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Sea Salt Anticavity Salt47

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This product has been discontinued

Active ingredient
Sodium Fluoride 0.0024 g/1 g
Other brand names
Dosage form
Paste, Dentifrice
Route
Dental
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2018
Label revision date
August 30, 2019
Active ingredient
Sodium Fluoride 0.0024 g/1 g
Other brand names
Dosage form
Paste, Dentifrice
Route
Dental
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2018
Label revision date
August 30, 2019
Manufacturer
Toms of Maine, Inc.
Registration number
part355
NDC root
51009-901

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Drug Overview

Tom's of Maine is a natural anticavity toothpaste designed to help maintain your oral health. It contains fluoride, which is known to protect against cavities, and includes purified sea salt to enhance its effectiveness. This toothpaste not only helps strengthen your enamel but also gently scrubs away surface stains and fights germs that cause bad breath, leaving your mouth feeling fresh.

Available in a 4.7 oz (133 g) tube, Tom's of Maine has been a trusted choice since 1970, offering a refreshing mint flavor that makes brushing your teeth a pleasant experience.

Uses

You can use this product to help protect your teeth against cavities. Cavities are areas of decay that can develop in your teeth, leading to discomfort and more serious dental issues if not treated. This product is designed to support your dental health by reducing the risk of these problems.

It's important to note that there are no known teratogenic effects (harmful effects on a developing fetus) or nonteratogenic effects associated with this product, making it a safe option for most users.

Dosage and Administration

To keep your teeth healthy, it's important to brush thoroughly, ideally after each meal or at least twice a day. This applies to both adults and children aged 2 years and older. If you're helping a child between 2 and 6 years old, use only a pea-sized amount of toothpaste and supervise them while they brush and rinse to prevent swallowing any toothpaste.

For children under 2 years old, it's best to consult with a dentist or physician before starting any brushing routine. They can provide guidance tailored to your child's needs. Remember, good dental hygiene is essential for everyone!

What to Avoid

It's important to ensure that you use this product safely. Keep it out of reach of children under 6 years old to prevent any accidental ingestion. If a child accidentally swallows more than what is typically used for brushing, seek medical help immediately or call the Poison Control Center at (412) 390-3381.

There are no specific contraindications, controlled substance classifications, or noted risks of abuse, misuse, or dependence associated with this product. However, always follow the usage instructions carefully to ensure your safety and well-being.

Side Effects

It's important to keep this product out of reach of children under 6 years old. If a child accidentally swallows more than what is used for brushing, seek medical help immediately or call the Poison Control Center at (412) 390-3381.

Always use this product as directed to minimize any risks associated with accidental ingestion. Your safety is a priority, so please take these precautions seriously.

Warnings and Precautions

It's important to keep this product out of reach of children under 6 years of age to prevent accidental ingestion. If a child accidentally swallows more than what is typically used for brushing, seek medical help immediately or call the Poison Control Center at (412) 390-3381.

Always use this product as directed and be cautious about the amount used. If you have any concerns or experience unusual symptoms, stop using the product and contact your doctor for further advice. Your safety is a priority, so don’t hesitate to reach out for help if needed.

Overdose

If you accidentally swallow more than the amount used for brushing your teeth, it’s important to seek medical help immediately. You can call the Poison Control Center at (412) 390-3381 for guidance.

Signs of an overdose may not always be obvious, so it's best to err on the side of caution. If you suspect an overdose, don’t hesitate to reach out for help. Your safety is the priority, and prompt action can make a difference.

Pregnancy Use

There is currently no specific information available regarding the use of Sea Salt Anticavity Toothpaste during pregnancy. This means that the drug insert does not provide details on safety concerns, dosage adjustments, or any special precautions you should take while pregnant.

If you are pregnant or planning to become pregnant, it’s always a good idea to consult with your healthcare provider before using any new products, including toothpaste, to ensure they are safe for you and your baby.

Lactation Use

If you are breastfeeding or planning to breastfeed, you can feel reassured that there are no specific warnings or recommendations regarding nursing mothers or lactation in the information provided. This means that, based on the available data, there are no known risks associated with breastfeeding while using this medication. However, it's always a good idea to consult with your healthcare provider about any concerns you may have regarding your health and breastfeeding.

