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

Manufacturer: Patterson Dental Supply Inc
Effective date: 2012-04-26
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 20:15:09

Label at a glance#

ProductTake Home Fluoride Cool Mint

Active ingredientSodium Fluoride

Label structure7 sections

Dosage and administration

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. Apply thin bead of gel to toothbrush and brush for at least one minute making sure all tooth surfaces are covered. Adults: expectorate thoroughly. Do not rinse, eat, or drink for at least 30 minutes after use. Children 6 and older: expectorate and rinse thoroughly. ...

Label contents#

Full prescribing information#

INDICATIONS

INDICATIONS & USAGE SECTION

Helps prevent dental caries and hypersensitivity.

ACTIVE INGREDIENT

DESCRIPTION SECTION

Sodium Fluoride 1.1% (0.5% Fluoride Ion)

OTHER INGREDIENTS

SPL UNCLASSIFIED SECTION

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

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

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.

Apply thin bead of gel to toothbrush and brush for at least one minute making sure all tooth surfaces are covered.
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

WARNINGS SECTION

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

PRECAUTIONS SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PATTERSON BRAND

Take Home Fluoride
1.1% Neutral Sodium Fluoride Gel

Cool
Mint

Contains
Xylitol
Natural Sweetener

Net Wt. 2 Oz (56gm)

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
392038	sodium fluoride 1.1 % Toothpaste	PSN	1
392038	sodium fluoride 0.011 MG/MG Toothpaste	SCD	1
392038	sodium fluoride 1.1 % (fluoride ion 0.5 % ) Toothpaste	SY	1
392038	sodium fluoride 1.1 % Dental Gel	SY	1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
50227-1006-2	2020-01-31	C162847	48780-1	9d75b9d0-dc3c-f424-e053-dadaa90a57ce	Take Home Fluoride 1.1% Neutral Sodium Fluoride Gel- Cool Mint

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50227-1006-2	Take Home Fluoride Cool Mint	56 g in 1 TUBE	GEL, DENTIFRICE	56		1
50227-1006-2	Take Home Fluoride Cool Mint	1 in 1 BOX, UNIT-DOSE	GEL, DENTIFRICE	1		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50227-1006	TAKE HOME FLUORIDE COOL MINT (SODIUM FLUORIDE) GEL, DENTIFRICE [PATTERSON DENTAL SUPPLY INC]	1	Legacy NDC, 2 package rows	20120514_2bb36066-1c3a-40da-abb0-5cea28bd80f3.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Sodium Fluoride	ACTIVE INGREDIENT	8ZYQ1474W7	1
Fluoride Ion	ACTIVE MOIETY	Q80VPU408O	1
Anhydrous Citric Acid	INACTIVE INGREDIENT	XF417D3PSL	1
Glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	1
Saccharin Sodium Dihydrate	INACTIVE INGREDIENT	SB8ZUX40TY	1
Water	INACTIVE INGREDIENT	059QF0KO0R	1
Xanthan Gum	INACTIVE INGREDIENT	TTV12P4NEE	1
Xylitol	INACTIVE INGREDIENT	VCQ006KQ1E	1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 9 matching rows.

Take Home Fluoride Cool Mint
Sodium Fluoride
Fluoride Ion
Water
Anhydrous Citric Acid
Saccharin Sodium Dihydrate
Xylitol
Xanthan Gum
Glycerin

