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Sprinjene

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This product has been discontinued

Active ingredient
Sodium Fluoride 1.5 mg/1 g
Other brand names
Dosage form
Paste, Dentifrice
Route
Dental
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2024
Label revision date
May 7, 2024
Active ingredient
Sodium Fluoride 1.5 mg/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 2024
Label revision date
May 7, 2024
Manufacturer
Health and Natural Beauty USA Corp
Registration number
M021
NDC root
63404-6319

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

SprinJene Natural Total Care Cavity Protection Toothpaste is designed to help you maintain good oral health by preventing cavities and removing surface stains with regular brushing. This toothpaste features the unique benefits of black seed oil and zinc, which work together to remineralize enamel, freshen breath, and assist with dry mouth.

In addition to its cavity-fighting properties, SprinJene is free from sodium lauryl sulfate (SLS), preservatives, and dyes, making it a gentle option for your daily dental care routine. It also contains natural peppermint oil for a refreshing taste, and it is certified vegan and gluten-free, ensuring it meets various dietary preferences.

Uses

Using this product can be beneficial for your dental health in several ways. It helps prevent cavities, which are small holes in your teeth caused by decay. Additionally, with regular brushing, it aids in removing surface stains, keeping your teeth looking brighter and cleaner.

Moreover, this product helps prevent plaque buildup, which is a sticky film of bacteria that can lead to gum disease if not managed properly. By incorporating this into your oral care routine, you can maintain a healthier smile and reduce the risk of dental issues.

Dosage and Administration

It's important to ensure that children are supervised while brushing their teeth until they can do it safely on their own. For adults and children aged 2 years and older, you should brush your teeth thoroughly, ideally after each meal or at least twice a day, following the guidance of your dentist or physician.

If you have children between the ages of 2 and 6, make sure to teach them good brushing and rinsing habits to help prevent swallowing toothpaste. For children under 2 years old, do not use this product unless specifically directed by a dentist or physician.

What to Avoid

It's important to keep this product out of reach of children under 6 years of age to ensure their safety. If a child accidentally swallows more than what is typically used for brushing, seek medical help or contact a poison control center immediately.

While there are no specific contraindications, controlled substance classifications, or concerns about abuse, misuse, or dependence associated with this product, always use it as directed to avoid any potential issues. Your safety is a priority, so please follow these guidelines carefully.

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 or contact a poison control center immediately. This precaution helps ensure safety and prevent any potential harm.

Warnings and Precautions

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 typically used for brushing, you should seek medical help or contact a poison control center immediately.

Always use this product as directed and be aware of any unusual reactions. If you experience any concerning symptoms or side effects, stop using the product and call your doctor for advice. Your safety is a priority, so don’t hesitate to reach out for help if needed.

Overdose

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 typically used for brushing their teeth, you should seek medical help or contact a poison control center immediately.

Signs of an overdose can vary, but if you notice unusual symptoms or if someone has ingested too much, don't hesitate to get help right away. Always prioritize safety and act quickly in these situations.

Pregnancy Use

When it comes to using SprinJene Natural Total Care Cavity Protection (sodium fluoride paste, dentifrice) during pregnancy, there is no specific information available about its safety, 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 consult with your healthcare provider before using this product. They can help you understand any potential risks and guide you on the best oral care practices during this time. Always prioritize your health and the health of your baby by seeking professional advice.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding nursing mothers in the information provided. Additionally, there are no particular considerations or precautions mentioned for lactation. This suggests that the use of the medication may not pose significant risks to you or your nursing infant. However, it's always a good idea to consult with your healthcare provider about any concerns you may have while 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 used for brushing, seek medical help or contact a poison control center immediately. Always supervise children until they can use the product safely on their own.

For children aged 2 years and older, encourage them to brush their teeth thoroughly, ideally after each meal or at least twice a day, as recommended by a dentist or physician. Teach children aged 2 to 6 about good brushing and rinsing habits to help prevent swallowing the product. Avoid using it for children under 2 years unless specifically directed by a dentist or physician.

Geriatric Use

When considering the use of SprinJene Natural Total Care Cavity Protection, it's important to note that there is no specific information available regarding its use in older adults. This means that there are no recommended dosage adjustments, safety concerns, or special precautions outlined for elderly patients.

If you are an older adult or a caregiver, it’s always a good idea to consult with a healthcare professional before starting any new product, especially if there are existing health conditions or medications involved. This ensures that you can make informed decisions that prioritize safety and well-being.

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 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 if you have hepatic impairment (liver issues).

Always consult your healthcare provider for personalized advice and to discuss any concerns you may have regarding your liver health and medication use. They can help ensure that you receive the safest and most effective treatment based on your individual needs.

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 keep it away from direct light. It's important not to freeze the product, as this can affect its effectiveness. Once you open the product, be sure to discard it after use to maintain safety and quality.

By following these simple storage and handling guidelines, you can help ensure that the product remains safe and effective for your needs.

Additional Information

You will use this medication through a dental route, which means it is applied in a dental setting. If you are a parent or guardian, it's important to supervise children while they use this product until they can do so safely on their own. For children aged 2 to 6 years, make sure to teach them proper brushing and rinsing techniques to help reduce the risk of swallowing the product.

FAQ

What is SprinJene Natural Total Care Cavity Protection Toothpaste used for?

