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Plak Smacker Great White Shark Cool Berry Flavor Anti Cavity Fluoride Gel Tooth

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Active ingredient
Sodium Fluoride 0.1 g/100 g
Other brand names
Dosage form
Paste, Dentifrice
Route
Dental
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2025
Label revision date
January 16, 2025
Active ingredient
Sodium Fluoride 0.1 g/100 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 2025
Label revision date
January 16, 2025
Manufacturer
Yangzhou ONE & ONLY Personal Care Products Co. , LTD
Registration number
M021
NDC root
85162-003

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

Drug Overview

This medication is designed to help prevent cavities, which are small holes in your teeth caused by decay. By using this product, you can take an important step towards maintaining your dental health and keeping your smile bright. It's a supportive tool in your oral care routine, helping to protect your teeth from the harmful effects of plaque and bacteria.

Uses

You can use this product to help prevent cavities, which are small holes in your teeth caused by decay. By incorporating it into your dental care routine, you can support your oral health and reduce the risk of developing these dental issues. Regular use can be an effective way to maintain a healthy smile.

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 under 6, use only a pea-sized amount of toothpaste to minimize the chance of swallowing, and make sure to supervise their brushing until they develop good habits.

For children younger than 2 years, it's best to consult with a dentist or physician before starting any brushing routine. Remember, do not swallow the toothpaste, as it's meant for cleaning your teeth, not for ingestion. Following these guidelines will help ensure proper dental care for you and your family.

What to Avoid

It's important to keep this medication out of reach of children to ensure their safety. There are no specific contraindications, controlled substance classifications, or concerns regarding abuse, misuse, or dependence associated with this medication. Always follow the guidance provided by your healthcare professional and use the medication responsibly.

Side Effects

It's important to keep this product out of the reach of children under 6 years old. If a child accidentally swallows more than what is used for brushing, seek medical help or contact a Poison Control Center right away. Additionally, do not use the product if the inner foil is torn, cut, or missing, as this could indicate that the product is compromised.

Warnings and Precautions

It's important to keep this product out of the reach of children under 6 years old. If a child accidentally swallows more than what is needed for brushing, seek medical help or contact a Poison Control Center right away.

Before using, make sure the inner foil is intact; do not use the product if it is torn, cut, or missing. Always store it safely to prevent accidental ingestion. If you have any concerns or experience unusual reactions, stop using the product and consult your doctor.

Overdose

It's important to keep this medication out of the reach of children under 6 years old. If a child accidentally swallows more than the amount used for brushing, you should seek medical help or contact a Poison Control Center right away.

Signs of an overdose can vary, but if you notice unusual symptoms or if someone has taken more than the recommended dose, it's crucial to act quickly. Always prioritize safety and don't hesitate to reach out for professional assistance in these situations.

Pregnancy Use

When it comes to using this medication during pregnancy, there is no specific information available about its safety, recommended dosage adjustments, or any special precautions you should take. This means that if you are pregnant or planning to become pregnant, it’s important to discuss your options with your healthcare provider. They can help you understand any potential risks and make informed decisions about your treatment. Always prioritize open communication with your doctor regarding any medications you are considering during this time.

Lactation Use

When it comes to breastfeeding, it's important to be aware that there are no specific guidelines or statements regarding nursing mothers or lactation (the process of producing milk). This means that if you are breastfeeding, you may not find detailed information about how certain medications or treatments could affect you or your baby.

If you have concerns about breastfeeding while taking any medication, it's always best to consult with your healthcare provider for personalized advice and to ensure the safety of both you and your infant.

Pediatric Use

It's important to keep this product out of the reach of children under 6 years old. If a child accidentally swallows more than the amount used for brushing, seek medical help or contact a Poison Control Center right away. 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.

When brushing for children under 6, use only a pea-sized amount to help minimize swallowing. It's also essential to supervise their brushing until they develop good habits. If your child is under 2 years old, please 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, it’s important to consult with a healthcare provider for personalized advice. 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 there are no specific guidelines or dosage adjustments mentioned for your condition. This means that the information available does not provide special monitoring or safety considerations tailored for patients with renal impairment (kidney issues).

