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Spry Dentifrice

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Active ingredient
Sodium Fluoride 2.43 mg/1 g
Other brand names
Dosage form
Paste, Dentifrice
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2017
Label revision date
November 11, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Sodium Fluoride 2.43 mg/1 g
Other brand names
Dosage form
Paste, Dentifrice
Route
Oral
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 2017
Label revision date
November 11, 2025
Manufacturer
Xlear Inc.
Registration number
M021
NDC root
27017-142
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

You may be looking for information about a dental care product designed for both adults and children aged two years and older. This product is intended to help maintain oral hygiene by promoting thorough brushing of teeth, ideally after each meal or at least twice a day. It is important for children under six to be guided in proper brushing and rinsing techniques to prevent swallowing, and supervision is recommended until they can brush independently.

For children under two years of age, it is advised to consult a dentist or doctor before use. This product plays a crucial role in supporting good dental health habits from an early age, ensuring that both you and your children can maintain a healthy smile.

Uses

To maintain good oral health, it's important for you to brush your teeth thoroughly, ideally after each meal or at least twice a day. If you have children under 6 years old, make sure to teach them proper brushing and rinsing techniques to help prevent swallowing toothpaste. It's also a good idea to 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 with a dentist or doctor for guidance on dental care. Remember, taking these steps can help ensure a healthy smile for you and your family.

Dosage and Administration

To keep your teeth healthy, it's important to brush them thoroughly, especially after meals. If you're an adult or a child aged two years and older, you should aim to brush your teeth at least twice a day. If your dentist or doctor has given you specific instructions, be sure to follow those as well. Regular brushing helps prevent cavities and maintain good oral hygiene, so make it a part of your daily routine!

What to Avoid

You can feel reassured that there are no specific contraindications, controlled substance classifications, or concerns regarding abuse, misuse, or dependence associated with this medication. This means that, based on the available information, there are no known restrictions or risks that would prevent you from using it safely. Always consult with your healthcare provider if you have any questions or concerns about your treatment.

Side Effects

It’s important to keep this product out of reach of children under 6 years of age. If a child accidentally swallows more than what is typically used for brushing, seek medical help or contact a poison control center immediately.

Be aware that swallowing excessive amounts can lead to serious health concerns, so always use the product as directed. If you have any questions or concerns about its use, don’t hesitate to reach out to a healthcare professional.

Warnings and Precautions

It's important to keep this product out of reach of children under 6 years of age to prevent accidental ingestion. If you or someone else accidentally swallows more than the amount used for brushing, seek medical help immediately or contact a poison control center.

While there are no specific instructions for stopping use, if you have any concerns or experience unusual symptoms, it's always a good idea to consult your doctor for guidance. Your safety is a 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 your local poison control center. This is crucial to ensure your safety and receive the appropriate care.

Signs of an overdose may not be immediately obvious, but it’s always better to err on the side of caution. If you have any concerns about your health after swallowing too much, don’t hesitate to reach out for professional assistance. Your well-being is the top priority.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know 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 to ensure the best care for you and your baby.

Lactation Use

If you are breastfeeding, it's important to talk to your healthcare professional before using this product. There is a possibility that it can be passed into your breast milk, so caution is advised. The effects on your nursing infant have not been thoroughly studied, which means you should carefully weigh the potential risks against the benefits before making a decision.

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 teach them proper brushing and rinsing techniques to help prevent swallowing the product. Always supervise younger children until they can use it safely on their own.

If your child is under 2 years old, it's best to consult with a dentist or doctor before use. For children aged 2 and older, encourage them to brush their teeth thoroughly, ideally after each meal or at least twice a day, or follow the guidance of a healthcare professional.

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, dosage adjustments, or monitoring requirements mentioned for your condition in the provided information. This means that the standard recommendations for medication use may apply to you, but it's always best to consult with your healthcare provider for personalized advice. They can help ensure that any medications you take are safe and effective for your specific health needs.

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, and there are no special monitoring requirements or precautions outlined for patients with liver impairment.

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe for your liver health. They can provide guidance tailored to your specific situation.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. While there are no specific drug interactions or laboratory test interactions noted for this medication, your healthcare provider can help ensure that everything you are taking works well together and is safe for you. Always share your complete list of medications and any health conditions you have to receive the best care possible.

Storage and Handling

To ensure the best use of your product, store it at room temperature, which is typically between 68°F and 77°F (20°C to 25°C). It's important to keep the product out of reach of children under 6 years of age to prevent any accidental misuse or ingestion.

