Drug Facts
Composition & Profile
Identifiers & Packaging
16 HOW SUPPLIED/STORAGE AND HANDLING 4 oz. (112 g) net wt. tube • Daily Defense Fruit NDC 59883-015-04 Store at controlled room temperature 15°-30° C (59°-86° F) Rx Only Manufactured for Den-Mat Holding, LLC ©2016 Den-Mat Holdings, LLC 1017 W. Central Ave. All rights reserved Lompoc, CA 93436 reserved752260000 11/16SN; Principal Display Panel FLUORIDEX NDC 59883-016-04 DAILY DEFENSE Prescription-Strength Anticavity Toothpaste CLEAN MINT 1.1% Sodium Fluoride 5000PPM Net Wt. 4 oz. (112 g) Rx Only clean_mint
- 16 HOW SUPPLIED/STORAGE AND HANDLING 4 oz. (112 g) net wt. tube • Daily Defense Fruit NDC 59883-015-04 Store at controlled room temperature 15°-30° C (59°-86° F) Rx Only Manufactured for Den-Mat Holding, LLC ©2016 Den-Mat Holdings, LLC 1017 W. Central Ave. All rights reserved Lompoc, CA 93436 reserved752260000 11/16SN
- Principal Display Panel FLUORIDEX NDC 59883-016-04 DAILY DEFENSE Prescription-Strength Anticavity Toothpaste CLEAN MINT 1.1% Sodium Fluoride 5000PPM Net Wt. 4 oz. (112 g) Rx Only clean_mint
Overview
Fluoridex toothpaste is a self-applied topical fluoride dentifrice containing 1.1% (w/w) sodium fluoride for the prevention and control of dental caries. Daily Defense Mint: Each gram contains 5 mg of fluoride ion in a neutral pH base, consisting of Cellulose Gum, D&C Yellow No. 10, FD&C Blue No. 1, Flavor, Glycerin, Mica (and) Titanium Dioxide, Poloxamer 234, Silica, Sodium Laurel Sulfate, Sodium Saccharin, Sorbitol, Water, Xylitol. Daily Defense Fruit: Each gram contains 5 mg of fluoride ion in a neutral pH base, consisting of Cellulose Gum, D&C Red No. 33, Flavor, Glycerin, Mica (and) Titanium Dioxide, Poloxamer 234, Silica, Sodium Laurel Sulfate, Sodium Saccharin, Sorbitol, Water, Xylitol. Enhanced Whitening Mint: Each gram contains 5 mg of fluoride ion in a neutral pH base, consisting of Cellulose Gum, D&C Yellow No. 10, FD&C Blue No. 1, Flavor, Glycerin, Mica (and) Titanium Dioxide, Poloxamer 234, Silica, Sodium Laurel Sulfate, Sodium Saccharin, Sorbitol, Water, Xylitol.
Indications & Usage
Fluoridex toothpaste is indicated for use as part of a professional program for the prevention and control of dental caries.
Dosage & Administration
Follow these instructions or use as instructed by a dental professional.• Adults and children age 6 or older, apply a thin ribbon or pea-sized amount of Fluoridex toothpaste to a toothbrush and brush thoroughly on all tooth surfaces for at least one minute. After use: • Adults should expectorate. For best results, do not eat, drink, or rinse for 30 minutes. • Children, age 6 to 16, should expectorate after use and rinse mouth thoroughly. • Use twice daily as your normal dentifrice or as directed by your dental professional.
Warnings & Precautions
DO NOT SWALLOW. • Keep out of reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away. • Prolonged daily ingestion may result in various degrees of dental fluorosis in children with developing dentition, especially if the water fluoridation exceeds 0.6 ppm, since younger children frequently cannot perform the brushing process without significant swallowing. • Use in children under age 6 years requires special supervision to prevent repeated swallowing of toothpaste which could cause dental fluorosis. • Read directions carefully before using. • Keep out of reach of infants and children. • Sensitive teeth may indicate a serious problem that may need prompt care by a dentist. • See your dentist if the problem persists or worsens. Do not use this product longer than 4 weeks unless recommended by a dentist or physician.
Contraindications
Do not use in children under 6 years of age unless recommended by a dentist or physician.
Adverse Reactions
Allergic reactions and other idiosyncrasies have rarely been reported.
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