Pediatric Use

It's important to keep this product out of reach of children under 6 years old. If a child accidentally swallows more than what is needed for brushing, seek medical help immediately or call the Poison Control Center at (412) 390-3381.

For children aged 2 years and older, you should help them brush their teeth thoroughly, ideally after each meal or at least twice a day, unless directed otherwise by a dentist or physician. For children between 2 and 6 years old, use only a pea-sized amount of the product and supervise their brushing and rinsing to reduce the risk of swallowing. If your child is under 2 years old, consult a dentist or physician before use.

Geriatric Use

When it comes to using this medication in older adults, there is no specific information available about dosage adjustments, safety concerns, or special precautions. This means that if you or a loved one is an older adult considering this medication, it’s important to consult with a healthcare provider. They can help determine the best approach based on individual health needs and any other medications being taken. Always prioritize open communication with your healthcare team to ensure safe and effective treatment.

Renal Impairment

If you have kidney problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or safety considerations related to renal impairment (kidney issues). This means that there are no tailored recommendations for how your treatment may need to change based on your kidney function.

Always consult your healthcare provider for personalized advice and to ensure that your treatment plan is safe and effective for your specific situation. They can help monitor your kidney health and make any necessary adjustments to your medications.

Hepatic Impairment

If you have liver problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or precautions for your condition. This means that there are no tailored guidelines for how this medication may affect you differently due to your liver health.

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your situation. They can help monitor your liver function and make any necessary adjustments to your treatment plan.

Drug Interactions

It's great to know that there are no known interactions between this medication and other drugs or laboratory tests. However, it's still very important to discuss all medications you are taking, including over-the-counter drugs and supplements, with your healthcare provider. This ensures that your treatment is safe and effective.

Always keep your healthcare provider informed about any changes in your health or new medications you may start. Open communication helps prevent any potential issues and supports your overall well-being.

Storage and Handling

To ensure the best performance of your product, store it at room temperature and avoid freezing it. When not in use, make sure to keep the tube tightly closed to prevent contamination. If you notice any signs of contamination after opening, please discard the product immediately to maintain safety. Following these guidelines will help you use the product effectively and safely.

Additional Information

You should use this product for dental care by brushing your teeth thoroughly, ideally after each meal or at least twice a day, unless your dentist or physician advises otherwise. For children aged 2 to 6 years, use only a pea-sized amount and supervise their brushing and rinsing to help prevent swallowing. If your child is under 2 years old, consult a dentist or physician for guidance.

FAQ

What is Tom's of Maine?

Tom's of Maine is a natural anticavity toothpaste that contains fluoride and purified sea salt, available in a 4.7 OZ (133 g) tube.

How does Tom's of Maine help with dental health?

It helps protect against cavities, gently scrubs away surface stains, fights bad breath germs, and strengthens enamel.

What is the recommended usage for adults and children over 2 years?

Brush your teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician.

What should children aged 2 to 6 do when using Tom's of Maine?

Children aged 2 to 6 should use only a pea-sized amount and should be supervised while brushing and rinsing to minimize swallowing.

What should I do if a child under 6 accidentally swallows more than the recommended amount?

If more than used for brushing is accidentally swallowed, get medical help or call the Poison Control Center at (412) 390-3381 right away.

Are there any contraindications for using Tom's of Maine?

No contraindications are listed for Tom's of Maine.

Is Tom's of Maine safe for use during pregnancy or lactation?

There are no specific warnings or recommendations regarding use during pregnancy or lactation provided in the text.

How should Tom's of Maine be stored?

Store at room temperature, do not freeze, and keep the tube tightly closed when not in use.

Packaging Info

Below are the non-prescription pack sizes of Sea Salt Anticavity Salt47 (sodium fluoride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Sea Salt Anticavity Salt47.
Details

Drug Information (PDF)

This file contains official product information for Sea Salt Anticavity Salt47, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

Tom's® OF MAINE anticavity toothpaste is a natural formulation that contains fluoride and purified sea salt. This product, introduced in 1970, is designed to gently scrub away surface stains while effectively fighting bad breath germs. It also contributes to the strengthening of enamel. The toothpaste is presented in a 4.7 oz (133 g) tube and features a refreshing mint flavor.

