Package.Label Principal Display Panel

SPL PATIENT PACKAGE INSERT SECTION

DESCRIPTION SECTION

DESCRIPTION:Oral-B NeutraCare Home Topical Treatment is a mint flavored 1.1% w/w neutral sodium fluoride aqueous solution.

INACTIVE INGREDIENT SECTION

CLINICAL PHARMACOLOGY SECTION

INDICATIONS & USAGE SECTION

CONTRAINDICATIONS SECTION

WARNINGS SECTION

WARNINGS:

PRECAUTIONS SECTION

PREGNANCY SECTION

NURSING MOTHERS SECTION

PEDIATRIC USE SECTION

Pediatric use:  The use of fluoride solutions, gels, and foams containing up to 1.23 % fluoride ion as caries preventives in pediatric patients aged 6 to 16 years is supported by clinical studies in students aged 6 to 12 years (1,2). Safety and effectiveness in pediatric patients below the age of 6 years has not been established. Please refer to CONTRAINDICATIONS and WARNINGS sections.

GERIATRIC USE SECTION

ADVERSE REACTIONS SECTION

OVERDOSAGE SECTION

DOSAGE & ADMINISTRATION SECTION

DOSAGE AND ADMINISTRATION: Adults and Children 6 years and over:

HOW SUPPLIED SECTION

HOW SUPPLIED: NeutraCare is available in a plastic tube containing 2 FL OZ (60ml) in mint flavor, NDC 0041-241-22.

REFERENCES SECTION

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NeutraCare