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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
63404-0229

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Drug Overview

SprinJene Natural® is a children's toothpaste that combines the benefits of Black Seed Oil and Zinc. It is designed to help prevent cavities, freshen breath, and alleviate dry mouth, making it a supportive choice for your child's oral health. With a fun bubble gum flavor, this toothpaste aims to make brushing a more enjoyable experience for kids while promoting good dental hygiene.

Uses

You can use this medication 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 issues.

It's important to note that this medication does not have any known teratogenic effects (which means it does not cause birth defects) or nonteratogenic effects. This makes it a safe option for maintaining dental health without concerns about these specific risks.

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 2 years and older. If you're helping a child between 2 and 6 years old, make sure to teach them good brushing and rinsing habits to reduce the chance of swallowing toothpaste.

For children under 2 years old, you should avoid using this product unless a dentist or physician specifically advises you to do so. 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 product safely. Keep it out of 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 immediately.

While there are no specific contraindications or concerns about abuse, misuse, or dependence associated with this product, always follow the usage instructions carefully to ensure your 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 what is typically used for brushing, seek medical help or contact a Poison Control Center immediately. This ensures their safety and addresses any potential risks associated with ingestion.

Warnings and Precautions

It's important to keep this product out of the reach of children under 6 years of age 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 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 further guidance. Your safety is a priority, so don’t hesitate to reach out for help if needed.

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

If you are pregnant or planning to become pregnant, it's important to be aware that there is no specific information available regarding the use of this medication during pregnancy. This means that safety concerns, dosage adjustments, or any special precautions have not been clearly outlined.

Given this lack of information, it is crucial to consult with your healthcare provider before using this medication. They can help you weigh the potential risks and benefits based on your individual circumstances. Always prioritize open communication with your doctor about any medications you are considering during pregnancy.

Lactation Use

When it comes to breastfeeding, there is currently no specific information available regarding the use of this medication for nursing mothers or its effects during lactation (the period of breastfeeding). This means that if you are breastfeeding, it’s important to consult with your healthcare provider to discuss any potential risks or considerations related to your specific situation. Always prioritize your health and the well-being of your baby when making decisions about medication use while nursing.

Pediatric Use

It's important to keep this product out of reach of children under 6 years old. For children aged 2 years and older, you should supervise their use until they can handle it independently. 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.

For children between 2 and 6 years old, it's essential to teach them proper brushing and rinsing techniques to help prevent swallowing. If your child is under 2 years old, do not use this product unless specifically directed by a dentist or physician.

Geriatric Use

While there is no specific information about the use of SprinJene Natural Bubble Gum (sodium fluoride paste, dentifrice) in older adults, it’s important to consider general dental care needs as you age. Older adults may have unique health considerations, such as changes in oral health or the presence of other medical conditions, which can affect how products like this are used.

Since the drug insert does not mention any dosage adjustments or safety concerns specifically for elderly patients, it’s advisable to consult with a healthcare provider or dentist before using this product. They can provide personalized guidance based on your individual health needs and ensure that you are using it safely and effectively.

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 is safe and effective for your specific condition. They can help determine the best approach for managing your health, especially if you have concerns about your kidneys.

Hepatic Impairment

If you have liver problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or precautions related to your condition. This means that there are no tailored recommendations for how the medication may affect you differently due to your liver health.

Always consult your healthcare provider for personalized advice and to ensure that any treatment plan is safe and effective for your specific situation. They can help determine the best approach based on your liver function and overall health.

Drug Interactions

It's great to know that there are no known 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 new medications you start. Open communication helps prevent any potential issues and supports your overall well-being.

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

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 works or its specific use, be sure to consult your healthcare provider.

FAQ

What is SprinJene Natural®?

SprinJene Natural® is a children's toothpaste that contains Black Seed Oil and Zinc, designed to help prevent cavities and freshen breath.

What age group can use SprinJene Natural®?

SprinJene Natural® is suitable for adults and children 2 years of age and older. Children under 2 years should not use it unless directed by a dentist or physician.

How should I use SprinJene Natural®?

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

Are there any contraindications for using SprinJene Natural®?

