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Orajel

Last content change checked dailysee data sync status

This product has been discontinued

Active ingredient
Sodium Fluoride 1.5 mg/1 g
Other brand names
Dosage form
Gel, Dentifrice
Route
Dental
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2018
Label revision date
November 27, 2024
Active ingredient
Sodium Fluoride 1.5 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 2018
Label revision date
November 27, 2024
Manufacturer
Church & Dwight Co. , Inc.
Registration number
M021
NDC root
10237-775

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Drug Overview

JURASSIC WORLD is a fluoride-based toothpaste designed specifically for children aged 2 to 10 years. This anti-cavity toothpaste helps in the prevention of dental decay, making it an important part of your child's oral hygiene routine. With a fun natural berry blast flavor, it encourages kids to brush their teeth while also supporting their dental health.

Additionally, JURASSIC WORLD is packaged in a plastic tube and is committed to environmentally friendly practices, being a certified renewable energy product and a proud supporter of the Arbor Day Foundation.

Uses

You can use this product to help prevent dental decay, which is the process that leads to cavities in your teeth. By incorporating it into your oral care routine, you can support your dental health and reduce the risk of developing issues related to tooth decay. 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 them thoroughly after meals or at least twice a day. This applies to both adults and children aged 2 years and older. If you have any specific instructions from your dentist or physician, be sure to follow those as well.

For children under 6 years old, it's essential to teach them good brushing and rinsing habits to help minimize the chance of swallowing toothpaste. If your child is under 2 years old, it's best to consult with a dentist or physician for guidance on how to care for their teeth properly.

What to Avoid

It's important to ensure that any medication you use is kept safe and secure. Specifically, you should keep this medication out of reach of children under 6 years of age to prevent any accidental ingestion or misuse.

Currently, there are no specific contraindications, controlled substance classifications, or concerns regarding abuse or dependence associated with this medication. However, always consult with your healthcare provider if you have any questions or concerns about its use.

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 immediately. This is a serious situation that requires prompt attention to ensure your safety. Always use the product as directed to avoid any potential risks.

Warnings and Precautions

If you accidentally swallow more of this product than intended 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.

Always use this product as directed to avoid any potential risks. If you have any concerns or experience unusual symptoms, don’t hesitate to stop using it and call your doctor for advice. Your health and well-being are the top priority.

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 about the safety or use of this medication during pregnancy. This means that there are no established guidelines regarding dosage adjustments or special precautions for pregnant individuals.

Given this lack of information, it's 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

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding the use of this product while nursing. Additionally, there is no information available about whether this product is excreted in breast milk or any potential risks to your infant. Always consult with your healthcare provider if you have any concerns or questions about medications while breastfeeding.

Pediatric Use

It's important to keep this product out of reach of children under 6 years old. For children in this age group, you should supervise their use until they can handle it safely on their own. If your child is 2 years or older, encourage them to brush their teeth thoroughly after meals or at least twice a day, following any specific instructions from their dentist or physician.

For children under 6, make sure to teach them good brushing and rinsing habits to help prevent swallowing the product. 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. Since older adults may have different health needs and responses to medications, you should always consult with a healthcare provider before starting any new medication. They can help determine the right dosage and monitor for any potential side effects or interactions with other treatments you may be using.

Remember, your health and safety are the top priority, so don’t hesitate to ask questions and discuss any concerns with your doctor or pharmacist.

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.

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe and appropriate for your kidney health. They can help you understand how your condition may affect your treatment plan.

Hepatic Impairment

If you have liver 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 apply, but you should always consult your healthcare provider for personalized advice. They can help determine the best approach for your treatment and monitor your liver function as needed.

Make sure to keep your doctor informed about your liver health, as they may want to conduct regular tests to ensure your safety while using any medication. Your well-being is a priority, so don't hesitate to ask questions or express any concerns you may have.

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 interactions with other drugs or laboratory tests. However, always ensure that your healthcare provider is aware of all the medications you are using, as they can help monitor your health and adjust treatments if necessary. This way, you can avoid any potential issues and ensure 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 and protect it from freezing. It's important to keep the tube tightly closed when not in use to maintain its integrity. Additionally, remember to discard any unused product after the expiration date to ensure safety and effectiveness. Following these guidelines will help you handle the product safely and effectively.

Additional Information

You should use this product by applying it directly to your teeth as directed by your dentist or physician. For adults and children aged 2 years and older, it's recommended to brush your teeth thoroughly after meals or at least twice a day. If you have children under 6 years old, make sure to teach them good brushing and rinsing habits to help prevent swallowing the product. For children under 2 years, consult with a dentist or physician before use.