It helps in the prevention of cavities, removes surface stains with regular brushing, and prevents plaque buildup.

What are the key ingredients in this toothpaste?

It contains black seed oil and zinc, which provide unique benefits, along with natural peppermint oil for freshening breath.

Is this toothpaste safe for children?

Children under 2 years should not use it unless directed by a dentist or physician. Supervise children as necessary until they can use it without supervision.

How should I use this toothpaste?

Adults and children 2 years and older should brush their teeth thoroughly, preferably after each meal or at least twice a day as directed by a dentist or physician.

Are there any contraindications for using this toothpaste?

No contraindications are listed for SprinJene Natural Total Care Cavity Protection Toothpaste.

What should I do if more toothpaste is accidentally swallowed?

If more than used for brushing is accidentally swallowed, get medical help or contact a poison control center right away.

Is this toothpaste vegan and gluten-free?

Yes, it is certified vegan and gluten-free.

How should I store this toothpaste?

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

Does this toothpaste have any teratogenic effects?

No teratogenic effects are mentioned for this toothpaste.

Can nursing mothers use this toothpaste?

There are no specific warnings or recommendations regarding nursing mothers in the provided information.

Packaging Info

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

Packaging configurations for Sprinjene.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

SprinJene Natural® Total Care Cavity Protection Toothpaste is formulated with the unique benefits of black seed oil and zinc. This toothpaste is designed to provide whitening effects, remineralize enamel, freshen breath, and assist with dry mouth. It is presented in a net weight of 5 oz (142 g) and is free from sodium lauryl sulfate (SLS), preservatives, and dyes. The product contains natural peppermint oil and is certified as a 100% USDA biobased product. Additionally, it is certified vegan by Vegan.org and is gluten-free.

Uses and Indications

This drug is indicated for the prevention of dental cavities. It aids in the removal of surface stains when used with regular brushing and helps prevent plaque buildup.

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

Dosage and Administration

Healthcare professionals are advised to supervise children as necessary until they are capable of using the product without supervision.

For adults and children aged 2 years and older, it is recommended to brush teeth thoroughly, preferably after each meal or at least twice a day, as directed by a dentist or physician.

Children aged 2 to 6 years should be instructed in proper brushing and rinsing habits to minimize the risk of swallowing the product.

For children under 2 years of age, the product should not be used unless directed by a dentist or physician.

Contraindications

Use is contraindicated in children under 6 years of age due to the risk of accidental ingestion. 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.

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 used for brushing is accidentally swallowed, immediate medical assistance should be sought, or contact with a poison control center is advised without delay.

Healthcare professionals should ensure that caregivers are aware of these critical safety measures to prevent accidental ingestion and potential harm to young children.

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. In the event that more than the recommended amount used for brushing is accidentally swallowed, it is imperative to seek medical help or contact a poison control center immediately. This precaution is essential to ensure the safety and well-being of young children who may inadvertently ingest the product.

Drug Interactions

There are no reported drug interactions associated with the use of this medication. Additionally, no interactions with laboratory tests have been identified. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug interactions.

Packaging & NDC

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

Packaging configurations for Sprinjene.
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 or contact with a poison control center is advised.

Children should be supervised as necessary until they are capable of using the product without supervision. For children aged 2 years and older, it is recommended to brush teeth thoroughly, preferably after each meal or at least twice a day, as directed by a dentist or physician.

Parents and caregivers should instruct children aged 2 to 6 years in proper brushing and rinsing techniques to minimize swallowing. The use of this product is not recommended for children under 2 years of age unless directed by a dentist or physician.

Geriatric Use

There is no specific information regarding the use of SprinJene Natural Total Care Cavity Protection in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise clinical judgment when considering the use of this product in elderly patients, as individual patient factors may influence safety and efficacy. Monitoring for any adverse effects is advisable when administering this product to the geriatric population.

Pregnancy

There is no specific information regarding the use of SprinJene Natural Total Care Cavity Protection (sodium fluoride paste, 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 and consider the lack of data when advising women of childbearing potential regarding the use of this product during pregnancy.

Lactation

There are no specific warnings or recommendations regarding nursing mothers. Additionally, there are no specific considerations or precautions mentioned related to lactation.

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

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 overdosage, it is crucial to ensure that the product is kept out of reach of children under 6 years of age. Accidental ingestion of amounts exceeding those recommended for brushing may lead to adverse effects.

If more than the recommended amount is swallowed, immediate medical assistance should be sought. Healthcare professionals are advised to contact a poison control center without delay to obtain guidance on the appropriate management of the situation.

Prompt action is essential to mitigate potential risks associated with overdosage, and healthcare providers should be prepared to assess and manage any symptoms that may arise from such an incident.

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 provided in the insert.

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.

In the event that more than the recommended amount is accidentally swallowed, patients should be instructed to seek medical help or contact a poison control center immediately. This guidance is crucial for ensuring patient safety and addressing any potential emergencies effectively.

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 protected from light exposure. Freezing the product is not permitted, as it may compromise its integrity. Additionally, once opened, the product must be discarded to ensure safety and efficacy.

Additional Clinical Information

The route of administration for the product is dental. Clinicians should supervise children as necessary until they are capable of using the product without supervision. Additionally, it is important to instruct children aged 2 to 6 years on proper brushing and rinsing habits to minimize the risk of swallowing.

Drug Information (PDF)

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