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Super Strawberry

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Active ingredient
Sodium Fluoride 2.4 mg/1 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
July 5, 2025
Active ingredient
Sodium Fluoride 2.4 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 2025
Label revision date
July 5, 2025
Manufacturer
SuperMouth, LLC.
Registration number
M021
NDC root
83729-116

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

Super Strawberry Fluoride Toothpaste is a dental care product designed to help prevent cavities. It combines the benefits of fluoride, which is known for its ability to strengthen tooth enamel and protect against decay, with a fun strawberry flavor that makes brushing enjoyable for both kids and adults. Manufactured by SuperMouth, this toothpaste is safe and effective, making it a great choice for maintaining oral health.

Uses

You can use this product to help prevent cavities, which are small holes in your teeth caused by decay. It's important to maintain good oral hygiene, and this product can be a helpful part of your routine to keep your teeth healthy.

Rest assured, there are no known teratogenic effects (which means it doesn't cause birth defects) associated with this product, making it safe for use.

Dosage and Administration

When it comes to using this dental product for your child, the amount you should use depends on their age. For children under 3 years old, you should apply no more than a tiny smear, about the size of a grain of rice. If your child is between 3 and 6 years old, a pea-sized amount is sufficient.

To use the product, place it on a SuperMouth® toothbrush and help your child brush their teeth thoroughly for at least two minutes, twice a day. It's important to supervise your child during brushing and rinsing to reduce the risk of swallowing the product. If you have any specific instructions from a dentist or physician, be sure to follow those as well.

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.

There are no specific contraindications, controlled substance classifications, or noted risks of abuse, misuse, or dependence associated with this product. However, 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 quickly.

Warnings and Precautions

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

Always use this product as directed, and be cautious about the amount used. If you have any concerns or experience unusual symptoms, don’t hesitate to reach out to your healthcare provider for guidance.

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 can vary, 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

There is currently no specific information available regarding the use of Super Strawberry Fluoride Toothpaste during pregnancy. This means that the drug insert does not provide details on safety concerns, dosage adjustments, or any special precautions you should take while pregnant.

If you are pregnant or planning to become pregnant, it's always a good idea to consult with your healthcare provider about any products you plan to use, including toothpaste, to ensure they are safe for you and your baby.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to consult with your healthcare professional before using this product. There is a possibility that it may be excreted in breast milk, which means caution is advised when considering its use. Additionally, the safety of this product during lactation has not been established, so it's essential to weigh the potential risks and benefits with your doctor.

Pediatric Use

It's important to keep this product out of reach of children under 6 years old. For children under 3 years, you should only use a tiny smear, about the size of a grain of rice. If your child is between 3 and 6 years old, a pea-sized amount is appropriate.

When using the product, place it on a SuperMouth® toothbrush and help your child brush their teeth thoroughly for at least 2 minutes, twice a day. Always supervise your child during brushing and rinsing to reduce the risk of swallowing the product. If you have any questions, consult your dentist or physician for guidance.

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 there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the standard recommendations for the medication do not include 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 medication you take is safe and appropriate for your situation. They can help determine the best course of action based on your kidney health.

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 should be used if you have hepatic impairment (liver issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your liver health. They can help you understand how to manage your treatment effectively.

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 interactions with laboratory tests for the medication in question. However, always ensure that your healthcare provider is aware of all the medications you are using, as this helps them provide the best care tailored to your needs.

By discussing your full medical history and any other treatments, you can help prevent potential issues and ensure your safety.

Storage and Handling

To ensure the safety and effectiveness of your product, always follow the instructions provided on the label. Proper storage and handling are crucial, so make sure to keep the product in a suitable environment as specified. This may include maintaining specific temperature ranges and ensuring that the product is kept in a clean, sterile area to prevent contamination.

When handling the product, be cautious and follow any guidelines related to safety and disposal. This will help you use the product correctly and minimize any risks associated with improper handling. Remember, adhering to the label instructions is key to achieving the best results.

Additional Information

No further information is available.

FAQ

What is Super Strawberry Fluoride Toothpaste used for?

