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Ocean Friends Anticavity Fluoride Bubblegum Flavor

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Active ingredient
Sodium Fluoride 0.243 g/100 g
Other brand names
Dosage form
Paste, Dentifrice
Route
Dental
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2024
Label revision date
October 17, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Sodium Fluoride 0.243 g/100 g
Other brand names
Dosage form
Paste, Dentifrice
Route
Dental
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2024
Label revision date
October 17, 2024
Manufacturer
CVS Pharmacy, Inc.
Registration number
M021
NDC root
51316-163
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

If you are a consumer or patient please visit this version.

Drug Overview

This medication is designed to help protect your teeth against cavities, which are small holes that can form in your teeth due to decay. By using this drug, you can support your dental health and reduce the risk of developing cavities, contributing to a healthier smile.

Uses

You can use this product to help protect your teeth against cavities. It works by strengthening your enamel and creating a barrier that helps prevent decay. This is especially important for maintaining good oral health and keeping your smile bright.

Rest assured, there are no known teratogenic effects (which means it doesn't cause birth defects) or nonteratogenic effects associated with this product. This makes it a safe choice for most users.

Dosage and Administration

To keep your teeth healthy, it's important to brush thoroughly after meals or at least twice a day. If you're an adult or a child aged 2 years and older, make sure to follow these guidelines or any specific instructions given by your dentist. Remember, do not swallow the toothpaste.

For children aged 2 to 6 years, use only a pea-sized amount of toothpaste to help minimize the risk of swallowing. It's also essential to supervise their brushing and rinsing until they develop good habits. If your child is under 2 years old, it's best to consult with a dentist or doctor before using any toothpaste.

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 you or someone else accidentally swallows more than the amount intended for brushing, seek professional help or contact a Poison Control Center right away. This will help ensure everyone's 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 the amount used for brushing, you should seek professional help or contact a Poison Control Center right away.

Always use this product as directed to minimize any risks. If you have any concerns about its use, please consult with a healthcare professional.

Warnings and Precautions

It's important to keep this product out of reach of children under 6 years old to prevent accidental ingestion. If you or someone else accidentally swallows more than what is needed for brushing, seek professional help or contact a Poison Control Center immediately.

While there are no specific general precautions or laboratory tests mentioned, always use this product as directed. If you experience any unusual symptoms or have concerns, it's best to consult your doctor for guidance.

Overdose

If you accidentally swallow more of the medication than what is typically used for brushing, it’s important to act quickly. You should seek professional help or contact a Poison Control Center right away.

Signs of an overdose can vary, but it’s crucial to be aware of any unusual symptoms you may experience. If you notice anything concerning, don’t hesitate to reach out for assistance. Remember, it’s always better to be safe and get help if you think you may have taken too much.

Pregnancy Use

When it comes to using Ocean Friends Anticavity Fluoride Toothpaste during pregnancy, there is no specific information available regarding its safety, dosage adjustments, or any special precautions you should take. This means that the manufacturer has not provided guidance on how this toothpaste may affect you or your baby during pregnancy.

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

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to talk to your healthcare professional before using this product. There is a possibility that the ingredients could be passed into your breast milk, so caution is recommended.

The effects on your nursing infant have not been thoroughly studied, which means you should carefully weigh the potential risks against the benefits of using this product. Your healthcare provider can help you make an informed decision that is best for you and your baby.

Pediatric Use

It's important to keep this product out of reach of children under 6 years old. For children aged 2 to 6 years, use only a pea-sized amount to help minimize the risk of swallowing, and make sure to supervise their brushing and rinsing until they develop good habits.

If your child is under 2 years old, it's best to consult with a dentist or doctor before use to ensure their safety and proper care.

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 condition. 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 there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the standard recommendations apply, and there are no special monitoring requirements or precautions outlined for patients with liver impairment.

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe for your liver health. They can provide guidance based on your individual situation and help monitor your liver function as needed.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking, even if there are no specific drug interactions or laboratory test interactions noted for your treatment. This ensures that your healthcare team can provide the best care tailored to your needs.

Always feel free to ask questions about how different medications might work together or affect any tests you may need. Your health and safety are the top priority, and discussing these details can help prevent any potential issues.

Storage and Handling

To ensure the best performance of your product, store it at room temperature and protect it from freezing. It's important to keep the tube tightly closed when not in use to maintain its integrity. If you notice that the product has been stored improperly after opening, please discard it to ensure safety and effectiveness. Following these guidelines will help you use the product safely and effectively.

Additional Information

The medication is administered through a dental route, meaning it is specifically used in dental settings. There are no additional details available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences. If you have any questions about how this medication is used or its effects, be sure to consult your healthcare provider for more information.

FAQ

What does this drug do?

This drug helps protect against cavities.

What age group can use this drug?

Adults and children 2 years and older can use this drug.

How should I use this drug?

Brush your teeth thoroughly after meals or at least twice a day, or use as directed by a dentist.

