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Oral-B Neutracare

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.

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 LABEL Item Code (Source) NDC:0273-0241
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Sodium Fluoride (FLUORIDE ION) FLUORIDE ION 0.5 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
Water
CARBOXYMETHYLCELLULOSE SODIUM
spearmint oil
sucralose
phosphoric acid
SODIUM HYDROXIDE
Product Characteristics
Color Score
Shape Size
Flavor SPEARMINT Imprint Code
Contains
Packaging
# Item Code Package Description
1 NDC:0273-0241-22 57 g in 1 TUBE
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)
Establishment
Name Address ID/FEI Operations
Medical Products Laboratories, Inc 002290302 manufacture(0273-0241)
YOUNG DENTAL MANUFACTURING CO 1, LLC