By following these simple storage and safety guidelines, you can help maintain the product's effectiveness and ensure a safe environment for everyone.

Additional Information

No further information is available.

FAQ

How should I use this product?

Adults and children two years and older should brush their teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor.

What should I do for children under 6 years of age?

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

What should I do if a child under 2 years needs to use this product?

Consult a dentist or doctor before using this product for children under 2 years of age.

Are there any warnings I should be aware of?

Keep this product out of reach of children under 6 years of age. If more than the recommended amount is accidentally swallowed, seek medical help or contact a poison control center immediately.

Is this product safe to use during pregnancy?

No specific information regarding safety during pregnancy is provided, so consult a healthcare professional for advice.

What about 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 and keep out of reach of children under 6 years of age.

Packaging Info

Below are the non-prescription pack sizes of Spry Dentifrice (toothpaste). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Spry Dentifrice.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

No description information is available for the specified drug.

Uses and Indications

This drug is indicated for the maintenance of oral hygiene through thorough brushing of teeth, preferably after each meal or at least twice daily, or as directed by a dentist or doctor. It is essential 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, consultation with a dentist or doctor is recommended prior to use.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Adults and children aged two years and older are advised to brush their teeth thoroughly, preferably after each meal or at least twice a day. This practice should be followed unless otherwise directed by a dentist or doctor. Proper brushing technique is essential for effective oral hygiene.

Contraindications

There are no contraindications associated with the use of this product. It is not classified as a controlled substance, and there are no known risks of abuse, misuse, or dependence.

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. In the event that more than the recommended amount for brushing is accidentally swallowed, immediate medical assistance should be sought. Healthcare professionals are advised to instruct patients to contact a poison control center or seek emergency medical help without delay.

Patients should be informed to discontinue use and consult their healthcare provider if they experience any adverse effects or if there are concerns regarding the product's use. Specific instructions for cessation are not provided; however, vigilance in monitoring for any unusual symptoms is recommended.

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 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 at higher risk of adverse reactions due to accidental ingestion.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Spry Dentifrice (toothpaste). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Spry Dentifrice.
Details

Pediatric Use

Pediatric patients under 6 years of age should be kept out of reach of the product. It is important to instruct children in this age group on proper brushing and rinsing techniques to minimize swallowing. 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 doctor is advised prior to use. For children aged 2 years and older, the recommended usage is to brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor.

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

Nursing mothers should consult a healthcare professional before using this product. There is a potential for excretion in breast milk; therefore, caution is advised when administering to nursing mothers. The effects on the nursing infant are not well studied; thus, the risks versus benefits should be considered.

Renal Impairment

There is no information available regarding renal impairment, including dosage adjustments, special monitoring, or safety considerations for patients with reduced kidney function. Healthcare professionals should exercise clinical judgment when prescribing to patients with renal impairment, as specific recommendations are not provided in the available data.

Hepatic Impairment

There is no information available regarding the use of this medication in patients with hepatic impairment. Consequently, there are no dosage adjustments, special monitoring requirements, or precautions specified for individuals with compromised liver function. Healthcare professionals should exercise caution and consider the overall clinical context when prescribing this medication to patients with liver problems, as the absence of specific guidance necessitates careful evaluation of potential risks and benefits.

Overdosage

In the event of an overdosage, immediate medical assistance is crucial. If an individual accidentally swallows more than the amount typically used for brushing, it is imperative to seek medical help or contact a poison control center without delay.

Healthcare professionals should be aware that prompt intervention can mitigate potential adverse effects associated with overdosage. Monitoring for symptoms related to the specific substance involved is essential, although specific symptoms were not detailed in the provided information.

Management procedures should include supportive care and symptomatic treatment as necessary, guided by the clinical presentation of the patient. It is advisable to follow established protocols for the management of overdosage in accordance with local guidelines and the specific characteristics of the substance involved.

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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

Postmarketing Experience

No postmarketing experience details are available in the insert.

Patient Counseling

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

Patients should be instructed on the importance of maintaining proper oral hygiene by brushing their teeth thoroughly. It is recommended that they brush their teeth preferably after each meal or at least twice a day, unless otherwise directed by a dentist or doctor. This practice is essential for optimal dental health and to maximize the effectiveness of the product.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers, which are essential for identification and inventory management. It is recommended to store the product at room temperature to maintain its efficacy and stability. Additionally, it is crucial to keep the product out of reach of children under 6 years of age to ensure safety and prevent accidental ingestion. Proper handling and storage practices should be followed to ensure the product remains effective and safe for use.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Spry Dentifrice, 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 Spry Dentifrice, 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.