Label: NEUTRAGARD GEL MINT- topical neutral fluoride gel gel
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Contains inactivated NDC Code(s)
NDC Code(s): 10866-0110-1 - Packager: Pascal Company, Inc.
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Export only
Drug Label Information
Updated January 30, 2019
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- Dosage
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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
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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
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INGREDIENTS AND APPEARANCE
NEUTRAGARD GEL MINT
topical neutral fluoride gel gelProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10866-0110 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 11.28 mg in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) 942 mg in 1 g Product Characteristics Color green Score Shape Size Flavor MINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10866-0110-1 60 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(10866-0110)
pH7 5000