What should I do if a child under 2 years needs to use this drug?

Consult a dentist or doctor before use for children under 2 years of age.

Are there any warnings for children?

Keep out of reach of children under 6 years of age and supervise children 2 to 6 years to minimize swallowing.

What should I do if I accidentally swallow this drug?

If you accidentally swallow more than used for brushing, seek professional help or contact a Poison Control Center immediately.

Is this drug safe to use during pregnancy?

No specific information regarding safety during pregnancy is provided; consult a healthcare professional.

Can nursing mothers use this drug?

Nursing mothers should consult a healthcare professional before using this product due to potential excretion in breast milk.

How should I store this drug?

Store at room temperature, protect from freezing, and keep the tube tightly closed when not in use.

Packaging Info

Below are the non-prescription pack sizes of Ocean Friends Anticavity Fluoride Bubblegum Flavor (sodium fluoride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Ocean Friends Anticavity Fluoride Bubblegum Flavor.
Details

Drug Information (PDF)

This file contains official product information for Ocean Friends Anticavity Fluoride Bubblegum Flavor, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

The product is identified by the SPL code 34089-3. No specific description details are provided in the text.

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 after meals or at least twice daily, or as directed by a dentist. It is important to ensure that the product is not swallowed during use.

For children aged 2 to 6 years, a pea-sized amount of the product should be used to minimize the risk of swallowing. Caregivers should supervise the brushing and rinsing process until proper oral hygiene habits are established.

For children under 2 years of age, it is recommended to consult a dentist or doctor prior to use to ensure safety and appropriateness of the product.

Contraindications

Use is contraindicated in children under 6 years of age; the product should be kept out of their reach. In the event of accidental ingestion beyond the recommended amount for brushing, it is imperative to seek professional assistance or contact a Poison Control Center immediately.

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 of accidental swallowing of an amount greater than that used for brushing, it is crucial to seek professional medical assistance or contact a Poison Control Center immediately.

No specific general precautions or laboratory tests have been identified for this product. Healthcare professionals should remain vigilant and ensure that patients are aware of the importance of adhering to these warnings to promote safe usage.

Side Effects

Patients should be aware of the potential risks associated with the use of this product. It is crucial to keep the product out of reach of children under 6 years of age. In the event of accidental ingestion of an amount greater than that used for brushing, it is imperative to seek professional help or contact a Poison Control Center immediately.

This warning highlights the importance of proper usage and supervision to prevent serious adverse reactions in young children.

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 Ocean Friends Anticavity Fluoride Bubblegum Flavor (sodium fluoride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Ocean Friends Anticavity Fluoride Bubblegum Flavor.
Details

Pediatric Use

Pediatric patients under 6 years of age should be kept out of reach of the product. For children aged 2 to 6 years, it is recommended to use a pea-sized amount to minimize the risk of swallowing, and caregivers should supervise the child's brushing and rinsing until proper oral hygiene habits are established. For infants and children under 2 years of age, consultation with a dentist or doctor 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 Ocean Friends Anticavity Fluoride Toothpaste during pregnancy. The prescribing information does not provide safety concerns, dosage modifications, or special precautions for pregnant patients. Healthcare professionals should consider this lack of data when advising women of childbearing potential and weigh the benefits against any potential risks when recommending this product during pregnancy.

Lactation

Nursing 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. The effects on the nursing infant are not well studied; thus, the risks versus benefits should be considered.

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 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, it is imperative to seek professional assistance or contact a Poison Control Center immediately if an individual accidentally swallows more than the recommended amount used for brushing.

Healthcare professionals should be aware that prompt action is crucial in managing potential overdosage situations. Symptoms may vary depending on the substance involved, and monitoring for any adverse effects is essential.

Management procedures should include a thorough assessment of the patient's condition and the implementation of appropriate interventions based on the severity of the symptoms presented. Continuous monitoring and supportive care may be necessary until the patient is stabilized.

It is essential for healthcare providers to educate patients on the importance of adhering to recommended dosages to prevent accidental overdosage.

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 use of the compound in these contexts.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

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. It is important to emphasize the potential risks associated with misuse. Instruct patients that if they accidentally swallow more than the amount used for brushing, they should seek professional help or contact a Poison Control Center immediately. This guidance is crucial for ensuring patient safety and minimizing the risk of adverse effects.

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, away from extreme temperatures, and must be protected from freezing. To maintain the quality of the product, the tube should be kept tightly closed when not in use. If the product has been stored improperly, it should be discarded after opening to prevent any potential degradation.

Additional Clinical Information

The route of administration for the product is dental. There are no additional details available regarding laboratory tests, abuse information, patient counseling information, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Ocean Friends Anticavity Fluoride Bubblegum Flavor, 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 Ocean Friends Anticavity Fluoride Bubblegum Flavor, 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.

Learn more in our Editorial Policy

Last AI update:

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.