Toms of Maine Deep Clean Spearmint

Description

Tom's of Maine anticavity toothpaste is a naturally derived formulation designed for oral care. This product features a spearmint flavor and contains fluoride to aid in cavity prevention. The toothpaste is equipped with micro-polishers that effectively remove up to 95% of surface stains, contributing to a whiter appearance. It is presented in a net weight of 4.0 oz (113 g) and is free from animal testing, sodium lauryl sulfate (SLS), peroxide, and artificial flavors or dyes.

Uses and Indications

This drug is indicated for the protection against dental cavities.

There are no teratogenic effects associated with this drug, and no nonteratogenic effects have been reported.

Dosage and Administration

Adults and children aged 2 years and older are advised to brush their teeth thoroughly, preferably after each meal or at least twice daily, or as directed by a dentist or physician.

For children aged 2 to 6 years, it is recommended to use only a pea-sized amount of the product. Caregivers should supervise the child's brushing and rinsing to minimize the risk of swallowing.

For children under 2 years of age, consultation with a dentist or physician is necessary prior to use.

Contraindications

Use is contraindicated in children under 6 years of age. Due to the potential risk of accidental ingestion, if more than the recommended amount for brushing is swallowed, seek medical assistance immediately or contact the Poison Control Center at (412) 390-3381.

Warnings and Precautions

It is imperative to keep this product out of the reach of children under 6 years of age to prevent accidental ingestion. In the event that more than the recommended amount used for brushing is accidentally swallowed, immediate medical assistance should be sought. Healthcare professionals should advise caregivers to contact the Poison Control Center at (412) 390-3381 without delay.

These precautions are essential to ensure the safe use of the product and to mitigate any potential risks associated with accidental ingestion.

Side Effects

Patients should be aware of the following warnings associated with the use of this product. It is crucial to keep the product out of reach of children under 6 years of age to prevent accidental ingestion. In the event that more than the recommended amount used for brushing is accidentally swallowed, it is imperative to seek medical assistance immediately or contact the Poison Control Center at (412) 390-3381.

These precautions are essential to ensure the safety and well-being of patients, particularly young children who may be more susceptible to adverse effects from improper use.

Drug Interactions

There are no specific drug interactions or laboratory test interactions identified in the available data. Therefore, no recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Toms of Maine Deep Clean Spearmint (sodium fluoride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 6 years of age should be kept out of reach of this product. In the event that more than the recommended amount for brushing is accidentally swallowed, immediate medical assistance should be sought by contacting the Poison Control Center at (412) 390-3381.

For children aged 2 to 6 years, it is advised to use only a pea-sized amount of the product. Caregivers should supervise the child's brushing and rinsing to minimize the risk of swallowing. For children under 2 years, consultation with a dentist or physician is recommended prior to use.

Geriatric Use

There is no specific information available regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy.

Pregnancy

There is no specific information regarding the use of this medication during pregnancy, including safety concerns, dosage modifications, or special precautions. Healthcare professionals should consider the lack of data when prescribing this medication to pregnant patients. The potential risks and benefits should be carefully evaluated, and alternative treatments may be considered in the absence of established safety profiles. Women of childbearing potential should be counseled on the importance of effective contraception during treatment.

Lactation

Lactating mothers should consult a healthcare professional before using this product. There is a potential for excretion in breast milk; therefore, caution is advised when administering to nursing mothers.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in clinical trials for this medication. Consequently, there is no available information regarding dosage adjustments, special monitoring requirements, or precautions for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be warranted based on clinical judgment.

Overdosage

In the event of an overdosage, immediate medical assistance is crucial. If an individual accidentally swallows more than the amount typically used for brushing, it is imperative to seek medical help without delay. Healthcare professionals should advise contacting the Poison Control Center at (412) 390-3381 for further guidance.

Prompt intervention is essential to manage potential complications associated with overdosage. Symptoms may vary depending on the substance involved, and healthcare providers should be prepared to assess and address any adverse effects that may arise. It is recommended that medical personnel follow established protocols for the management of overdosage cases, ensuring that appropriate measures are taken to mitigate risks and provide supportive care as needed.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data limits the assessment of potential risks associated with the compound in these areas.

Postmarketing Experience

No postmarketing experience details are available for SPL code 90375-7.

Patient Counseling

Healthcare providers should advise patients to keep the product out of reach of children under 6 years of age to prevent accidental ingestion.

In the event that more than the recommended amount used for brushing is accidentally swallowed, patients should be instructed to seek medical help immediately or contact the Poison Control Center at (412) 390-3381. It is important for patients to understand the potential risks associated with improper use of the product and to act promptly in case of an emergency.

Storage and Handling

The product is supplied in a tube format, with specific handling and storage requirements to ensure its integrity and effectiveness. It should be stored at room temperature, avoiding exposure to freezing conditions. To maintain the quality of the product, the tube must be kept tightly closed when not in use. Additionally, it is recommended to discard the product after opening if it is not used within a specified time frame, although this duration is not detailed in the provided information.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Toms of Maine Deep Clean Spearmint, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)