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Plak Smacker Anti Cavity Fluoride

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Active ingredient
Sodium Fluoride 1.4 mg/1 g
Other brand names
Dosage form
Paste
Route
Dental
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2018
Label revision date
October 16, 2023
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Sodium Fluoride 1.4 mg/1 g
Other brand names
Dosage form
Paste
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 2018
Label revision date
October 16, 2023
Manufacturer
YOUNG PS ACQUISITION, LLC
Registration number
M021
NDC root
72326-8002
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (3 NDCs)
Packaging & NDC Codes (3)

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

PLAK SMACKER® is a fluoride gel toothpaste designed to help prevent dental cavities. It comes in a fun dinosaur theme and a tasty bubble gum flavor, making it appealing for children. This toothpaste is effective in promoting oral health without any added sugar, ensuring a sweet experience without the risk of cavities.

Uses

You can use this product to help prevent dental cavities, which are small holes in your teeth caused by decay. By incorporating it into your oral care routine, you can support your dental health and reduce the risk of developing these issues. Keeping your teeth healthy is important for your overall well-being, so consider this option as part of your strategy to maintain a bright and 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 always supervise their brushing until they develop good habits.

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

What to Avoid

It's important to ensure that you use this medication safely. You should not take it if the inner foil is torn, cut, or missing, as this could compromise the integrity of the product.

Currently, there are no specific contraindications, controlled substance classifications, or noted risks of abuse, misuse, or dependence associated with this medication. Always follow the instructions provided and consult with your healthcare provider if you have any questions or concerns.

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 typically used for brushing, seek medical help or contact a Poison Control Center immediately. 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 typically used for brushing, seek medical help or contact a Poison Control Center immediately.

Before using, ensure that the inner foil is intact—do not use the product if it is torn, cut, or missing. Always prioritize safety by keeping the product away from children to prevent any accidental ingestion.

Overdose

If you accidentally swallow more of this product than what is typically used for brushing your teeth, it’s important to seek medical help immediately or contact a Poison Control Center. This is crucial to ensure your safety and receive the appropriate care.

Signs of an overdose may not be obvious, but if you experience any unusual symptoms after swallowing too much, don’t hesitate to reach out for assistance. Remember, it’s always better to be cautious when it comes to your health.

Pregnancy Use

When it comes to using this product during pregnancy, there is no specific information available about its safety or potential risks to you or your developing baby. The insert does not indicate whether the product should be avoided during pregnancy, nor does it provide any dosage adjustments or special precautions for pregnant individuals.

If you are pregnant or planning to become pregnant, it's always best to consult with your healthcare provider before using any medication or product to ensure it is safe for you and your baby.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding the use of this product while nursing. Additionally, there is no information available about whether this product is excreted in breast milk or any potential risks to your infant. Always consult with your healthcare provider if you have any concerns or questions about medications while breastfeeding.

Pediatric Use

It's important to keep this product out of the reach of children under 6 years old. If your child accidentally swallows more than the amount used for brushing, seek medical help or contact a Poison Control Center immediately. For children aged 2 years and older, encourage them to brush their teeth thoroughly, ideally after each meal or at least twice a day, following the guidance of a dentist or physician.

When helping younger children brush, use only a pea-sized amount to reduce the risk of swallowing. Always supervise their brushing until they develop good habits. If your child is under 2 years old, it's best to consult with 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 before starting the medication. 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 in the available information. This means that the usual recommendations for monitoring or safety considerations related to renal impairment (kidney issues) are not provided.

It's always best to discuss your individual situation with your healthcare provider, who can offer personalized advice and ensure that any medications you take are safe and effective for you.

Hepatic Impairment

If you have liver problems, it's important to know that there are no specific guidelines, dosage adjustments, or special monitoring requirements mentioned for your condition in the provided information. This means that the standard recommendations apply, but you should always consult your healthcare provider for personalized advice. They can help ensure that any medications you take are safe and appropriate for your liver health.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. In this case, there are no known drug interactions or laboratory test interactions associated with the medication. However, every individual is different, and your healthcare provider can help ensure that your treatment is safe and effective for you. Always feel free to ask questions and share your complete list of medications and any tests you may be undergoing.

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 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 the amount used for brushing, seek medical help or contact a Poison Control Center immediately.

For children under 6, use only a pea-sized amount to minimize swallowing, and supervise their brushing until they develop good habits. If your child is under 2 years old, consult a dentist or physician before use. Additionally, do not use the product if the inner foil is torn, cut, or missing.

FAQ

What is PLAK SMACKER®?

PLAK SMACKER® is a no sugar added, dinosaur-themed, bubble gum flavored anti-cavity fluoride gel toothpaste.

How does PLAK SMACKER® work?

It aids in the prevention of dental cavities.

Who can use PLAK SMACKER®?

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

How should I use PLAK SMACKER®?

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 when using PLAK SMACKER®?

