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.

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Take Home Fluoride 1.1% Neutral Sodium Fluoride Gel- Cool Mint

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
TAKE HOME FLUORIDE   COOL MINT
sodium fluoride gel, dentifrice
Product Information
Product TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:50227-1006
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sodium Fluoride (Fluoride Ion) Sodium Fluoride5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
Water 
Anhydrous Citric Acid 
Saccharin Sodium Dihydrate 
Xylitol 
Xanthan Gum 
Glycerin 
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorMINT (Cool Mint) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50227-1006-21 in 1 BOX, UNIT-DOSE
156 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER04/15/1997
Labeler - Patterson Dental Supply Inc (171843584)

Revised: 4/2012
Document Id: e706de58-1350-47c2-83d2-0b8562ac5953
Set id: 2bb36066-1c3a-40da-abb0-5cea28bd80f3
Version: 1
Effective Time: 20120426
 
Patterson Dental Supply Inc