NeutraGard Gel Mint

Manufacturer
Pascal Company, Inc.
Effective date
2019-01-30
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 20:27:40

Label at a glance#

ProductNeutraGard Gel Mint
Active ingredientSODIUM FLUORIDE
Label structure5 sections

Label contents#

Full prescribing information#

Dosage

DOSAGE FORMS & STRENGTHS SECTION

RX Only in USA

Before dispensing remove cap and peel off seal

Contains: 1.1% w/w Sodium fluoride (provides 5000ppm fluoride)

Usual treatment does contains 1-3 mg fluoride. A 2.0oz tube contains 300 mg of fluoride

Indications & Usage

INDICATIONS & USAGE SECTION

Indications and Usage

Aids in the prevention of dental cavities. This is an anti-cavity (preventive treatment gel, not a toothpaste. Read directions carefully before using. Clinical studies have shown that 1.1% sodium fluoride is safe and effective as an anti-cavity agent when used topically. This product should be applied with a toothbrush after brushing with a dentifrice toothpaste. It can be used in areas where drinking water is fluoridated since topical fluorides do not produce fluorosis when used as directed.

Adults and children 6 years of age and older: Use once daily after brushing with a dentifrice toothpaste. Apply a thin ribbon of gel to toothbrush and brush teeth thoroughly. Allow the gel to reamin on your teeth for 1 minute and then spit out. Do not swallow gel. For best effectiveness, do not eat or drink for 30 minutes after brushing. Supervise children less than 12 years of age as necessary when using this product to minimize swallowing.

Children under 6 years of age - consult a dentist or physician.

Contraindications

CONTRAINDICATIONS SECTION

Hypersensitivity to fluoride

Warnings & Precautions

WARNINGS AND PRECAUTIONS SECTION

Do not swallow.

Keep this and all drugs out of reach of children.

For use only under supervision of a dental professional or physician.

Adverse Reactions: Developing teeth of children under 6 years of age may become permanently discolored if excess quantities are repeatedly swallowed. Reactions of individuals whith fluoride hypersensitivity amy include: eczema, atopic dermatitis, uticaria, gastric distress, headache, and weakness.

Overdose: If you accidentally swallow more than used for brushing, administer calcium (e.g. milk) and seek professional medical assistance or contact local Poison Control Center immediately.

For product SDS information, please see company website at pascaldental.com or contact Pascal directly.

Neutragard Gel is free of gluten, milk, soy, egg, peanut and tree nut products.

Store product between 59-86ºF (15-30ºC)

NeutraGard Gel 1.1% Neutral Sodium Fluoride Gel Mint

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NeutraGard Gel Mint TubeNeutraGard Gel Mint TubepH7 5000

Preventive Treatment Gel for Home Use

Mint Flavor

REF 11-715

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1101877NeutraGard 1.1 % gel ToothpastePSN1
392038sodium fluoride 1.1 % ToothpastePSN1
1101877sodium fluoride 0.011 MG/MG Toothpaste [NeutraGard]SBD1
392038sodium fluoride 0.011 MG/MG ToothpasteSCD1
1101877NeutraGard 0.011 MG/MG ToothpasteSY1
1101877Neutragard 1.1 % Gel ToothpasteSY1
392038sodium fluoride 1.1 % (fluoride ion 0.5 % ) ToothpasteSY1
392038sodium fluoride 1.1 % Dental GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10866-0110-12021-01-29C16284748780-1ba0f9c33-255d-a910-e053-dadaa90a0b85NeutraGard Gel Mint

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10866-0110-1NeutraGard Gel Mint60 g in 1 TUBEGEL601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10866-0110NEUTRAGARD GEL MINT (TOPICAL NEUTRAL FLUORIDE GEL) GEL [PASCAL COMPANY, INC.]11 package rows20190131_80b3502e-1bce-1704-e053-2991aa0aaa5b.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10866-0110-1GM - Gram10866-0110b476730f-607a-4e30-8bd4-4aada9df8ba212019-02-13

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10866-011010866-0110-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM FLUORIDE8ZYQ1474W7ACTIM
WATER059QF0KO0RIACT

Source Document#

Source XML

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
80b3502e-1bcf-1704-e053-2991aa0aaa5b80b3502e-1bce-1704-e053-2991aa0aaa5b2019-01-30WarningsExact identifier
spl id: 80b3502e-1bcf-1704-e053-2991aa0aaa5b
spl set id: 80b3502e-1bce-1704-e053-2991aa0aaa5b

Reported adverse events (FAERS/openFDA)#

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