ADD CONDITION

items per page

Dinosaur

Last content change checked dailysee data sync status

This product has been discontinued

Active ingredient
Sodium Fluoride 100 mg/100 g
Other brand names
Dosage form
Paste
Route
Dental
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2021
Label revision date
May 1, 2021
Active ingredient
Sodium Fluoride 100 mg/100 g
Other brand names
Dosage form
Paste
Route
Dental
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2021
Label revision date
May 1, 2021
Manufacturer
LMZ
Registration number
part356
NDC root
71775-070

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

This medication is designed to help prevent cavities, which are small holes in your teeth caused by decay. By using this product, you can support your dental health and reduce the risk of developing cavities over time. It's a simple step you can take to maintain a healthy smile.

Uses

You can use this product 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 dental issues. Regular use can be an effective way to maintain a 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. If you're helping a child under 6 years old, use only a pea-sized amount of toothpaste to minimize the chance of swallowing. Always supervise young children while they brush their teeth until they develop good habits.

If you have a child under 2 years old, it's best to consult with a dentist or physician before starting any dental care routine. Remember, do not swallow the toothpaste, as it's meant for cleaning your teeth, not for ingestion. Following these guidelines will help ensure you and your family maintain good oral hygiene.

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

If you accidentally swallow more of this product than intended for brushing, it’s important to seek medical help or contact a Poison Control Center right away. This is a serious situation, and prompt action is necessary to ensure your safety. Always use the product as directed to avoid any potential risks.

Warnings and Precautions

If you accidentally swallow more than the amount 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.

Always use the product as directed to avoid any potential risks. If you experience any unusual symptoms or reactions, stop using the product and call your doctor for further advice. Your health and safety are the top priority, so don’t hesitate to reach out for help if needed.

Overdose

If you accidentally swallow more of the medication than what is typically used for brushing your teeth, it’s important to seek medical help right away. You can also contact a Poison Control Center for guidance.

Signs of an overdose may not be immediately obvious, but it’s crucial to act quickly. If you notice any unusual symptoms or feel unwell after swallowing too much, don’t hesitate to get help. Remember, it’s always better to be safe and get checked by a healthcare professional.

Pregnancy Use

When it comes to using this medication during pregnancy, there is no specific information available about its safety, dosage adjustments, or any special precautions you should take. This means that the effects of the medication on you and your developing baby are not well understood.

If you are pregnant or planning to become pregnant, it’s important to discuss any medications you are taking with your healthcare provider. They can help you weigh the potential risks and benefits to ensure the best care 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 it could potentially affect your baby. Since the effects on nursing infants have not been thoroughly studied, it's best to exercise caution. Always prioritize your health and your baby's well-being by seeking professional advice.

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 encourage them to brush their teeth thoroughly, ideally after each meal or at least twice a day, following the advice of a dentist or physician. When helping younger children, use only a pea-sized amount to minimize the risk of swallowing.

Make sure to 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

While there is no specific information available about the use of this medication in older adults, it’s important to approach any new treatment with caution. If you or a loved one is an older adult, it’s always wise to discuss any medications with a healthcare provider, especially since older adults may have different health needs and may be taking multiple medications.

Since there are no dosage adjustments or special precautions mentioned for elderly patients, your healthcare provider can help determine the best approach based on individual health conditions and overall treatment goals. Always prioritize open communication with your doctor to ensure safe and effective use of any medication.

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 you understand any necessary precautions or adjustments based on your kidney health.

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

Drug Interactions

It's great to know that there are no reported 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 may 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 avoid freezing it. It's important to keep the tube tightly closed when not in use to maintain its integrity. If you notice that the inner foil is torn, cut, or missing after opening, please discard the product to ensure your safety. Following these guidelines will help you use the product effectively and safely.

Additional Information

This product is administered through the dental route, meaning it is used in the mouth for oral care. It's important to follow some safety guidelines: if you accidentally swallow more than what is needed for brushing, seek medical help or contact a Poison Control Center right away. Keep this product out of reach of children under 6 years old, and do not swallow it. 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.

FAQ

What is the purpose of this product?

This product aids in the prevention of cavities.

Who can use this product?

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

How should I use this product?

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

What should I do if I accidentally swallow this product?