FAQ

What is JURASSIC WORLD?

JURASSIC WORLD is an Orajel™ kids anti-cavity toothpaste that aids in the prevention of dental decay.

What age range is JURASSIC WORLD suitable for?

JURASSIC WORLD is suitable for children aged 2 to 10 years.

How should I use JURASSIC WORLD?

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

What should I instruct children under 6 years when using JURASSIC WORLD?

Instruct children under 6 years in good brushing and rinsing habits to minimize swallowing.

What should I do if a child under 2 years needs to use JURASSIC WORLD?

For children under 2 years, ask a dentist or physician before use.

Are there any contraindications for JURASSIC WORLD?

No contraindications are listed for JURASSIC WORLD.

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.

How should I store JURASSIC WORLD?

Store JURASSIC WORLD at room temperature, protect it from freezing, and keep the tube tightly closed when not in use.

Is there any information regarding the use of JURASSIC WORLD during pregnancy or lactation?

There is no specific information provided regarding the use of JURASSIC WORLD during pregnancy or lactation.

What is the flavor of JURASSIC WORLD?

JURASSIC WORLD has a natural berry blast flavor.

Packaging Info

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

Packaging configurations for Orajel.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

JURASSIC WORLD is a Stage 3 anti-cavity toothpaste specifically formulated for children aged 2 to 10 years. This product contains fluoride and is naturally sourced, providing a Natural Berry Blast flavor. The toothpaste is packaged in a plastic tube with a net weight of 4.2 ounces (119 grams). For recycling information, refer to how2recycle.info.

Uses and Indications

This drug is indicated for the prevention of dental decay. It is intended for use in individuals at risk of developing dental caries.

Dosage and Administration

Adults and children aged 2 years and older are advised to brush their teeth thoroughly after meals or at least twice daily, or as directed by a dentist or physician.

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

For children under 2 years, consultation with a dentist or physician is recommended prior to use.

Contraindications

Use is contraindicated in children under 6 years of age. This precaution is necessary to prevent potential harm due to the product's formulation or effects in this age group.

Warnings and Precautions

In the event of accidental ingestion of an amount exceeding that typically used for brushing, immediate medical assistance should be sought. Healthcare professionals are advised to contact a Poison Control Center without delay to ensure appropriate management and intervention.

Side Effects

Patients should be aware that if 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. This warning highlights the potential seriousness of accidental ingestion and underscores the importance of adhering to the recommended usage guidelines to ensure safety.

Drug Interactions

No drug interactions have been identified for the product, indicating that it does not have any known pharmacodynamic or pharmacokinetic interactions with other medications. Additionally, there are no reported interactions with 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 Orajel (sodium fluoride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Orajel.
Details

Pediatric Use

Pediatric patients under 6 years of age should be kept out of reach of the product. It is recommended that children be supervised during use until they are capable of using the product without assistance. For children aged 2 years and older, it is advised to brush teeth thoroughly after meals or at least twice a day, or to use the product as directed by a dentist or physician.

For children under 6 years, caregivers should instruct them in proper brushing and rinsing techniques to minimize the risk of swallowing. For infants and children under 2 years, consultation with a dentist or physician is recommended prior to use.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any potential 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

There are no specific warnings or recommendations regarding the use of this product by lactating mothers. Additionally, there is no information available about the potential for excretion in breast milk or any associated risks to breastfed infants.

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

Management procedures should include assessing the patient's condition and providing supportive care as necessary. It is advisable to follow established protocols for the treatment of overdosage, which may involve symptomatic treatment and monitoring of vital signs.

In all cases of suspected overdosage, the involvement of poison control and emergency medical services is crucial to ensure appropriate care and intervention.

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 compound in these areas.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of the reach of children under 6 years of age. It is important to emphasize the potential risks associated with accidental ingestion by young children and to encourage patients to store the medication in a secure location.

Storage and Handling

The product is supplied in a tube format, with specific handling and storage requirements to ensure its integrity and efficacy. It should be stored at room temperature, away from extreme temperatures, and must be protected from freezing. To maintain the quality of the product, the tube should be kept tightly closed when not in use. Additionally, any unused product should be discarded after the expiration date to ensure safety and effectiveness.

Additional Clinical Information

The product is administered via the dental route. For adults and children aged 2 years and older, it is recommended to brush teeth thoroughly after meals or at least twice daily, or as directed by a dentist or physician. For children under 6 years, caregivers should instruct them in proper brushing and rinsing techniques to minimize swallowing. For children under 2 years, consultation with a dentist or physician is advised prior to use.

No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences.

Drug Information (PDF)

This file contains official product information for Orajel, 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 Orajel, 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

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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.