NEUTRAGARD GEL STRAWBERRY- topical neutral fluoride gel gel

NeutraGard Gel Strawberry by

Drug Labeling and Warnings

NeutraGard Gel Strawberry by is a Prescription medication manufactured, distributed, or labeled by Pascal Company, Inc., Pascal Company, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Dose:

Contains:

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

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

Indications & Directions:

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

pH7 5000

Preventive Treatment Gel for Home Use

Tropical Blast Flavor

REF 11-718

Before dispensing remove cap and peel off seal

INGREDIENTS AND APPEARANCE

NEUTRAGARD GEL STRAWBERRY 
topical neutral fluoride gel gel

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 10866-0117
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	7 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
EDETATE CALCIUM DISODIUM (UNII: 25IH6R4SGF)	1 mg  in 1 g
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)	0.1 mg  in 1 g
SACCHARIN SODIUM (UNII: SB8ZUX40TY)	2.5 mg  in 1 g
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)	18.5 mg  in 1 g

Product Characteristics
Color	red	Score
Shape		Size
Flavor	STRAWBERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10866-0117-1	56.7 g in 1 TUBE; Type 0: Not a Combination Product	07/01/1999

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Export only		07/01/1999

Labeler - Pascal Company, Inc. (009260217)

Establishment
Name	Address	ID/FEI	Business Operations
Pascal Company, Inc		009260217	manufacture(10866-0117)