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Opal by Opalescence Original

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Active ingredient
Sodium Fluoride 1.1 mg/1 g
Other brand names
Dosage form
Gel, Dentifrice
Route
Dental
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2023
Label revision date
June 17, 2025
Active ingredient
Sodium Fluoride 1.1 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 2023
Label revision date
June 17, 2025
Manufacturer
Ultradent Products, Inc.
Registration number
M021
NDC root
51206-312

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Drug Overview

Opal™ by Opalescence® is a whitening toothpaste that comes in a refreshing cool mint flavor and contains fluoride. This toothpaste is designed to help you achieve a brighter smile while also aiding in the prevention of dental decay.

By incorporating fluoride, Opal™ not only works to whiten your teeth but also strengthens them, making it a beneficial addition to your daily oral care routine.

Uses

You can use this medication 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 cavities. 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, ideally after each meal or at least twice a day. This applies to both adults and children aged 2 years and older. If you have children under 6, make sure to teach them proper brushing and rinsing techniques to help prevent swallowing toothpaste. You should supervise them while they brush until they can do it on their own.

If your child is under 2 years old, it's best to consult a dentist or doctor for guidance on how to care for their teeth. Following these recommendations will help ensure good dental hygiene 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.

By following these guidelines, you can help ensure the safe use of this product.

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.

Always be aware of how to use this product safely to avoid any potential risks.

Warnings and Precautions

It's important to keep this product out of the reach of children under 6 years old 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 if you have any concerns or experience unusual symptoms, don’t hesitate to stop using it and call your doctor for advice. Your safety is a priority, so please take these precautions seriously.

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

When considering the use of Opal by Opalescence Original (sodium fluoride gel, dentifrice) during pregnancy, it's important to note that there is no specific information available about its safety, dosage adjustments, or any special precautions for pregnant individuals. This means that the effects of this product on pregnancy have not been clearly studied or established.

If you are pregnant or planning to become pregnant, it’s always best to consult with your healthcare provider before using any new products, including dental care items like this fluoride gel. They can provide personalized advice based on your health needs and circumstances.

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 are no particular considerations or precautions mentioned for lactation (the process of producing milk) in the information provided. This suggests that the product is generally considered safe for use during breastfeeding. However, it's always a good idea to consult with your healthcare provider if you have any concerns or questions about medications while nursing.

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 typically used for brushing, seek medical help or contact a Poison Control Center immediately. 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 guidance of a dentist or doctor.

For children under 6, make sure to teach them proper brushing and rinsing techniques to help prevent swallowing the product. Always supervise younger children while they brush their teeth until they are able to do so independently. If your child is under 2 years old, it's best to consult with a dentist or doctor before use.

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, it’s important to consult with a healthcare provider before starting the medication. 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 your treatment plan is safe and effective for your specific health needs. They can provide guidance based on your kidney function and overall 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 may affect you if you have hepatic impairment (issues with liver function).

Always consult your healthcare provider for personalized advice and to discuss any concerns 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 you are taking. In this case, there are no specific drug interactions or laboratory test interactions noted, which means that the medication is generally considered safe to use with other drugs and tests. However, every individual is different, and your healthcare provider can help ensure that your treatment plan is safe and effective for you.

Always remember that discussing your full list of medications and any lab tests with your healthcare provider is crucial. This way, you can avoid any potential issues and receive the best care tailored to your needs.

Storage and Handling

To ensure the safety and effectiveness of your product, always check that the tamper-evident seal is intact before use. If the seal is broken, do not use the product. For proper storage, keep it at room temperature, away from extreme heat or cold. This will help maintain its quality and performance.

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 opal™ by Opalescence®?

Opal™ by Opalescence® is a whitening toothpaste that comes in a cool mint flavor and contains fluoride. It is designed to aid in the prevention of dental decay.

Who can use opal™ toothpaste?

Adults and children 2 years of age and older can use opal™ toothpaste. Children under 2 years should consult a dentist or doctor before use.

How should I use opal™ toothpaste?

Brush your teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor. Supervise children under 6 years of age during brushing.

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 opal™ toothpaste?

No specific contraindications are listed for opal™ toothpaste.

Is there any information about using opal™ during pregnancy or lactation?

There are no specific warnings or recommendations regarding the use of opal™ by pregnant or nursing mothers.

How should I store opal™ toothpaste?

Store opal™ toothpaste at room temperature and do not use it if the tamper-evident seal is broken.

Are there any known drug interactions with opal™ toothpaste?

No specific drug interactions are mentioned for opal™ toothpaste.

Packaging Info

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

Packaging configurations for Opal by Opalescence Original.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

opal™ by Opalescence® is a whitening toothpaste formulated with fluoride. It is presented in a net weight of 4.7 ounces and features an original cool mint flavor. The product is designed to enhance dental aesthetics while providing the protective benefits of fluoride.

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 should brush their teeth thoroughly, preferably after each meal or at least twice daily, or as directed by a dentist or doctor. It is important to instruct children under 6 years of age in proper brushing and rinsing techniques to minimize the risk of swallowing. Caregivers should supervise children as necessary until they are capable of brushing without assistance.

For children under 2 years of age, it is recommended to consult a dentist or doctor for appropriate guidance on dental care.

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 should be sought 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 used 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

There are no specific drug interactions or laboratory test interactions identified in the available data. Therefore, no recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

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

Packaging configurations for Opal by Opalescence Original.
Details

Pediatric Use

Pediatric patients under 6 years of age should be kept out of reach of the 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.

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 doctor. Caregivers should instruct children under 6 years in proper brushing and rinsing techniques to minimize the risk of swallowing the product. Supervision is necessary until children are capable of brushing without assistance.

For infants and children under 2 years of age, consultation with a dentist or doctor is recommended prior to use.

Geriatric Use

There is no specific information available 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 available regarding the use of Opal by Opalescence Original (sodium fluoride gel, dentifrice) during pregnancy. As such, the safety of this product in pregnant patients has not been established, and there are no known dosage modifications or special precautions recommended for use during this period. Healthcare professionals should consider the lack of data when advising women of childbearing potential and weigh the potential benefits against any unknown risks to fetal outcomes.

Lactation

There are no specific warnings or recommendations regarding the use of this product by lactating mothers. Additionally, there are no specific considerations or precautions mentioned related to lactation. Breastfed infants are not expected to be affected adversely based on the available information.

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 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 any adverse effects is recommended.

Management procedures should include supportive care and symptomatic treatment as necessary. It is advisable to have the product's labeling and any relevant patient information readily available when contacting medical professionals or poison control for guidance.

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 question. Further studies may be necessary to fully evaluate the nonclinical toxicology profile.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this product out of the 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 used for brushing is accidentally swallowed, healthcare providers should instruct patients to seek medical help or contact a Poison Control Center immediately. This guidance is crucial for ensuring patient safety and prompt response in case of an emergency.

Storage and Handling

The product is supplied in packaging that includes a tamper-evident seal. It is imperative that the product not be used if this seal is broken, as this may indicate potential contamination or compromise of the product's integrity.

For optimal storage, the product should be maintained at room temperature. Care should be taken to ensure that the storage environment is stable and free from extreme temperature fluctuations to preserve the product's efficacy and safety.

Additional Clinical Information

The route of administration for the product is dental. There are no additional details available regarding laboratory tests, abuse information, patient counseling information, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Opal by Opalescence Original, 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 Opal by Opalescence Original, 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.

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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.