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
50227-1006	50227-1006-2

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
Sodium Fluoride	8ZYQ1474W7	ACTIB
Water	059QF0KO0R	IACT
Anhydrous Citric Acid	XF417D3PSL	IACT
Saccharin Sodium Dihydrate	SB8ZUX40TY	IACT
Xylitol	VCQ006KQ1E	IACT
Xanthan Gum	TTV12P4NEE	IACT
Glycerin	PDC6A3C0OX	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 4 · 211 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
Anhydrous Citric Acid	ANHYDROUS CITRIC ACID	XF417D3PSL	SUSPENSION / ORAL		400 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
Xylitol	XYLITOL	VCQ006KQ1E	PASTE / ORAL		180 mg	Exact identifier — unii candidate 12 equally ranked IID candidates
Saccharin Sodium Dihydrate	SACCHARIN SODIUM	SB8ZUX40TY	SYRUP / ORAL		24 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
Xanthan Gum	XANTHAN GUM	TTV12P4NEE	SOLUTION, GEL FORMING, EXTENDED RELEASE / OPHTHALMIC	0.6 %w/w		Exact identifier — unii candidate 29 equally ranked IID candidates
Anhydrous Citric Acid	ANHYDROUS CITRIC ACID	XF417D3PSL	AEROSOL, FOAM / TOPICAL		6 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	CLOTH / TOPICAL	0.05 mg/mg		Exact identifier — unii candidate 75 equally ranked IID candidates
Saccharin Sodium Dihydrate	SACCHARIN SODIUM	SB8ZUX40TY	PASTE, DENTIFRICE / DENTAL	0.2 %w/w		Exact identifier — unii candidate 34 equally ranked IID candidates
Saccharin Sodium Dihydrate	SACCHARIN SODIUM	SB8ZUX40TY	TABLET, ORALLY DISINTEGRATING / ORAL		10 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SOLUTION / OPHTHALMIC	6 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	LIQUID / TOPICAL	2.5 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
Anhydrous Citric Acid	ANHYDROUS CITRIC ACID	XF417D3PSL	CONCENTRATE / ORAL		84 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SOLUTION/ DROPS / OPHTHALMIC		12 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Saccharin Sodium Dihydrate	SACCHARIN SODIUM	SB8ZUX40TY	GEL / DENTAL	0.3 %w/w		Exact identifier — unii candidate 34 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	LIQUID / ORAL		2400 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	CAPSULE, EXTENDED RELEASE / ORAL		265 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Xylitol	XYLITOL	VCQ006KQ1E	SUSPENSION, EXTENDED RELEASE / ORAL		9000 mg	Exact identifier — unii candidate 12 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	GEL / TOPICAL		500 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Anhydrous Citric Acid	ANHYDROUS CITRIC ACID	XF417D3PSL	SOLUTION / ORAL		3900 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
Anhydrous Citric Acid	ANHYDROUS CITRIC ACID	XF417D3PSL	FILM, SOLUBLE / ORAL		7 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
Anhydrous Citric Acid	ANHYDROUS CITRIC ACID	XF417D3PSL	INJECTION, SOLUTION / INTRAVENOUS		772 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
Saccharin Sodium Dihydrate	SACCHARIN SODIUM	SB8ZUX40TY	INJECTION / INTRAMUSCULAR		22 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	TABLET, CHEWABLE / ORAL		12 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Anhydrous Citric Acid	ANHYDROUS CITRIC ACID	XF417D3PSL	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS		414 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
Anhydrous Citric Acid	ANHYDROUS CITRIC ACID	XF417D3PSL	TABLET / ORAL		197 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	JELLY / VAGINAL	NA		Exact identifier — unii candidate 75 equally ranked IID candidates
Xylitol	XYLITOL	VCQ006KQ1E	TABLET, EXTENDED RELEASE / ORAL		2752 mg	Exact identifier — unii candidate 12 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	CREAM, AUGMENTED / TOPICAL		55 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Xanthan Gum	XANTHAN GUM	TTV12P4NEE	TABLET, EXTENDED RELEASE / ORAL		528 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
Xanthan Gum	XANTHAN GUM	TTV12P4NEE	SUSPENSION / ORAL		360 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
