Acclean Anti-Cavity
Sodium Fluoride · Paste, Dentifrice · Topical
Uses
Acclean Prescription Strength Anti-Cavity Toothpaste is indicated for use as part of a professional program for the prevention and control of dental caries.
Dosage and 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 Acclean Prescription Strength Anti-Cavity 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.
Dosage forms and strengths
Acclean Prescription Strength Anti-Cavity Toothpaste Mint: Green containing 1.1% Sodium Fluoride (Mint). ( 3 )
Contraindications
Do not use in children under 6 years of age unless recommended by a dentist or physician.
Warnings and precautions
5 WARNINGS AND 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.
Side effects
Allergic reactions and other idiosyncrasies have rarely been reported.
Use in specific populations
8.1 Pregnancy Pregnancy Category B It has been shown that fluoride crosses the placenta of rats, but only 0.01% of the amount administered is incorporated in fetal tissues. Animal studies (rats, mice, rabbits) have shown that fluoride is not a teratogen. Maternal exposure to 12.2 mg fluoride/kg of body weight (rats) or 13.1 mg/kg of body weight (rabbits) did not affect the litter size or fetal weight and did not increase the frequency of skeletal or visceral malformations. There are no adequate or well controlled clinical studies in pregnant women. However, epidemiological studies conducted in areas with high levels of naturally fluoridated water showed no increase in birth defects. Heavy exposure to fluoride during in utero development may result in skeletal fluorosis which becomes evident in childhood. 8.3 Nursing Mothers It is not known if fluoride is excreted in human milk. However, many drugs are excreted in milk, and caution should be exercised when products containing fluoride are administered to a nursing woman. Reduced milk production was reported in farm-raised fox when the animals were fed a diet containing a high concentration of fluoride (98-137 mg/kg of body weight). No adverse effects on parturition, lactation, or offspring were seen in rats administered fluoride up to 5 mg/kg of body weight. 8.4 Pediatric Use The use of Acclean Prescription Strength Anti-Cavity Toothpaste in children age 6-16 as a caries preventive is supported by pioneering clinical studies with 1.1% sodium fluoride gels in mouth trays in students age 11-14 years conducted by Englander, et al. 2-4 Safety and effectiveness in pediatric patients below the age of 6 years have not been established. Prescribing physicians and dentists should consider total fluoride exposure (dental care plus food, water, and other sources) when prescribing the product for use in children. Please refer to the CONTRAINDICATIONS and WARNINGS AND PRECAUTIONS sections. 8.5 Geriatric Use Subjects referenced in clinical studies of 1.1% (w/v) sodium fluoride, included 15 percent age 65 and over, with 1 percent age 75 and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger clients, but greater sensitivity of some older individuals cannot be ruled out. This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in clients with impaired renal function. Because elderly clients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.
Pregnancy
8.1 Pregnancy Pregnancy Category B It has been shown that fluoride crosses the placenta of rats, but only 0.01% of the amount administered is incorporated in fetal tissues. Animal studies (rats, mice, rabbits) have shown that fluoride is not a teratogen. Maternal exposure to 12.2 mg fluoride/kg of body weight (rats) or 13.1 mg/kg of body weight (rabbits) did not affect the litter size or fetal weight and did not increase the frequency of skeletal or visceral malformations. There are no adequate or well controlled clinical studies in pregnant women. However, epidemiological studies conducted in areas with high levels of naturally fluoridated water showed no increase in birth defects. Heavy exposure to fluoride during in utero development may result in skeletal fluorosis which becomes evident in childhood.
Pediatric use
8.4 Pediatric Use The use of Acclean Prescription Strength Anti-Cavity Toothpaste in children age 6-16 as a caries preventive is supported by pioneering clinical studies with 1.1% sodium fluoride gels in mouth trays in students age 11-14 years conducted by Englander, et al. 2-4 Safety and effectiveness in pediatric patients below the age of 6 years have not been established. Prescribing physicians and dentists should consider total fluoride exposure (dental care plus food, water, and other sources) when prescribing the product for use in children. Please refer to the CONTRAINDICATIONS and WARNINGS AND PRECAUTIONS sections.
Geriatric use
8.5 Geriatric Use Subjects referenced in clinical studies of 1.1% (w/v) sodium fluoride, included 15 percent age 65 and over, with 1 percent age 75 and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger clients, but greater sensitivity of some older individuals cannot be ruled out. This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in clients with impaired renal function. Because elderly clients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.
Overdosage
Accidental ingestion of large amounts of fluoride may result in acute burning in the mouth and sore tongue. Nausea, vomiting, and diarrhea may occur soon after ingestion (within 30 minutes) and are accompanied by salivation, hematemesis, and epigastric cramping abdominal pain. These symptoms may persist for 24 hours. If less than 5 mg fluoride/kg body weight (i.e., less than 2.3 mg fluoride/lb body weight) have been ingested, give calcium (e.g., milk) orally to relieve gastrointestinal symptoms and observe for a few hours. If more than 5 mg fluoride/kg body weight (i.e., more than 2.3 mg fluoride/lb body weight) have been ingested, induce vomiting, give orally soluble calcium (e.g., milk, 5% calcium gluconate or calcium lactate solution) and immediately seek medical assistance. For accidental ingestion of more than 15 mg fluoride/kg of body weight (i.e., more than 6.9 mg fluoride/lb body weight), induce vomiting and admit immediately to a hospital facility.
Description
Acclean Prescription Strength Anti-Cavity Toothpaste is a self-applied topical fluoride dentifrice containing 1.1% (w/w) sodium fluoride for the prevention and control of dental caries. Acclean Prescription Strength Anti-Cavity Toothpaste with Mint Flavor: 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, Silica, Sodium Laurel Sulfate, Sodium Saccharin, Sorbitol, Water, Xylitol.
How supplied
4 oz. (113.4g) net wt. tube Acclean Prescription Strength Anti-Cavity Toothpaste NDC 0404 0173 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 753548120 R:0 01/24SN
Label text from the FDA structured product label by Henry Schein, Inc. (revised Nov 14, 2024). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Sodium Fluoride in 1 product
Acclean Anti-Cavity NDC products (1)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 0404-0173 | Sodium Fluoride 1.1 g/100g Paste, Dentifrice | Henry Schein, Inc. | UNAPPROVED DRUG OTHER |
Frequently asked questions
What is Acclean Anti-Cavity used for?
Acclean Prescription Strength Anti-Cavity Toothpaste is indicated for use as part of a professional program for the prevention and control of dental caries.
What are the side effects of Acclean Anti-Cavity?
Allergic reactions and other idiosyncrasies have rarely been reported. See the full label for the complete list.
Who makes Acclean Anti-Cavity?
Acclean Anti-Cavity is listed by 1 labeler in the FDA NDC directory, including Henry Schein, Inc..