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Cinnafresh

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Active ingredient
Sodium Fluoride 2.2 mg/1 g
Other brand names
Dosage form
Gel, Dentifrice
Route
Dental
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2008
Label revision date
August 22, 2024
Active ingredient
Sodium Fluoride 2.2 mg/1 g
Other brand names
Dosage form
Gel, Dentifrice
Route
Dental
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2008
Label revision date
August 22, 2024
Manufacturer
Bob Barker Company Inc.
Registration number
M021
NDC root
53247-134

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Drug Overview

CinnaFresh® is an anticavity gel toothpaste designed to help protect your teeth against cavities. It contains sodium fluoride (0.22%), which is an important ingredient that strengthens tooth enamel and reduces the risk of decay.

With its bold cinnamon flavor, CinnaFresh® not only promotes dental health but also makes brushing your teeth a more enjoyable experience.

Uses

You can use this product to help protect your teeth against cavities. Cavities are areas of decay that can develop on your teeth, leading to discomfort and more serious dental issues if not treated. By using this product, you can take an important step in maintaining your oral health and keeping your smile bright.

Rest assured, there are no known teratogenic effects (which means it does not cause birth defects) or nonteratogenic effects associated with this product. This makes it a safe option for your dental care routine.

Dosage and Administration

To keep your teeth healthy, it's important to brush them thoroughly, ideally after each meal or at least twice a day. This applies to both adults and children aged 6 years and older. If you have any specific instructions from your dentist or doctor, be sure to follow those as well.

For children aged 2 to 6 years, use only a pea-sized amount of toothpaste. It's essential to supervise their brushing and rinsing to help prevent them from swallowing the toothpaste. If your child is under 2 years old, it's best to consult with a dentist or physician before using any toothpaste. This way, you can ensure that you're taking the right steps for their dental health.

What to Avoid

It's important to ensure that you use this product safely. Keep it out of the 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 or contact a Poison Control Center right away.

There are no specific contraindications, controlled substance classifications, or concerns about abuse, misuse, or dependence associated with this product. However, always use it as directed to ensure your safety and well-being.

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 right away.

Please be aware of these precautions to ensure safety while using the product.

Warnings and Precautions

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

Always use this product as directed. If you experience any unusual symptoms or reactions, stop using it and call your doctor for further advice. Your safety is a priority, so don’t hesitate to reach out for help if you have any concerns.

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 right away or contact a Poison Control Center. This is crucial to ensure your safety and receive the appropriate care.

Signs of an overdose may not always be obvious, so it's best to err on the side of caution. If you have any concerns about your health after swallowing too much, don’t hesitate to reach out for assistance. Your well-being is the priority, and prompt action can make a difference.

Pregnancy Use

When considering the use of CinnaFresh (sodium fluoride gel, dentifrice) during pregnancy, it's important to note that there is no specific information available regarding its safety, dosage adjustments, or any special precautions for pregnant individuals. This means that the effects of this product on pregnancy have not been clearly studied or established.

If you are pregnant or planning to become pregnant, it’s always best to consult with your healthcare provider before using any new products, including dental care items like CinnaFresh. They can provide personalized advice based on your health needs and circumstances.

Lactation Use

If you are breastfeeding, it's important to know that there is no specific information available regarding the use of this medication while nursing. This means that the effects on breast milk production and your nursing infant are not clearly defined.

As always, it's best to consult with your healthcare provider about any medications you are considering while breastfeeding to ensure the safety and well-being of both you and your baby.

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 right away.

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, 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 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 be adjusted 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 provide guidance based on your individual health needs.

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 discuss any concerns you may have regarding your liver function and how it relates to your treatment. They can help ensure that your medication is safe and effective for you.

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 monitor your health effectively and make informed decisions about your care.

Always feel free to ask questions and share all the medications and supplements you are using. This helps to avoid any potential issues and ensures that your treatment is as safe and effective as possible.

Storage and Handling

To ensure the best performance of your product, store it at room temperature, away from direct light. It's important to keep it in a safe place where it won't be exposed to freezing temperatures, as freezing can damage the product.

When handling the product, always do so with clean hands and in a clean environment to maintain its integrity. Following these simple 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 experiences reported after the medication has been on the market. If you have any questions about how this medication is used or its effects, be sure to consult your healthcare provider.

