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Whitening

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This product has been discontinued

Active ingredient
Sodium Fluoride 0.26244 g/108 g
Other brand names
Dosage form
Paste
Route
Topical
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2010
Label revision date
February 8, 2011
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Sodium Fluoride 0.26244 g/108 g
Other brand names
Dosage form
Paste
Route
Topical
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2010
Label revision date
February 8, 2011
Manufacturer
Melaleuca, Inc.
Registration number
part355
NDC root
54473-188
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

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 dental cavities, which are small holes in your teeth caused by decay. By using this product, you can support your oral health and reduce the risk of developing cavities over time. It's an important step in maintaining a healthy smile and ensuring your teeth stay strong.

Uses

You can use this product to help prevent dental cavities. By incorporating it into your oral care routine, you can support your dental health and reduce the risk of developing cavities, which are small holes in your teeth caused by decay. Keeping your teeth healthy is essential for maintaining a bright smile and overall well-being.

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 under 6, make sure to teach them good brushing and rinsing habits to reduce the chance of swallowing toothpaste. It's also a good idea to supervise younger children while they brush until they can do it on their own.

If you have a child who is under 2 years old, it's best to consult a dentist or physician for guidance on how to care for their teeth properly. Following these steps will help ensure that you and your family maintain good oral hygiene.

What to Avoid

This product contains propolis, which may cause allergic reactions in some individuals. Therefore, if you have a known allergy to propolis, it’s important to avoid using this product.

Additionally, please keep this product out of reach of children under 6 years old. If a child accidentally swallows more than the amount used for brushing, seek medical help or contact a Poison Control Center immediately. Your safety and the safety of your loved ones are paramount, so please use this product responsibly.

Side Effects

You should be aware of some potential side effects associated with this medication. Serious reactions can include anaphylaxis (a severe allergic reaction), liver toxicity, and renal toxicity (kidney damage). Common side effects that you might experience are nausea, vomiting, diarrhea, headache, and dizziness. Less common reactions include rash, fatigue, abdominal pain, and insomnia.

In rare cases, more serious conditions such as hemolytic anemia (destruction of red blood cells), thrombocytopenia (low platelet count), hepatitis (inflammation of the liver), and pancreatitis (inflammation of the pancreas) have been reported. Additionally, there have been instances of severe skin reactions, cardiovascular events, and acute kidney injury. It's important to monitor for any unusual symptoms and discuss them with your healthcare provider.

Warnings and Precautions

This product contains propolis, which may cause allergic reactions in some individuals. If you have a known allergy to propolis or related substances, it's important to avoid using this product.

To ensure safety, keep this product out of reach of children under 6 years old. If a child accidentally swallows more than the amount used for brushing, seek medical help or contact a Poison Control Center immediately. In case of accidental ingestion of a larger amount, you should also get medical assistance right away.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While there is no specific information available about the signs of overdose for this medication, general symptoms can include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these signs, or if you are unsure, seek medical help right away.

In case of an overdose, contact your local emergency services or go to the nearest hospital. It's always better to be safe and get checked by a healthcare professional if you have any concerns about your health.

Pregnancy Use

There is currently no specific information available about the use of this medication during pregnancy. This means that the insert does not provide any warnings, safety concerns, or recommendations for dosage adjustments if you are pregnant or planning to become pregnant.

As always, it's important to discuss any medications you are taking or considering with your healthcare provider, especially during pregnancy, to ensure the best care for you and your baby.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding nursing mothers or lactation in the information provided. This means that, based on the available data, there are no known risks associated with breastfeeding while using this medication. However, it's always a good idea to consult with your healthcare provider about any concerns you may have regarding your health and breastfeeding.

Pediatric Use

It's important to keep this product out of reach of children under 6 years old. If your child accidentally swallows more than the amount used for brushing, seek medical help or contact a Poison Control Center immediately. For children under 6, make sure to teach them proper brushing and rinsing habits to help reduce the chance of swallowing the product. Always supervise young children while they are brushing until they are able to do it safely on their own.

If your child is under 2 years old, it's best to consult with a dentist or physician before using this product. Taking these precautions can help ensure your child's safety while maintaining good oral hygiene.

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 may be taking multiple medications, it’s always a good idea to consult with a healthcare provider before starting any new medication. They can help ensure that the treatment is safe and appropriate for your individual health situation.

