Label: ACCLEAN ANTI-CAVITY- sodium fluoride paste, dentifrice
- NDC Code(s): 0404-0173-04
- Packager: Henry Schein, Inc.
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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Drug Label Information
Updated November 14, 2024
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HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use Acclean Prescription Strength Anti-Cavity Toothpaste safely and effectively. See full prescribing information.
Acclean Prescription Strength Anti-Cavity Toothpaste with 1.1% Sodium Fluoride for oral useINDICATIONS AND USAGE
Acclean Prescription Strength Anti-Cavity Toothpaste is indicated for use as part of a professional program for prevention and control of dental caries. (1)
DOSAGE AND ADMINISTRATION
- 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. (2)
- After use, adults should expectorate. For best results, do not eat, drink, or rinse for 30 minutes. Children, age 6-16, should expectorate after use and rinse mouth thoroughly. (2)
- Use twice daily as your normal dentifrice or as directed by your dental professional. (2)
DOSAGE FORMS AND STRENGTHS
Acclean Prescription Strength Anti-Cavity Toothpaste with Mint Flavor: 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. (4)
WARNINGS AND PRECAUTIONS
- DO NOT SWALLOW. (5)
- 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. (5)
- Repeated ingestion of high levels of fluoride may cause dental fluorosis. (5)
- Do not use this product longer than 4 weeks unless recommended by a dentist or physician. (5)
ADVERSE REACTIONS
Allergic reactions and other idiosyncrasies have rarely been reported. (6)
To report SUSPECTED ADVERSE REACTIONS, contact your Henry Schein Dental representative.
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FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
6 ADVERSE REACTIONS
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.3 Nursing Mothers
8.4 Pediatric Use
8.5 Geriatric Use
10 OVERDOSAGE
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
15 REFERENCES
16 HOW SUPPLIED/STORAGE AND HANDLING
* Sections or subsections omitted from the full prescribing information are not listed. - 1 INDICATIONS AND USAGE
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2 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.
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3 DOSAGE FORMS AND STRENGTHS
Acclean Prescription Strength Anti-Cavity Toothpaste Mint: Green containing 1.1% Sodium Fluoride (Mint). (3)
- 4 CONTRAINDICATIONS
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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.
- 6 ADVERSE REACTIONS
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8 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.
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10 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.
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11 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.
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12 CLINICAL PHARMACOLOGY
A treatment dose (a thin ribbon) of Acclean Prescription Strength Anti-Cavity Toothpaste 5000 ppm sodium fluoride toothpaste contains 2.5 mg fluoride. A 4 oz. tube contains 566 mg fluoride.
Frequent topical applications to the teeth with preparations having a relatively high fluoride content increase tooth resistance to acid dissolution and enhance penetration of the fluoride ion into tooth enamel.
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13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
In a study conducted in rodents, no carcinogenesis was found in male and female mice and female rats treated with fluoride at dose levels ranging from 4.1 to 9.1 mg/kg of body weight. Equivocal evidence of carcinogenesis was reported in male rats treated with 2.5 and 4.1 mg/kg of body weight. In a second study, no carcinogenesis was observed in rats, males or females, treated with fluoride up to 11.3 mg/kg of body weight. Epidemiological data provide no credible evidence for an association between fluoride, either naturally occurring or added to drinking water, and risk of human cancer. Fluoride ion is not mutagenic in standard bacterial systems. It has been shown that fluoride ion has potential to induce chromosome aberrations in cultured human and rodent cells at doses much higher than those to which humans are exposed. In vivo data are conflicting. Some studies report chromosome damage in rodents, while other studies using similar protocols report negative results. Potential adverse reproductive effects of fluoride exposure in humans have not been adequately evaluated. Adverse effects on reproduction were reported for rats, mice, fox, and cattle exposed to 100 ppm or greater concentrations of fluoride in their diet or drinking water. Other studies conducted in rats demonstrated that lower concentrations of fluoride (5 mg/kg of body w eight) did not result in impaired fertility and reproductive capabilities.
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15 REFERENCES
- American Dental Association, Council on Dental Therapeutics, Fluoride compounds, In: Accepted Dental Therapeutics, Ed. 40, Chicago, ADA, 405-407, (1984).
- Englander HR, et al., Clinical Anticaries Effect of Repeated Topical Sodium Fluroide Applications by Mouthpieces, JADA, 75, 638-644, (1967).
- Englander HR, et al., Residual Anticaries Effect of Repeated Topical Sodium Fluoride Applications by Mouthpieces, JADA, 78, 783-787 (1969).
- Englander HR, et al: JADA, 83:354-358, 1971.
- 16 HOW SUPPLIED/STORAGE AND HANDLING
- Principal Display Panel – 113.4 g Carton Label
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INGREDIENTS AND APPEARANCE
ACCLEAN ANTI-CAVITY
sodium fluoride paste, dentifriceProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0404-0173 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 1.1 g in 100 g Inactive Ingredients Ingredient Name Strength CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Glycerin (UNII: PDC6A3C0OX) Mica (UNII: V8A1AW0880) Titanium Dioxide (UNII: 15FIX9V2JP) PEG/PPG-116/66 COPOLYMER (UNII: JP0CK963E0) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) Sodium Lauryl Sulfate (UNII: 368GB5141J) Saccharin Sodium (UNII: SB8ZUX40TY) Sorbitol (UNII: 506T60A25R) Water (UNII: 059QF0KO0R) Xylitol (UNII: VCQ006KQ1E) Product Characteristics Color Score Shape Size Flavor MINT (MINT) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0404-0173-04 1 in 1 CARTON 01/28/2025 1 113.4 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 01/28/2025 Labeler - Henry Schein, Inc. (012430880) Registrant - Den-Mat Holdings, LLC (809857704) Establishment Name Address ID/FEI Business Operations Den-Mat Holdings, LLC 809857704 MANUFACTURE(0404-0173)
