drug Labeling and Warnings

Oral B NeutraCare by is a Prescription medication manufactured, distributed, or labeled by YOUNG DENTAL MANUFACTURING CO 1, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

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

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

Inactive Ingredients
Ingredient Name	Strength
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

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

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

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