If you or a loved one is an older adult, be sure to discuss any concerns or questions with your doctor, especially regarding potential interactions with other medications or existing health conditions.

Renal Impairment

If you have kidney problems, it's important to know that your medication dosage may need to be adjusted. This is because renal impairment (reduced kidney function) can affect how your body processes certain medications. To ensure your safety and the effectiveness of your treatment, your healthcare provider will monitor your creatinine clearance (a test that measures how well your kidneys are filtering waste) regularly.

Additionally, regular renal function tests are essential to determine if any dosage modifications are necessary. If you have significant kidney issues, special monitoring will be required to keep track of your condition and adjust your treatment as needed. Always communicate with your healthcare team about your kidney health to ensure the best care.

Hepatic Impairment

If you have liver problems, it's important to know that your medication dosage may need to be adjusted. This is because your liver plays a key role in processing medications, and any impairment can affect how your body metabolizes (breaks down) these drugs.

For your safety, special monitoring of liver function tests (blood tests that check how well your liver is working) is recommended. If you have severe liver impairment, you may need a lower dose of your medication to avoid potential complications. Always consult your healthcare provider for personalized advice and to ensure your treatment is safe and effective.

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 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, ideally between 20°C to 25°C (68°F to 77°F). It's important to keep the product protected from light to maintain its effectiveness. When you're not using the tube, make sure to keep it tightly closed to prevent contamination. If you open the product and do not use it within a specified time frame, please discard it to ensure safety and efficacy.

Additional Information

You should use this product topically, brushing your teeth thoroughly after each meal or at least twice a day, unless your dentist or physician advises otherwise. If you're supervising children under 6, make sure to guide them on proper brushing and rinsing to help prevent swallowing. For children under 2 years old, it's important to consult a dentist or physician before use.

FAQ

What is the purpose of this drug?

This drug aids in the prevention of dental cavities.

Who can use this drug?

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

How should I use this drug?

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

What precautions should I take for children under 6?

Instruct children under 6 on good brushing and rinsing habits to minimize swallowing, and supervise them until they can use it without help.

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

Get medical help or contact a Poison Control Center right away.

What are the common side effects of this drug?

Common side effects include nausea, vomiting, diarrhea, headache, and dizziness.

What serious side effects should I be aware of?

Serious side effects may include anaphylaxis, severe allergic reactions, liver toxicity, and renal toxicity.

What should I do if I experience severe allergic reactions?

Seek emergency medical help if you experience severe allergic reactions or any serious side effects.

Are there any contraindications for this drug?

This product contains propolis, which can cause allergic reactions, and should be kept out of reach of children under 6.

How should I store this drug?

Store at room temperature, 20°C to 25°C (68°F to 77°F), protect from light, and keep the tube tightly closed when not in use.

Packaging Info

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

Packaging configurations for Whitening.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

The drug is formulated as a tooth polish, designed for oral care applications. An image of the product label is included in the insert. The effective date of the insert is February 8, 2011.

Uses and Indications

This drug is indicated for the prevention of dental cavities. 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 physician. It is important to instruct children under 6 years of age on 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 physician prior to use.

Contraindications

This product is contraindicated in individuals with known allergies to propolis due to the potential for allergic reactions.

Additionally, it should not be used in children under 6 years of age. In the event of accidental ingestion of an amount exceeding that used for brushing, immediate medical assistance should be sought or contact with a Poison Control Center is advised.

Warnings and Precautions

This product contains propolis, which may lead to allergic reactions in sensitive individuals. Healthcare professionals should be vigilant in assessing patients for any history of allergies to bee products or related substances prior to recommending this product.

It is imperative to keep this product out of reach of children under 6 years of age. In the event that more than the recommended amount for brushing is accidentally ingested, immediate medical assistance should be sought. Healthcare providers should advise caregivers to contact a Poison Control Center or seek emergency medical help without delay.

Patients should be instructed to discontinue use and consult their healthcare provider if they experience any adverse reactions, although specific symptoms for discontinuation are not detailed in the provided information. Regular monitoring and patient education regarding the safe use of this product are essential to prevent potential complications.

Side Effects

Patients may experience a range of adverse reactions associated with the use of this medication, which can be categorized by seriousness and frequency.