Saccharin Sodium Dihydrate	SACCHARIN SODIUM	SB8ZUX40TY	FILM, SOLUBLE / BUCCAL		2 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SHAMPOO / TOPICAL	5 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
Saccharin Sodium Dihydrate	SACCHARIN SODIUM	SB8ZUX40TY	ELIXIR / ORAL	15 mg/5ml		Exact identifier — unii candidate 34 equally ranked IID candidates
Anhydrous Citric Acid	ANHYDROUS CITRIC ACID	XF417D3PSL	INJECTION / PERINEURAL	0.02 %w/v		Exact identifier — unii candidate 61 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SYSTEM / IONTOPHORESIS	168.1 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
Xanthan Gum	XANTHAN GUM	TTV12P4NEE	SUSPENSION, EXTENDED RELEASE / ORAL	186.8 mg		Exact identifier — unii candidate 29 equally ranked IID candidates
Anhydrous Citric Acid	ANHYDROUS CITRIC ACID	XF417D3PSL	SOLUTION / OPHTHALMIC	0.09 %w/v		Exact identifier — unii candidate 61 equally ranked IID candidates
Anhydrous Citric Acid	ANHYDROUS CITRIC ACID	XF417D3PSL	TABLET, CHEWABLE, EXTENDED RELEASE / ORAL		12 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
Xanthan Gum	XANTHAN GUM	TTV12P4NEE	POWDER, FOR SOLUTION / ORAL	10 mg/5ml		Exact identifier — unii candidate 29 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SUSPENSION/ DROPS / ORAL		750 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Saccharin Sodium Dihydrate	SACCHARIN SODIUM	SB8ZUX40TY	PASTE / ORAL		3 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	GUM, CHEWING / BUCCAL		230 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	INJECTION, SUSPENSION / SUBCUTANEOUS	1.6 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
Xanthan Gum	XANTHAN GUM	TTV12P4NEE	POWDER / ORAL	275 mg		Exact identifier — unii candidate 29 equally ranked IID candidates
Anhydrous Citric Acid	ANHYDROUS CITRIC ACID	XF417D3PSL	INJECTION / INFILTRATION	0.02 %w/v		Exact identifier — unii candidate 61 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	FILM, EXTENDED RELEASE / TRANSDERMAL	306.2 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	PASTE / ORAL		3822 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Anhydrous Citric Acid	ANHYDROUS CITRIC ACID	XF417D3PSL	SHAMPOO / TOPICAL	0.07 %w/w		Exact identifier — unii candidate 61 equally ranked IID candidates
Anhydrous Citric Acid	ANHYDROUS CITRIC ACID	XF417D3PSL	PASTE / ORAL		26 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
Xanthan Gum	XANTHAN GUM	TTV12P4NEE	ENEMA / RECTAL		150 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
Anhydrous Citric Acid	ANHYDROUS CITRIC ACID	XF417D3PSL	SUSPENSION/ DROPS / ORAL		15 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
Xylitol	XYLITOL	VCQ006KQ1E	FILM, SOLUBLE / ORAL		29 mg	Exact identifier — unii candidate 12 equally ranked IID candidates
Xanthan Gum	XANTHAN GUM	TTV12P4NEE	SOLUTION / ORAL		84 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
Anhydrous Citric Acid	ANHYDROUS CITRIC ACID	XF417D3PSL	SPRAY, METERED / NASAL	1.2 mg/1ml		Exact identifier — unii candidate 61 equally ranked IID candidates
Anhydrous Citric Acid	ANHYDROUS CITRIC ACID	XF417D3PSL	SUSPENSION/ DROPS / OPHTHALMIC	0.05 %w/v		Exact identifier — unii candidate 61 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	TABLET, EXTENDED RELEASE / ORAL		7 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	TABLET, COATED / ORAL	1 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SUSPENSION / OPHTHALMIC		58 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Xylitol	XYLITOL	VCQ006KQ1E	SOLUTION / ORAL		21600 mg	Exact identifier — unii candidate 12 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	DROPS / ORAL	300 mg/1ml		Exact identifier — unii candidate 75 equally ranked IID candidates
Saccharin Sodium Dihydrate	SACCHARIN SODIUM	SB8ZUX40TY	TABLET / RECTAL	0.6 mg		Exact identifier — unii candidate 34 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
e706de58-1350-47c2-83d2-0b8562ac5953			2bb36066-1c3a-40da-abb0-5cea28bd80f3	2012-04-26	Warnings	Exact identifier spl id: e706de58-1350-47c2-83d2-0b8562ac5953 spl set id: 2bb36066-1c3a-40da-abb0-5cea28bd80f3

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.