Take Home Fluoride Cool Mint

TAKE HOME FLUORIDE COOL MINT- sodium fluoride gel, dentifrice
Patterson Dental Supply Inc

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.

INDICATIONS

Helps prevent dental caries and hypersensitivity.

ACTIVE INGREDIENT

Sodium Fluoride 1.1% (0.5% Fluoride Ion)

OTHER INGREDIENTS

Purified water, glycerin, Xylitol and other sweeteners. Contains FD&C Blue #1

DIRECTIONS

Adults and children six years of age and older should brush with PATTERSON BRAND TAKE HOME FLUORIDE 1.1% NEUTRAL SODIUM FLUORIDE GEL, once at bedtime.

  1. Apply thin bead of gel to toothbrush and brush for at least one minute making sure all tooth surfaces are covered.
  2. Adults: expectorate thoroughly. Do not rinse, eat, or drink for at least 30 minutes after use.
    Children 6 and older: expectorate and rinse thoroughly. If recommended by your dental professional, this product can be used in place of your regular toothpaste.

WARNINGS

DO NOT SWALLOW. Supervision is required while children are using this product in order to avoid ingestion. Swallowing excessive amounts of fluoride could cause dental fluorosis. KEEP OUT OF REACH OF INFANTS & CHILDREN.

PRECAUTIONS

For Professional Use only. Federal (USA) law prohibits dispensing without a prescription. Store at controlled room temperature 68° -77° F (20° — 25°C).

NDC# 5022710062

Manufactured in the USA

Questions? Call your dentist for more information.

Distributed by
Patterson Dental Supply, Inc.
1031 Mendota Heights Road
St. Paul, MN 55120

Reorder# 088-6093 12/Case

PRINCIPAL DISPLAY PANEL — 56 gm Tube Label

PATTERSON BRAND

Take Home Fluoride 1.1% Neutral Sodium Fluoride Gel

Cool Mint

Contains
Xylitol
Natural Sweetener

Net Wt. 2 Oz (56gm)

Principal Display Panel
(click image for full-size original)
TAKE HOME FLUORIDE COOL MINT
sodium fluoride gel, dentifrice
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50227-1006
Route of Administration DENTAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Sodium Fluoride (Fluoride Ion) Sodium Fluoride 5 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
Water
Anhydrous Citric Acid
Saccharin Sodium Dihydrate
Xylitol
Xanthan Gum
Glycerin
Product Characteristics
Color WHITE Score
Shape Size
Flavor MINT (Cool Mint) Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50227-1006-2 1 TUBE (TUBE) in 1 BOX, UNIT-DOSE contains a TUBE
1 56 g in 1 TUBE This package is contained within the BOX, UNIT-DOSE (50227-1006-2)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 04/15/1997
Labeler — Patterson Dental Supply Inc (171843584)

Revised: 04/2012 Patterson Dental Supply Inc

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