MS APF
ccbde522-645f-42f2-952b-d047b91e7b17
HUMAN PRESCRIPTION DRUG LABEL
Jan 27, 2022
M&S Dental Supply Co., LLC
DUNS: 173747767
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Sodium Fluoride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (11)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
INDICATIONS & USAGE SECTION
Indications and Usage:
- A stable thixotropic fluoride treatment gel used to help prevent dental decay.
- For Professional Use Only. This product is not intended for home or unsupervised use.
SPL UNCLASSIFIED SECTION
Active Ingredient:
Fluoride Ion 1.23%..............................................Flouride Treatment Gel
Available from 2.09% Sodium Fluoride and Hydrofluoric Acid
WARNINGS SECTION
Warnings:
- Keep out of reach of children.
- Do not swallow. If product is accidentally swallowed in quantities greater than would normally occur with a treatment gel, seek medical help or contact a Poison Control Center right away.
- Read directions carefully before using.
DOSAGE & ADMINISTRATION SECTION
Dosage and Administration:
Shake well before use. This is a one minute or four minute fluoride gel for in-office patient use. It is normally used as a preventative caries treatment two times a year.
1. After thorough prophylaxsis, fill two single or one dual tray, one third full with gel. Air dry teeth and insert trays into the mouth.
2. Instruct patient to bite down lightly but firmly for one minute (80% effectiveness) or four minutes (100% effectiveness).
3. Remove trays. Instruct patient to expectorate any excess gel and not to eat or drink for at least 30 minutes.
OTHER SAFETY INFORMATION
Other Information:
Store at controlled room temperature 59° to 86°F (15°-30°C).
Protect from freezing.
INACTIVE INGREDIENT SECTION
Inactive Ingredients:
Citric Acid, Flavor, Magnesium Aluminum Silicate, Phosphoric Acid, Polysorbate 20, Sodium Benzoate, Sodium Saccharin, Titanium Dioxide, Water, Xanthan Gum, Xylitol. May contain blue #1, green #3, red #3, red #40, yellow #5(tartrazine), yellow #6 as a color additive.