FAQ

What is CinnaFresh®?

CinnaFresh® is an anticavity gel toothpaste that helps protect against cavities.

What is the active ingredient in CinnaFresh®?

The active ingredient in CinnaFresh® is Sodium Fluoride at a concentration of 0.22%.

Who can use CinnaFresh®?

CinnaFresh® is suitable for adults and children 6 years of age and older. For children aged 2 to 6, use only a pea-sized amount and supervise their brushing.

What should I do if a child under 2 years needs to use CinnaFresh®?

If a child is under 2 years old, you should ask a dentist or physician before use.

Are there any contraindications for using CinnaFresh®?

There are no contraindications listed for CinnaFresh®.

What should I do if more than the recommended amount is swallowed?

If more than the amount used for brushing is accidentally swallowed, seek medical help or contact a Poison Control Center immediately.

How should CinnaFresh® be stored?

CinnaFresh® should be stored at room temperature, protected from light, and should not be frozen.

Is CinnaFresh® safe to use during pregnancy or while nursing?

No specific information regarding the use of CinnaFresh® during pregnancy or lactation is provided.

What flavor does CinnaFresh® have?

CinnaFresh® has a bold cinnamon flavor.

Packaging Info

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

Packaging configurations for Cinnafresh.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

CinnaFresh® is an anticavity gel toothpaste formulated with 0.22% sodium fluoride. It is designed to provide effective dental care while delivering a bold cinnamon flavor. The product is packaged in a net weight of 0.85 ounces (24 grams).

Uses and Indications

This drug is indicated for the protection against cavities.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Adults and children aged 6 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 before use.

Contraindications

Use is contraindicated in children under 6 years of age due to the risk of accidental ingestion. In the event of accidental swallowing of an amount greater than that used for brushing, seek medical 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 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 a Poison Control Center without delay to ensure appropriate management and care.

Side Effects

Patients should be aware of the following warnings associated with the use of this product. It is imperative to keep the 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, it is crucial to seek medical assistance or contact a Poison Control Center immediately.

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

No specific drug interactions have been identified in the available data. Additionally, there are no reported interactions with laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on the current information.

Packaging & NDC

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

Packaging configurations for Cinnafresh.
Details

Pediatric Use

Pediatric patients under 6 years of age should be kept out of reach of children. For children aged 2 to 6 years, it is recommended to use only a pea-sized amount of the product and to supervise the child's brushing and rinsing to minimize the risk of swallowing. In the event that more than the recommended amount is accidentally swallowed, medical assistance should be sought immediately, or contact a Poison Control Center. For children under 2 years, 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 CinnaFresh (sodium fluoride gel, dentifrice) during pregnancy. The prescribing information does not provide safety concerns, dosage modifications, or special precautions for pregnant patients. Therefore, healthcare professionals should exercise caution when recommending this product to women of childbearing potential and consider the absence of data when assessing the potential risks and benefits for pregnant patients.

Lactation

There is no specific information available regarding the use of this medication in nursing mothers or its effects on lactation. Consequently, healthcare professionals should exercise caution when prescribing this medication to lactating mothers, as the potential risks to breastfed infants are not well characterized. It is advisable to consider the benefits of breastfeeding alongside the potential risks associated with the medication.

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, 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 complications associated with overdosage. Symptoms may vary depending on the specific substance involved, and monitoring for adverse effects is recommended.

Management procedures should include supportive care and symptomatic treatment as necessary. It is advisable to have the product's labeling and any relevant patient information available when seeking assistance from medical professionals or poison control.

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 question. Further studies may be necessary to elucidate these aspects of nonclinical toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert.

Patient Counseling

Healthcare providers should advise patients to keep the product out of the reach of children under 6 years of age to prevent accidental ingestion. It is important to emphasize that if more than the recommended amount used for brushing is accidentally swallowed, patients should seek medical help or contact a Poison Control Center immediately. This information is crucial for ensuring the safety and well-being of patients and their families.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It should be stored at room temperature, ensuring that it is protected from light exposure. Additionally, it is crucial to avoid freezing the product to maintain its integrity and effectiveness. Proper handling and storage conditions are essential to ensure the product remains within its specified parameters.

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, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Cinnafresh, 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 Cinnafresh, 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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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.