NEUTRAGARD GEL MINT- topical neutral fluoride gel gel 
Pascal Company, Inc.

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NeutraGard Gel Mint

Dosage

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 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

Hypersensitivity to fluoride

Warnings & Precautions

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

NeutraGard Gel Mint TubepH7 5000

Preventive Treatment Gel for Home Use

Mint Flavor

REF 11-715

NEUTRAGARD GEL MINT 
topical neutral fluoride gel gel
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:10866-0110
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION11.28 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R) 942 mg  in 1 g
Product Characteristics
ColorgreenScore    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10866-0110-160 g in 1 TUBE; Type 0: Not a Combination Product07/01/1999
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Export only07/01/1999
Labeler - Pascal Company, Inc. (009260217)
Establishment
NameAddressID/FEIBusiness Operations
Pascal Company, Inc.009260217manufacture(10866-0110)

Revised: 1/2019
Document Id: 80b3502e-1bcf-1704-e053-2991aa0aaa5b
Set id: 80b3502e-1bce-1704-e053-2991aa0aaa5b
Version: 1
Effective Time: 20190130
 
Pascal Company, Inc.