Drug Facts
Composition & Profile
Identifiers & Packaging
16 HOW SUPPLIED/STORAGE AND HANDLING 4 oz. (113.4g) net wt. tube Acclean Prescription Strength Anti-Cavity Toothpaste for Sensitivity Relief NDC 0404 0174 04 Store at controlled room temperature 15°-30° C (59°-86° F) Rx Only Distributed by: Henry Schein Inc. 135 Duryea Road Melville, NY 11747 USA 753212700 R:0 01/24SN; Principal Display Panel – 113.4 g Carton Label ACCLEAN™ PRESCRIPTION STRENGTH ANTI-CAVITY TOOTHPASTE 1.1 % Sodium Fluoride 5000 PPM 5% Potassium Nitrate For Sensitivity Relief, Mint NET WT: 4 FL OZ (113.4g) by HENRY SCHEIN® Principal Display Panel – 113.4 g Carton Label
- 16 HOW SUPPLIED/STORAGE AND HANDLING 4 oz. (113.4g) net wt. tube Acclean Prescription Strength Anti-Cavity Toothpaste for Sensitivity Relief NDC 0404 0174 04 Store at controlled room temperature 15°-30° C (59°-86° F) Rx Only Distributed by: Henry Schein Inc. 135 Duryea Road Melville, NY 11747 USA 753212700 R:0 01/24SN
- Principal Display Panel – 113.4 g Carton Label ACCLEAN™ PRESCRIPTION STRENGTH ANTI-CAVITY TOOTHPASTE 1.1 % Sodium Fluoride 5000 PPM 5% Potassium Nitrate For Sensitivity Relief, Mint NET WT: 4 FL OZ (113.4g) by HENRY SCHEIN® Principal Display Panel – 113.4 g Carton Label
Overview
Acclean Prescription Strength Anti-Cavity Toothpaste for Sensitivity Relief is a self-applied topical fluoride dentifrice containing 1.1% (w/w) sodium fluoride for the prevention and control of dental caries, and 5% (w/w) P otassium Nitrate for relief of tooth sensitivity. Sensitivity Relief: 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, PEG/PPG-116/66 Copolymer, Potassium Nitrate, Silica, Sodium Lauryl Sulfate, Sodium Saccharin, Sorbitol, Water, Xylitol.
Indications & Usage
Acclean Prescription Strength Anti-Cavity Toothpaste for Sensitivity Relief 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 12 or older, apply a thin ribbon or pea-sized amount of Acclean Prescription Strength Anti-Cavity Toothpaste for Sensitivity Relief 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 12 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 12 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 12 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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