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Gleem

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This product has been discontinued

Active ingredient
Sodium Fluoride 1.5 mg/1 g
Other brand names
Dosage form
Paste, Dentifrice
Route
Dental
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2021
Label revision date
August 6, 2025
Active ingredient
Sodium Fluoride 1.5 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 2021
Label revision date
August 6, 2025
Manufacturer
Procter & Gamble Manfuacturing Company
Registration number
M021
NDC root
69423-907

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Drug Overview

GLEEM is a fluoride anticavity toothpaste designed to help protect your teeth against cavities. It contains charcoal powder, which is often associated with whitening effects, making it a popular choice for those looking to maintain a bright smile. With a net weight of 4.1 ounces (116 grams), GLEEM not only supports dental health but also enhances the appearance of your teeth.

Uses

You can use this product to help protect against 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.

Additionally, there are no concerns regarding teratogenic effects (which means it does not cause birth defects) or nonteratogenic effects (which refers to effects that do not cause harm during pregnancy) associated with this product. This makes it a safe option for many users.

Dosage and Administration

It's important to take care of your teeth, and brushing is a key part of that routine. If you are an adult or have a child who is 2 years or older, you should brush your teeth thoroughly after meals or at least twice a day. If your dentist has given you specific instructions, be sure to follow those as well. Remember, do not swallow the toothpaste. For children under 6, use only a pea-sized amount to help minimize the risk of swallowing.

If you have a child under 2 years old, it's best to consult with a dentist before using any toothpaste. Additionally, make sure to supervise your child's brushing until they develop good habits on their own. This way, you can help ensure they are brushing effectively and safely.

What to Avoid

It's important to 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.

While there are no specific contraindications or concerns about abuse, misuse, or dependence mentioned, always use the product as directed 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.

Always be cautious and ensure that this product is used safely to avoid any potential risks.

Warnings and Precautions

It's important to keep this product out of reach of children under 6 years old to ensure their safety. If a child accidentally swallows more than what is typically used for brushing, you should seek medical help or contact a Poison Control Center immediately.

Always use this product as directed. If you have any concerns or experience unusual symptoms, stop using it and call your doctor for 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 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

There is currently no specific information available about the use of GLEEM Whitening (sodium fluoride paste, dentifrice) during pregnancy. This means that safety concerns, dosage adjustments, or any special precautions for pregnant individuals have not been addressed in the drug insert.

If you are pregnant or planning to become pregnant, it’s important to consult with your healthcare provider before using this product. They can help you understand any potential risks and guide you on the best oral care practices during this time.

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. If your 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 help them brush their teeth thoroughly after meals or at least twice a day, following your dentist's advice.

To reduce the risk of swallowing, use only a pea-sized amount for children under 6. Always supervise their brushing until they develop good habits. If your child is under 2 years old, consult with a dentist before use.

Geriatric Use

While there is no specific information about the use of GLEEM Whitening (sodium fluoride paste, dentifrice) in older adults, it's always important to approach any new product with caution. If you are caring for an older adult, consider discussing the use of this toothpaste with their healthcare provider, especially if they have any existing health conditions or are taking other medications.

Since the drug insert does not mention any dosage adjustments or safety concerns for elderly patients, it’s wise to monitor for any unusual reactions or changes in oral health after starting the product. Always prioritize open communication with healthcare professionals to ensure the best care for older adults.

Renal Impairment

If you have kidney problems, it's important to know that there are no specific guidelines provided for dosage adjustments or monitoring related to renal impairment (kidney issues) for this medication. This means that the standard dosing may not be tailored for individuals with kidney concerns.

Always consult your healthcare provider for personalized advice and to ensure that your treatment plan is safe and effective, especially if you have any kidney-related conditions. They can help determine the best approach for your specific situation.

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 ensure that any treatment plan is safe and effective for your specific situation. They can help monitor your liver function and make any necessary adjustments to your care.

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 laboratory test interactions associated with the medication. 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. Your safety and well-being are the top priority, so don't hesitate to ask questions or share your concerns.

Storage and Handling

To ensure the best performance of your product, store it at room temperature, away from direct light. It's important to keep it in a safe place where it won't be exposed to freezing temperatures, as freezing can damage the product.

When handling the product, always do so with clean hands and in a clean environment to maintain its integrity. Following these simple guidelines will help you use the product safely and effectively.

