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Acclean Anti-Cavity

Generic: SODIUM FLUORIDE

Verified·Apr 23, 2026
Manufacturer
Henry Schein
NDC
0404-0173
RxCUI
392038
Route
TOPICAL
ICD-10 indication
Z29.3

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About Acclean Anti-Cavity

What is this medication?

Acclean Anti-Cavity is a prescription-strength fluoride treatment, typically provided in the form of a toothpaste or gel, used to prevent dental decay and cavities. It contains a high concentration of sodium fluoride, which is significantly more potent than the amounts found in standard over-the-counter dental products. Dentists prescribe this medication to patients who are at an increased risk of developing dental caries due to factors such as high sugar intake, certain medical conditions, or difficulty maintaining optimal oral hygiene.

The medication works by promoting the remineralization of tooth enamel, which helps to repair early stages of tooth decay before a physical cavity forms. By strengthening the enamel, it makes the teeth more resistant to the acids produced by plaque and bacteria in the mouth. This treatment is often recommended for individuals with dry mouth, those wearing orthodontic appliances like braces, or patients with exposed tooth roots who require extra protection against sensitivity and decay.

Copay & patient assistance

Detailed copay and financial assistance information is not publicly available for this medication at this time. Please consult your pharmacist or the manufacturer's official patient support program for more details.

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Prescribing information

From the FDA-approved label for Acclean Anti-Cavity. Official source: DailyMed (NLM) · Label effective Nov 14, 2024

Indications and usage
1 INDICATIONS AND USAGE 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
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.
Contraindications
4 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.
Adverse reactions
6 ADVERSE REACTIONS Allergic reactions and other idiosyncrasies have rarely been reported.
Use in 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.

Label text is reproduced as-is from the FDA-approved label. We do not paraphrase, summarize, or omit. Content above is for informational purposes only and is not medical advice. Always consult your prescribing clinician or pharmacist before making decisions about your medication.

Conditions we've indexed resources for

Click a condition to see copay cards, grants, and PA rules specific to it. For the full list of FDA-approved indications, see Prescribing information above.

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How this page is sourced

  • Drug identity verified against openFDA NDC Directory.
  • Label text (when shown) originates from NLM DailyMed.
  • Copay and assistance URLs verified periodically; if you hit a broken link, tell us.