The following Structured Product Label (SPL) was submitted to the FDA by Rising Pharma Holdings, Inc. for the product Denta 5000 Plus Sensitive (NDC 16571-823). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, description:, active ingredients:, inactive ingredients:, clinical pharmacology:, indications and usage:, contraindications:, warnings:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
DENTA 5000 PLUS SENSITIVE BRAND OF 1.1% SODIUM FLUORIDE, 5% POTASSIUM NITRATE PRESCRIPTION STRENGTH TOOTHPASTE FOR SENSITIVE TEETH
Rx Only
Distributed by:
Rising Pharma Holdings, Inc.
East Brunswick, NJ 08816
Manufactured by:
Lyne Laboratories, Inc.
Brockton, MA 02301
Issued: 09/23
Self-topical neutral fluoride toothpaste containing 1.1% (w/w) sodium fluoride and 5% potassium nitrate.
Potassium Nitrate 5%, Sodium Fluoride 1.1% (w/w)
Sorbitol, Hydrated Silica, PEG 600, Sodium Carboxymethylcellulose, Flavor, Sodium Lauryl Sulfate, Sodium Benzoate, Sucralose, Titanium Dioxide, Sodium Hydroxide, FD&C Blue #1, D&C Yellow #10, Purified Water.
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.
A dental caries preventive and sensitive teeth toothpaste; for twice daily self-applied topical use, followed by rinsing. Helps reduce the painful sensitivity of the teeth to cold, heat, acids, sweets or contact in adult patients and children 12 years of age and older. It is well established that 1.1% sodium fluoride is safe and extraordinarily effective as a caries preventive when applied frequently with mouthpiece applicators.1-4 Denta 5000 Plus Sensitive 1.1% sodium fluoride toothpaste with 5% potassium nitrate in a squeeze tube is easily applied onto a toothbrush. This prescription toothpaste should be used twice daily in place of your regular toothpaste unless otherwise instructed by your dental professional. May be used in areas where drinking water is fluoridated since topical fluoride cannot produce fluorosis. (See WARNINGS for exception.)
Do not use in pediatric patients under age 12 years unless recommended by a dentist or physician.
Not for systemic treatment - DO NOT SWALLOW. Keep out of reach of infants and children. Children under 12 years of age, consult a dentist or physician.
Note: 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.
Not for systemic treatment. DO NOT SWALLOW.
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 weight) did not result in impaired fertility and reproductive capabilities.
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.
Safety and effectiveness in pediatric patients below the age of 12 years have not been established. Please refer to the CONTRAINDICATIONS and WARNINGS sections.
Of the total number of subjects in clinical studies of 1.1% (w/v) sodium fluoride, 15 percent were 65 and over, while 1 percent were 75 and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, 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 patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care
should be taken in dose selection, and it may be useful to monitor renal function.
Allergic reactions and other idiosyncrasies have been rarely reported. To report SUSPECTED ADVERSE REACTIONS, contact Rising Pharma Holdings, Inc. at 1-844-874-7464 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
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 body weight (i.e., more than 6.9 mg fluoride/lb body weight), induce vomiting and admit immediately to a hospital facility.
A treatment dose (a thin ribbon) of Denta 5000 Plus Sensitive contains approximately 2.5 mg fluoride. A 3.4 FL OZ (100 mL) tube contains 575 mg fluoride.
Follow these instructions unless otherwise instructed by your dental professional:
Store at Controlled Room Temperature, 68-77°F (20-25°C).
Rising Pharma Holdings, Inc. NDC 16571-823-10
Denta 5000 Plus Sensitive
1.1% Sodium Fluoride, 5% Potassium Nitrate
Prescription Strength Toothpaste For Sensitive Teeth
Mild Mint
3.4 fl. OZ. (100 mL) Rx only
Dentaplussen-cont-label (Dentaplussen Cont Label)
Dentaplussen-carton-label (Dentaplussen Carton Label)
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