Additional Information

This medication is administered through the dental route, meaning it is used in the mouth, typically for oral care. It's important to 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.

To ensure safety, do not swallow the product. 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 before use.

FAQ

What is GLEEM?

GLEEM is a fluoride anticavity toothpaste that helps protect against cavities.

What is the recommended usage for adults and children 2 years and older?

Brush your teeth thoroughly after meals or at least twice a day, or use as directed by a dentist. Do not swallow the toothpaste.

How should I use GLEEM for children under 6 years?

Use a pea-sized amount to minimize swallowing and supervise their brushing until good habits are established.

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

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

Are there any contraindications for GLEEM?

No contraindications are specified in the provided information.

Is GLEEM safe to use during pregnancy or while nursing?

There are no specific warnings or recommendations regarding the use of GLEEM during pregnancy or lactation.

How should GLEEM be stored?

Store at room temperature, protect from light, and do not freeze.

What are the teratogenic effects of GLEEM?

No teratogenic effects are mentioned for GLEEM.

What is the net weight of GLEEM?

GLEEM has a net weight of 4.1 ounces (116 grams).

Packaging Info

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

Packaging configurations for Gleem.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

GLEEM is a fluoride anticavity toothpaste formulated to provide whitening benefits. It contains charcoal powder, which is known for its adsorptive properties. The product is packaged in a net weight of 4.1 ounces (116 grams).

Uses and Indications

This drug is indicated for the protection against cavities.

There are no teratogenic effects associated with this drug. Additionally, no nonteratogenic effects have been reported.

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. It is important to ensure that the product is not swallowed during use. For children under the age of 6, a pea-sized amount should be used to minimize the risk of swallowing. Caregivers should supervise the brushing of teeth in children until proper oral hygiene habits are established.

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

Contraindications

Use is contraindicated in children under 6 years of age. Due to the potential risk of accidental ingestion, it is advised to keep this product out of reach of young children. In the event that more than the recommended amount for brushing is accidentally swallowed, seek medical assistance or contact a Poison Control Center immediately.

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

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

Packaging configurations for Gleem.
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 after meals or at least twice a day, or as directed by a dentist. To minimize swallowing, a pea-sized amount should be used for children under 6 years. Parents and caregivers are encouraged to supervise children's brushing until proper oral hygiene habits are established.

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

Geriatric Use

Elderly patients may not have specific dosage adjustments, safety concerns, or special precautions outlined in the drug insert for GLEEM Whitening (sodium fluoride paste, dentifrice). As there is no available information regarding the use of this product in geriatric populations, healthcare providers should exercise caution and consider individual patient factors when recommending this product to elderly patients. Monitoring for any adverse effects or unusual responses in this demographic is advisable, given the lack of targeted data.

Pregnancy

There is no specific information regarding the use of GLEEM Whitening (sodium fluoride paste, dentifrice) during pregnancy. The drug insert does not provide safety concerns, dosage modifications, or special precautions for pregnant patients. Therefore, healthcare professionals should exercise caution when recommending this product to women of childbearing potential and consider the absence of data when assessing the potential risks and benefits for pregnant patients.

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 prescribing information. There are no dosage adjustments, monitoring recommendations, or precautions outlined for individuals with reduced kidney function. Healthcare professionals should exercise clinical judgment when considering the use of this medication in patients with renal impairment, as the lack of specific guidance necessitates careful evaluation of individual patient circumstances.

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 supportive care and symptomatic treatment as necessary. It is advisable to provide the patient with information regarding the amount ingested and the time of ingestion to facilitate appropriate medical response.

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 have been reported for SPL code 90375-7.

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. 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 precaution is vital to ensure the safety and well-being of the patient.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at room temperature, ensuring that it is protected from light to maintain its integrity. Additionally, the product must not be frozen, as this could compromise its effectiveness. Proper handling and storage conditions are crucial for preserving the quality of the product.

Additional Clinical Information

The product is administered via the dental route. Clinicians should advise patients to keep the product 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 necessary. It is important to instruct caregivers not to allow children to swallow the product and to use only a pea-sized amount for children under 6 years. Supervision of children's brushing is recommended until proper habits are established, and for children under 2 years, consultation with a dentist is advised.

Drug Information (PDF)

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