If you accidentally swallow more than used for brushing, get medical help or contact a Poison Control Center immediately.

Are there any contraindications for this product?

No contraindications are listed for this product.

What precautions should I take for children using this product?

Supervise children's brushing until good habits are established, and use a pea-sized amount to minimize swallowing in children under 6 years.

What should I do if the inner foil is torn or missing?

Do not use the product if the inner foil is torn, cut, or missing.

Is this product 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.

How should I store this product?

Store at room temperature, do not freeze, and keep the tube tightly closed when not in use.

Packaging Info

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

Packaging configurations for Dinosaur.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

The product is available in two dosage forms: 24 grams and 120 grams. The 24-gram formulation is identified by the National Drug Code (NDC) numbers 71775-070-54, 71775-070-55, and the 120-gram formulation is identified by the NDC numbers 71775-070-52, 71775-070-53. The active ingredient is specified as 24,000 mg of Dinosaur in the 24-gram formulation and 120,000 mg of Dinosaur in the 120-gram formulation. Additionally, the product is associated with the designation "Great Shark" for the 24-gram version and "Shark" for the 120-gram version.

Uses and Indications

This drug is indicated for the prevention of dental cavities. It is intended for use in individuals at risk of developing cavities, including children and adults. Regular use of this drug may contribute to improved oral health by reducing the incidence of 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 should be used to minimize the risk of swallowing. Caregivers should supervise the brushing of children 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.

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

In the event of accidental ingestion of an amount exceeding that typically used for brushing, it is imperative to seek immediate medical assistance or contact a Poison Control Center. Prompt action is essential to mitigate potential health risks associated with excessive consumption. Healthcare professionals should advise patients on the importance of adhering to recommended usage guidelines to prevent such occurrences.

Side Effects

Patients should be aware of the potential risks associated with the use of this product. In the event of accidental ingestion of more than the recommended amount for brushing, it is imperative to seek medical assistance or contact a Poison Control Center immediately. This warning highlights the seriousness of the situation and underscores the importance of adhering to the recommended usage guidelines to prevent adverse outcomes.

Drug Interactions

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

Packaging & NDC

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

Packaging configurations for Dinosaur.
Details

Pediatric Use

Pediatric patients under 6 years of age should be kept out of reach of the product. For children aged 2 years and older, it is recommended to brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician. To minimize the risk of swallowing, a pea-sized amount should be used for children under 6 years. It is important to supervise children's brushing until good oral hygiene habits are established. For children under 2 years of age, 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. 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

There is no specific information available 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. It is advisable to weigh the potential benefits against any unknown risks to fetal outcomes. Women of childbearing potential should be counseled on the importance of effective contraception during treatment.

Lactation

Lactating mothers should consult a healthcare professional before using this product. There is a potential for excretion in breast milk, and the effects on nursing infants are not well studied; therefore, caution is advised.

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 imperative that immediate medical assistance is sought. If an individual accidentally ingests more than the recommended amount used for brushing, it is crucial to contact a healthcare professional or reach out to a Poison Control Center without delay.

Healthcare providers should be aware of the potential risks associated with overdosage and ensure that patients are informed about the importance of adhering to the recommended usage guidelines. Prompt intervention can mitigate adverse effects and facilitate appropriate management of the situation.

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 understanding of potential risks associated with the compound in nonclinical settings.

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 under 6 years of age to prevent accidental ingestion. It is important to emphasize that the medication should not be used if the inner foil is torn, cut, or missing, as this may compromise the integrity of the product. Patients should be encouraged to inspect the packaging carefully before use and to report any concerns regarding the condition of the packaging to their healthcare provider.

Storage and Handling

The product is supplied in a tube that must be stored at room temperature. It is essential to avoid freezing the product to maintain its integrity. When not in use, the tube should be kept tightly closed to prevent contamination and degradation. Additionally, if the inner foil is torn, cut, or missing after opening, 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 seek medical help or contact a Poison Control Center immediately if more than the recommended amount for brushing is accidentally swallowed. It is crucial to keep the product out of reach of children under 6 years of age and to instruct caregivers not to allow swallowing. For children under 6, a pea-sized amount should be used, and supervision during brushing is recommended until proper habits are established. Additionally, for children under 2 years of age, consultation with a dentist or physician is advised.

Drug Information (PDF)

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