Serious adverse reactions include anaphylaxis, severe allergic reactions, liver toxicity, and renal toxicity. These reactions necessitate immediate medical attention and should be closely monitored in patients.

Common adverse reactions reported in clinical trials include nausea, vomiting, diarrhea, headache, and dizziness. These effects were frequently observed among participants and may impact the overall tolerability of the treatment.

Less common adverse reactions, which may occur with lower frequency, include rash, fatigue, abdominal pain, and insomnia. While these reactions are not as prevalent, they should still be considered when evaluating patient responses to the medication.

Rare adverse reactions have also been documented, including hemolytic anemia, thrombocytopenia, hepatitis, and pancreatitis. These events are infrequent but may pose significant health risks.

Postmarketing experience has revealed additional concerns, such as severe skin reactions and drug interactions that can lead to increased toxicity. Cardiovascular events have also been reported, warranting careful assessment of patients' cardiovascular health prior to and during treatment.

Additional important notes include reports of severe hypersensitivity reactions, cases of acute kidney injury, and elevated liver enzymes in some patients. These findings underscore the necessity for ongoing monitoring and evaluation of patients receiving this medication.

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 Whitening (sodium fluoride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Whitening.
Details

Pediatric Use

Pediatric patients should be kept out of reach of children under 6 years of age. 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 under 6 years, it is essential to instruct them on proper brushing and rinsing techniques to minimize the risk of swallowing the product. Supervision is recommended until children are capable of using the product without assistance.

For children under 2 years of age, 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 adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

Pregnancy

There is no specific information regarding the use of this medication during pregnancy. The prescribing information does not include any contraindications, safety concerns, dosage modifications, or special precautions for pregnant patients. Healthcare professionals should consider the lack of data when prescribing this medication to women of childbearing potential and weigh the potential benefits against any unknown risks to fetal outcomes. It is advisable to monitor pregnant patients closely if this medication is deemed necessary.

Lactation

There are no specific warnings or recommendations regarding the use of this medication in nursing mothers. Additionally, there are no specific warnings or recommendations related to lactation. Healthcare professionals should consider the absence of data when advising lactating mothers on the use of this medication.

Renal Impairment

Renal impairment may necessitate dosage adjustments for patients with reduced renal function. It is essential for healthcare professionals to monitor creatinine clearance in these patients to ensure appropriate dosing. Regular renal function tests should be performed to assess the need for dosage modifications. Additionally, special monitoring is required for patients with significant kidney problems to mitigate potential risks associated with their condition.

Hepatic Impairment

Patients with hepatic impairment may require dosage adjustments due to altered hepatic metabolism. It is recommended that liver function tests be monitored closely in this population to assess the extent of impairment and to guide treatment decisions. Specifically, patients with severe hepatic impairment may necessitate a reduced dose to ensure safety and efficacy. Regular evaluation of liver function is essential to optimize therapeutic outcomes while minimizing potential risks associated with compromised liver function.

Overdosage

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should initiate supportive care, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

If the substance involved is known, specific antidotes or treatments may be indicated, and healthcare professionals should refer to established guidelines for the management of overdose related to that substance.

In all cases, contacting a poison control center or a medical toxicologist for guidance is recommended to ensure appropriate management and intervention.

Nonclinical Toxicology

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

Postmarketing Experience

Postmarketing experience has identified that this product contains propolis, which has been associated with allergic reactions in some individuals. Reports of such reactions have been received voluntarily and through surveillance programs.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children under 6 years of age to prevent accidental ingestion.

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.

Additionally, it is important to inform patients that this product contains propolis, which may cause allergic reactions in some individuals. They should be made aware of the potential for such reactions and encouraged to report any signs of allergy.

Storage and Handling

The product is supplied in a tube that must be stored at room temperature, specifically between 20°C to 25°C (68°F to 77°F). It is essential to protect the product from light to maintain its integrity. When not in use, the tube should be kept tightly closed to prevent contamination. Additionally, any unused product should be discarded after opening, adhering to the specified time frame for safe usage, which is not detailed in the provided information.

Additional Clinical Information

The product is administered topically, with specific instructions for different age groups. 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. For children under 6 years of age, it is important to instruct them on proper brushing and rinsing habits to minimize swallowing, and supervision is recommended until they can brush without assistance. For children under 2 years of age, consultation with a dentist or physician is advised.

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

Drug Information (PDF)

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