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 recommended 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 and potential harm.

In the event that more than the recommended amount used for brushing is accidentally swallowed, immediate medical assistance should be sought. Healthcare professionals are advised to contact the Poison Control Center at (412) 390-3381 for guidance and support in managing the situation effectively.

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.

While specific adverse reactions were not detailed in the provided information, the emphasis on safety precautions highlights the importance of proper usage to mitigate potential risks.

Drug Interactions

No drug interactions or drug and laboratory test interactions have been identified for this product. Therefore, no specific recommendations for dosage adjustments or monitoring are necessary.

Packaging & NDC

Below are the non-prescription pack sizes of Sea Salt Anticavity Salt47 (sodium fluoride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Sea Salt Anticavity Salt47.
Details

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 years and older, it is recommended to brush teeth thoroughly, preferably after each meal or at least twice daily, or as directed by a dentist or physician. Children aged 2 to 6 years should use only a pea-sized amount of the product and require supervision during brushing and rinsing to minimize the risk of swallowing. For infants and children under 2 years of age, consultation with a dentist or physician is advised prior to use.

Geriatric Use

There is no specific information 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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

There is no specific information regarding the use of Sea Salt Anticavity Toothpaste during pregnancy. The prescribing information does not provide safety concerns, dosage modifications, or special precautions for pregnant patients. Therefore, healthcare professionals should exercise clinical judgment when recommending this product to women of childbearing potential. It is advisable to consider the overall oral health needs of pregnant patients while being mindful of the lack of data on potential fetal impacts associated with this product.

Lactation

There are no specific warnings or recommendations regarding nursing mothers or lactation in the provided text. Therefore, healthcare professionals should consider the absence of data when advising lactating mothers about the use of this medication. It is advisable to monitor breastfed infants for any potential effects, although no specific information is available.

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 relation to the use of this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions outlined 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 prudent in these cases, although specific parameters are not defined in the available information.

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 symptoms associated with overdosage effectively. It is recommended that healthcare providers remain vigilant for any adverse reactions and be prepared to implement appropriate management procedures based on the clinical presentation of the patient.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

No postmarketing experience details are available in the provided data.

Patient Counseling

Healthcare providers should advise patients 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, 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 that must be kept tightly closed when not in use to maintain its integrity. It should be stored at room temperature, ensuring that it is not exposed to freezing conditions. In the event that the product becomes contaminated after opening, it should be discarded to ensure safety and efficacy.

Additional Clinical Information

The product is administered via the dental route. For adults and children aged 2 years and older, it is recommended to brush 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, only a pea-sized amount should be used, and adult supervision is advised during 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.

No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Sea Salt Anticavity Salt47, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Data Generation & Sources

This page was automatically generated and is maintained by the AllDrugs AI Data-Science Team. It was built from the FDA Structured Product Label (DailyMed) for Sea Salt Anticavity Salt47, retrieved by a validated AI data-extraction workflow.

All FDA-listed dosage forms and strengths are shown in the Packaging & NDC Codes section above. Regulatory status appears in the Summary Information panel above and was verified in the FDA National Drug Code directory and the NSDE NDC Directory daily file.

Note: an automated daemon monitors NSDE checksums; when the record for this NDC changes, the new file is pulled instantly and this page is refreshed.

No human clinician has reviewed this version.

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Primary FDA sources:

Orange Book data shown on this page are limited to Regulatory Status (Rx), Established Pharmacologic Class (EPC), and Mechanism of Action (MoA).

Regulatory data notice: Information on this page is reproduced verbatim from FDA public databases (NSDE, Orange Book, Purple Book, DailyMed SPL). NDA/ANDA drugs are FDA-approved, BLA biologics are FDA-licensed. Inclusion alone does not guarantee current market availability or imply FDA endorsement.

Medical disclaimer: This AI-generated content is provided for educational purposes only and does not constitute medical advice. Always consult a licensed healthcare professional for diagnosis or treatment decisions.