Super Strawberry Fluoride Toothpaste aids in the prevention of cavities.

What is the recommended amount for children under 3 years?

For children under 3 years, use no more than a tiny grain-of-rice smear.

What is the recommended amount for children between 3 and 6 years?

For children between 3 and 6 years, use only a pea-sized amount.

How should I use Super Strawberry Fluoride Toothpaste?

Place the product on a SuperMouth® toothbrush and brush teeth thoroughly at least twice a day for 2 minutes, or use as directed by a Dentist or Physician.

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

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

Are there any contraindications for using this toothpaste?

No contraindications are listed for Super Strawberry Fluoride Toothpaste.

Is this toothpaste safe for nursing mothers?

Nursing mothers should consult a healthcare professional before using this product, as there is a potential for excretion in breast milk.

What precautions should I take with children under 6 years?

Keep Super Strawberry Fluoride Toothpaste out of reach of children under 6 years of age.

Is there any information regarding the use of this toothpaste during pregnancy?

No specific information regarding the safety of this product during pregnancy is provided.

Packaging Info

Below are the non-prescription pack sizes of Super Strawberry (strawberry toothpaste). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Super Strawberry.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Super Strawberry Fluoride Toothpaste is a fluoride-based formulation designed for oral hygiene. This product is manufactured by SuperMouth and is presented in a net weight of 3.4 oz (96 g). The toothpaste features a super strawberry flavor, providing a unique taste experience. SuperMouth is located at 9737 Aero Drive, San Diego, CA 92123. For customer inquiries, the service line is available at (844) MOUTHCARE.

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

For children under 3 years of age, a dosage of no more than a tiny grain-of-rice smear is recommended. For children between 3 and 6 years, a pea-sized amount should be used.

The product should be applied to a SuperMouth® toothbrush, and teeth should be brushed thoroughly for at least 2 minutes, twice daily, or as directed by a Dentist or Physician. It is essential that caregivers supervise the child during brushing and rinsing to minimize the risk of swallowing the product.

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 of the situation.

While no specific instructions for discontinuation of use were provided, healthcare providers should remain vigilant and encourage patients to communicate any concerns or adverse effects experienced during the use of this product.

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 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 in the available 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 Super Strawberry (strawberry toothpaste). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Super Strawberry.
Details

Pediatric Use

Pediatric patients under 6 years of age should be kept out of reach of this product. For children under 3 years, a tiny grain-of-rice smear is recommended. For those between 3 and 6 years, a pea-sized amount should be used. The product should be applied to a SuperMouth® toothbrush, and teeth should be brushed thoroughly for at least 2 minutes, twice a day, or as directed by a Dentist or Physician. Caregivers are advised to supervise the child’s brushing and rinsing to minimize the risk of swallowing.

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.

Pregnancy

There is no specific information regarding the use of Super Strawberry Fluoride Toothpaste during pregnancy. As such, safety concerns, dosage modifications, or special precautions for pregnant patients have not been established. Healthcare professionals should consider the absence of data when advising women of childbearing potential and weigh the benefits against any potential risks when recommending this product during pregnancy.

Lactation

Lactating mothers should consult a healthcare professional before using this product. There is a potential for excretion in breast milk; therefore, caution is advised when administering to nursing mothers. The safety of this product during lactation has not been established.

Renal Impairment

There is no specific information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in 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, 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 related to the specific substance involved is essential, and appropriate management procedures should be initiated based on clinical judgment and established protocols.

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 available in the provided text.

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 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. Additionally, healthcare providers should remind patients to always follow the instructions provided on the label to ensure safe and effective use of the product.

Storage and Handling

The product is supplied in accordance with the specifications outlined on the label. It is essential to adhere to the provided instructions for optimal handling and storage.

Storage conditions must be strictly maintained within the recommended temperature range to ensure product integrity. Special handling requirements, if any, should be followed as indicated on the label.

Healthcare professionals are advised to consult the label for specific NDC numbers and packaging configurations relevant to the product.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Super Strawberry, 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 Super Strawberry, 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.