Do not swallow the toothpaste, and use a pea-sized amount for children under 6 years. Supervise children's brushing until good habits are established.

Are there any contraindications for PLAK SMACKER®?

No contraindications are listed for PLAK SMACKER®.

What should I do if PLAK SMACKER® is accidentally swallowed?

If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

How should I store PLAK SMACKER®?

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

Is PLAK SMACKER® safe for nursing mothers?

There are no specific warnings or recommendations regarding the use of this product by nursing mothers.

Are there any known drug interactions with PLAK SMACKER®?

No drug interactions are listed for PLAK SMACKER®.

Packaging Info

Below are the non-prescription pack sizes of Plak Smacker Anti Cavity Fluoride (sodium fluoride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Plak Smacker Anti Cavity Fluoride.
Details

Drug Information (PDF)

This file contains official product information for Plak Smacker Anti Cavity Fluoride, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

PLAK SMACKER® is an anti-cavity fluoride gel toothpaste designed for children, featuring a bubble gum flavor and a dinosaur theme. This product contains no added sugar and is formulated to help prevent cavities. The net weight of the toothpaste is 4.2 oz (119 g).

Uses and Indications

This drug is indicated for the prevention of dental cavities. It is intended for use in individuals at risk of developing dental caries.

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. 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 should supervise the brushing of children's teeth until proper oral hygiene habits are established.

For children under 2 years of age, it is recommended to consult a dentist or physician prior to use to determine appropriate dental care.

Contraindications

Use is contraindicated if the inner foil is torn, cut, or missing, as this may compromise the integrity of the product and affect its safety and efficacy.

Warnings and Precautions

It is imperative to keep this product out of the reach of children under 6 years of age. In the event that more than the recommended amount for brushing is accidentally swallowed, immediate medical assistance should be sought, or contact a Poison Control Center without delay.

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

Additionally, it is essential to maintain vigilance regarding the accessibility of this product to children. Proper storage practices should be implemented to prevent 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 the reach of children under 6 years of age. In the event that more than the recommended amount is accidentally swallowed, 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 or drug and laboratory test interactions have been identified in the provided data. 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 Anti Cavity Fluoride (sodium fluoride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Plak Smacker Anti Cavity Fluoride.
Details

Pediatric Use

Pediatric patients under 6 years of age should be kept out of reach of the product. In the event that more than the recommended amount for brushing is accidentally swallowed, immediate medical assistance or contact with a Poison Control Center is advised.

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. It is important to supervise children's brushing until they have established good oral hygiene habits. For children under 2 years of age, consultation with a dentist or physician is necessary before 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, given the lack of targeted data for this population.

Pregnancy

The available prescribing information does not provide specific details regarding the use of this product during pregnancy. There are no contraindications noted for pregnant patients, nor are there any associated risks to the fetus identified in the available data. Additionally, no dosage modifications or special precautions for use during pregnancy have been specified. Healthcare professionals should consider the lack of information when advising women of childbearing potential and weigh the benefits against any potential risks when prescribing this product to pregnant patients.

Lactation

There are no specific warnings or recommendations regarding the use of this product by lactating mothers. Additionally, there is no information available about the potential for excretion in breast milk or any associated risks to breastfed infants.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information 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 caution and consider the lack of data when prescribing this medication to patients with liver problems.

Overdosage

In the event of an overdosage, it is critical to seek immediate medical assistance or contact a Poison Control Center if an amount exceeding that typically used for brushing is accidentally ingested.

Healthcare professionals should be aware that prompt intervention is essential in managing potential overdosage scenarios. Symptoms may vary depending on the specific substance involved, and monitoring for adverse effects is recommended.

Management procedures should include assessing the patient's condition and providing supportive care as necessary. It is advisable to follow established protocols for the treatment of overdosage, which may involve symptomatic treatment and monitoring of vital signs.

In all cases of suspected overdosage, the involvement of poison control and emergency medical services is crucial to ensure appropriate care and intervention.

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 in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion. It is important to emphasize that patients should not use the medication if the inner foil is torn, cut, or missing, as this may compromise the integrity of the product. Providers should ensure that patients understand these precautions to promote safe usage of the medication.

Storage and Handling

The product is supplied in configurations that include specific NDC numbers, which should be referenced for accurate identification. It is essential to store the product 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 the reach of children under 6 years of age. In the event that more than the recommended amount for brushing is accidentally swallowed, immediate medical assistance or contact with a Poison Control Center is necessary.

Patients should be instructed not to use the product if the inner foil is torn, cut, or missing. For children under 6 years, it is recommended to use a pea-sized amount to minimize swallowing, and caregivers should supervise brushing until proper habits are established. Additionally, consultation with a dentist or physician is advised for children under 2 years of age.

Drug Information (PDF)

This file contains official product information for Plak Smacker Anti Cavity Fluoride, 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 Anti Cavity Fluoride, 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.