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe and appropriate for your kidney health. They can help you understand how your condition may affect your treatment.

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 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 tailored to your specific situation.

Drug Interactions

It's great to know that there are no reported 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 medications. They can help you understand how different treatments may work together and monitor your health appropriately.

Storage and Handling

To ensure the best performance of your product, store it at room temperature and avoid freezing, as extreme cold can damage it. It's also important to keep the product protected from light to maintain its effectiveness. Once you open the product, be sure to discard it after use to ensure safety and prevent contamination. Following these simple guidelines will help you use the product safely and effectively.

Additional Information

This product is administered through the dental route, meaning it is used in the mouth. It's important to keep this product out of the reach of children under 6 years old. If a child accidentally swallows more than what is needed for brushing, seek medical help or contact a Poison Control Center right away.

Make sure not to use the product if the inner foil is torn, cut, or missing. It's also essential to supervise children's brushing until they develop good habits. If your child is under 2 years old, consult a dentist or physician before use.

FAQ

What is the purpose of this drug?

This drug aids in the prevention of cavities.

Who can use this drug?

Adults and children 2 years of age and older can use this drug. Children under 2 years of age should consult a dentist or physician.

How should I use this drug?

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

What precautions should I take for children?

Supervise children's brushing until good habits are established, and use a pea-sized amount to minimize swallowing in children under 6 years.

What should I do if a child accidentally swallows this drug?

If a child accidentally swallows more than used for brushing, get medical help or contact a Poison Control Center immediately.

What should I do if the inner foil is damaged?

Do not use the drug if the inner foil is torn, cut, or missing.

How should I store this drug?

Store at room temperature, protect from light, and do not freeze. Discard after opening.

Are there any contraindications for this drug?

No specific contraindications are listed for this drug.

Is there any information regarding use during pregnancy or lactation?

No specific information regarding use during pregnancy or lactation is provided.

What should I do if I have questions about using this drug?

Consult your dentist or physician if you have any questions or concerns about using this drug.

Packaging Info

Below are the non-prescription pack sizes of Plak Smacker Great White Shark Cool Berry Flavor Anti Cavity Fluoride Gel Tooth (sodium fluoride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Plak Smacker Great White Shark Cool Berry Flavor Anti Cavity Fluoride Gel Tooth.
Details

Drug Information (PDF)

This file contains official product information for Plak Smacker Great White Shark Cool Berry Flavor Anti Cavity Fluoride Gel Tooth, 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 additional specific description details are provided.

Uses and Indications

This drug is indicated for the prevention of dental caries (cavities). It is intended for use in individuals seeking to reduce the risk of developing cavities as part of a comprehensive oral health regimen.

Dosage and Administration

Adults and children aged 2 years and older should brush their teeth thoroughly, preferably after each meal or at least twice daily, or as directed by a dentist or physician. It is important to ensure that the product is not swallowed during use.

For children under 6 years of age, a pea-sized amount of the product should be used to minimize the risk of swallowing. Caregivers are advised to supervise the brushing of children's teeth until proper oral hygiene habits are established.

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

Contraindications

There are no specific contraindications listed for this product. However, it is advised to keep the product out of reach of children to prevent accidental ingestion or misuse.

Warnings and Precautions

It is imperative to keep this product out of the reach of children under 6 years of age. In the event of accidental ingestion of an amount greater than that typically used for brushing, immediate medical assistance should be sought, or contact with a Poison Control Center is advised.

The integrity of the product packaging is crucial for safe use. Therefore, it should not be utilized if the inner foil is torn, cut, or missing, as this may compromise the product's safety and efficacy.

Additionally, continuous vigilance is required to ensure that the product remains out of reach of children to prevent accidental ingestion or misuse.

