TAKE HOME FLUORIDE COOL MINT- sodium fluoride gel, dentifrice

Take Home Fluoride by

Drug Labeling and Warnings

Take Home Fluoride by is a Prescription medication manufactured, distributed, or labeled by Patterson Dental Supply Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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).

SPL UNCLASSIFIED SECTION

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)

INGREDIENTS AND APPEARANCE

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Sodium Fluoride (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O)	Sodium Fluoride	5 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Anhydrous Citric Acid (UNII: XF417D3PSL)
Saccharin Sodium Dihydrate (UNII: SB8ZUX40TY)
Xylitol (UNII: VCQ006KQ1E)
Xanthan Gum (UNII: TTV12P4NEE)
Glycerin (UNII: PDC6A3C0OX)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor	MINT (Cool Mint)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50227-1006-2	1 in 1 BOX, UNIT-DOSE
1		56 g in 1 TUBE

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)