There are no contraindications listed for SprinJene Natural®.

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

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

Is there any information on the use of SprinJene Natural® during pregnancy or lactation?

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

How should I store SprinJene Natural®?

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

What flavor does SprinJene Natural® come in?

SprinJene Natural® is flavored with bubble gum.

What is the net weight of SprinJene Natural®?

The net weight of SprinJene Natural® is 3.4 oz (100g).

Does SprinJene Natural® have any drug interactions?

No drug interactions information has been found for SprinJene Natural®.

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® is a children's toothpaste formulated for cavity protection, featuring Black Seed Oil and Zinc. This product is presented in a bubble gum flavor, designed to appeal to children while effectively freshening breath and assisting in alleviating dry mouth. The net weight of the toothpaste is 3.4 ounces (100 grams).

Uses and Indications

This drug is indicated for the prevention of cavities.

There are no teratogenic effects associated with this drug. Additionally, no nonteratogenic effects have been reported.

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 a day, as directed by a dentist or physician.

For children aged 2 to 6 years, it is important to instruct them in proper brushing and rinsing techniques to minimize the risk of swallowing.

The use of this product is not recommended for children under 2 years of age unless specifically 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 of accidental swallowing of an amount greater than that used for brushing, 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 to prevent accidental ingestion and potential harm.

In the event that more than the recommended amount 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 crucial to keep the product out of 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 imperative 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 drug interactions or drug and laboratory test interactions have been identified for this product. Therefore, no specific recommendations for dosage adjustments or monitoring are necessary at this time.

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 the product. Supervision is recommended for children until they are capable of using the product without assistance. For children aged 2 years and older, it is advised 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 techniques to minimize the risk of swallowing. The product is not recommended for use in children under 2 years of age unless specifically directed by a dentist or physician.

Geriatric Use

There is no specific information regarding the use of SprinJene Natural Bubble Gum (sodium fluoride paste, dentifrice) in geriatric patients. The prescribing information does not provide guidance on dosage adjustments, safety concerns, or special precautions for elderly patients. Therefore, healthcare providers should exercise caution and consider individual patient factors when prescribing this product to geriatric patients, as the absence of specific data necessitates careful monitoring and assessment of treatment outcomes in this population.

Pregnancy

There is no specific information regarding the use of this medication during pregnancy, including safety concerns, dosage modifications, or special precautions. Healthcare professionals should consider the lack of data when prescribing this medication to pregnant patients. The potential risks and benefits should be carefully evaluated, and alternative treatments may be considered in the absence of established safety profiles. Women of childbearing potential should be counseled on the importance of effective contraception while using this medication.

Lactation

There is no specific information available regarding the use of this medication in nursing mothers or any considerations related to lactation. Healthcare professionals should exercise caution and consider the potential risks and benefits when prescribing this medication to lactating mothers. Further research may be necessary to fully understand the implications for breastfed infants.

Renal Impairment

Patients with renal impairment may not have specific dosage adjustments, special monitoring, or safety considerations outlined in the prescribing information. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment and monitoring of these patients.

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, immediate medical assistance is crucial. If an individual accidentally swallows more than the amount typically used for brushing, it is imperative to seek medical help or contact a Poison Control Center without delay.

Healthcare professionals should be aware that prompt intervention can mitigate potential adverse effects associated with overdosage. Monitoring for symptoms and providing appropriate management based on clinical presentation is essential. It is recommended that healthcare providers familiarize themselves with local Poison Control resources to ensure rapid access to expert guidance in such situations.

Nonclinical Toxicology

No relevant information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no pertinent data concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

No postmarketing experience details are provided in the insert for SPL code 90375-7.

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 more than the recommended amount used for brushing is accidentally swallowed, they should seek medical help or contact a Poison Control Center immediately. This guidance is crucial for ensuring patient safety and appropriate response in case of accidental ingestion.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers, which should be referenced for accurate identification. It is essential to store the product at room temperature, ensuring that it is protected from light exposure to maintain its integrity. Freezing the product is strictly prohibited, as it may compromise its effectiveness. 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. There is no additional information available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

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.