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 the reach of children under 6 years of age. In the event of accidental ingestion of an amount greater than what is typically used for brushing, patients are advised to seek medical assistance or contact a Poison Control Center immediately.

Additionally, the product should not be used if the inner foil is torn, cut, or missing, as this may compromise its safety and efficacy.

Drug Interactions

No drug interactions have been identified in the available data. Additionally, there are no reported interactions between drugs and laboratory tests. Therefore, no specific recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Plak Smacker Great White Shark Cool Berry Flavor Anti Cavity Fluoride Gel Tooth (sodium fluoride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Plak Smacker Great White Shark Cool Berry Flavor Anti Cavity Fluoride Gel Tooth.
Details

Pediatric Use

Pediatric patients under 6 years of age should be kept out of reach of the product. In the event of accidental ingestion of more than the amount used for brushing, medical assistance or contact with a Poison Control Center is advised immediately.

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. To minimize the risk of swallowing, a pea-sized amount of the product should be used for children under 6 years.

Parents and caregivers are encouraged to supervise children's brushing until proper oral hygiene habits are established. For children under 2 years of age, consultation with a dentist or physician is recommended 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. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

There is no specific information available regarding the use of this medication during pregnancy, including safety concerns, dosage modifications, or special precautions that should be taken. Healthcare professionals should consider the lack of data when prescribing this medication to pregnant patients and weigh the potential risks and benefits. It is advisable to monitor any pregnant patients closely and to discuss alternative treatment options if necessary.

Lactation

There are no specific statements regarding the use of this medication in nursing mothers or its effects during lactation. Additionally, there is no available data on the excretion of this medication in breast milk or its potential effects on breastfed infants. Healthcare professionals should consider the absence of information when advising lactating mothers about the use of this medication.

Renal Impairment

There is no specific information regarding renal impairment, dosage adjustments, special monitoring, or safety considerations for patients with reduced kidney function. Healthcare professionals should exercise caution when prescribing to patients with renal impairment, as the absence of detailed guidance necessitates careful clinical judgment and monitoring.

Hepatic Impairment

There is no information available regarding the use of this medication in patients with hepatic impairment. Consequently, there are no dosage adjustments, special monitoring requirements, or precautions specified for individuals with compromised liver function. Healthcare professionals should exercise clinical judgment when considering the use of this medication in patients with liver problems, as the absence of specific guidance necessitates careful evaluation of the patient's overall health status and liver function.

Overdosage

In the event of overdosage, it is crucial to keep the product out of the reach of children under 6 years of age. Accidental ingestion of amounts exceeding the recommended dosage for brushing may lead to serious health concerns.

Healthcare professionals are advised to instruct caregivers to seek immediate medical assistance or contact a Poison Control Center if an overdose occurs. Prompt action is essential to mitigate potential adverse effects associated with 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 compound in these areas.

Postmarketing Experience

No postmarketing experience details are available for the product associated with SPL code 90375-7.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion or misuse. It is important to emphasize the necessity of proper storage to ensure the safety of young individuals.

Storage and Handling

The product is supplied in packaging that includes specific NDC numbers. It should be stored at room temperature, ensuring that it is not exposed to freezing conditions. Additionally, the product must be protected from light to maintain its integrity. Once opened, the product should be discarded to ensure safety and efficacy.

Additional Clinical Information

The product is administered via the dental route. Clinicians should advise patients to keep the product out of reach of children under 6 years of age. In the event of accidental ingestion of more than the amount used for brushing, patients should seek medical assistance or contact a Poison Control Center immediately. It is important to ensure that the inner foil is intact before use, and parents should supervise children's brushing until proper habits are established. For children under 2 years of age, consultation with a dentist or physician is recommended.

Drug Information (PDF)

This file contains official product information for Plak Smacker Great White Shark Cool Berry Flavor Anti Cavity Fluoride Gel Tooth, 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 Plak Smacker Great White Shark Cool Berry Flavor Anti Cavity Fluoride Gel Tooth, 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

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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.