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Hismile

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Active ingredient
Sodium Fluoride 0.243 g/100 g
Other brand names
Dosage form
Gel
Route
Dental
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2024
Label revision date
December 4, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Sodium Fluoride 0.243 g/100 g
Other brand names
Dosage form
Gel
Route
Dental
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 2024
Label revision date
December 4, 2024
Manufacturer
Accupac LLC
Registration number
M021
NDC root
44038-0324
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

Pink Lemonade Flavor Sodium Fluoride Anticavity Toothpaste is designed to help prevent dental cavities. This toothpaste contains sodium fluoride, which is a common ingredient known for its ability to strengthen tooth enamel and protect against decay.

Using this toothpaste regularly can contribute to maintaining good oral health by reducing the risk of cavities, making it a helpful addition to your daily dental care routine. Plus, its pink lemonade flavor adds a pleasant taste to your brushing experience.

Uses

You can use this product to help prevent dental cavities, which are small holes in your teeth caused by decay. 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. If you're helping a child under 6, make sure to teach them good brushing and rinsing habits to prevent swallowing toothpaste. You should supervise younger children 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 properly. Following these steps will help ensure that you and your family maintain good oral hygiene.

What to Avoid

It's important to follow specific guidelines when using this medication to ensure your safety. You should not swallow the medication or use it in the eye area, as these actions can lead to unwanted effects.

While there are no listed contraindications, controlled substance classifications, or concerns about abuse, misuse, or dependence, adhering to these instructions is crucial for your well-being. Always consult with your healthcare provider if you have any questions or concerns about your treatment.

Side Effects

It's important to be aware of some key safety information regarding this product. You should never swallow it or use it near your eyes. Additionally, keep it 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.

Warnings and Precautions

It's important to use this product safely. Do not swallow it or apply it near your eyes. Keep it out of reach of children under 6 years old to prevent accidental ingestion.

If you accidentally swallow more than what is needed for brushing, seek medical help immediately or contact a Poison Control Center. Always prioritize your safety and well-being when using this product.

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 know that there are no specific warnings, precautions, or dosage changes related to the use of this product during pregnancy. This means that, based on the available information, it is considered safe to use as directed. However, always consult with your healthcare provider before starting any new medication or treatment during pregnancy to ensure it is appropriate for your individual situation. Your health and the health of your baby are the top priority.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations against using this product while nursing. Currently, there is no information available about whether this product is excreted in breast milk or if it poses any risk to your infant.

As always, it's a good idea to consult with your healthcare provider if you have any concerns or questions about using medications while breastfeeding. Your health and the health of your baby are important, and your provider can help you make informed decisions.

Pediatric Use

It's important to keep this product out of the 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

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 best approach for you or your loved one, considering any existing health conditions or medications that may interact.

Remember, your safety and well-being are the top priority, so don’t hesitate to ask questions and discuss any concerns with your doctor.

Renal Impairment

It appears that there is no specific information regarding renal impairment (kidney problems) in the provided text. Therefore, there are no dosage adjustments, special monitoring, or safety considerations to discuss for patients with kidney issues. If you have concerns about how your kidney health may affect your treatment, it's important to consult your healthcare provider for personalized advice and guidance.

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 differently due to your liver health.

Always consult your healthcare provider for personalized advice and to discuss any concerns you may have regarding your liver function and how it relates to your treatment. They can help ensure that your medication is safe and effective for you.

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 discuss any new medications or tests with your healthcare provider to avoid potential issues and to get the best care tailored to your needs.

Storage and Handling

To ensure the best quality and safety of your product, store it at room temperature, away from direct light. It's important to keep the container tightly closed when not in use to prevent contamination and maintain its effectiveness. Once you open the container, be sure to discard any remaining product, as it should not be reused. Following these guidelines will help you use the product safely and effectively.

Additional Information

The medication is administered through a dental route, meaning it is used in a dental setting. If you have children, it's important to teach those under 6 years old about good brushing and rinsing habits to help prevent swallowing the medication. You should supervise younger children until they can use it safely on their own. Additionally, if your child is under 2 years old, consult with a dentist or doctor before use.

FAQ

What is Pink Lemonade Flavor Sodium Fluoride Anticavity Toothpaste used for?

It aids in the prevention of dental cavities.

How should I use this toothpaste?

Adults and children 2 years of age 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 if my child is under 2 years old?

Consult a dentist or doctor before use.

Are there any warnings I should be aware of?

Do not swallow the toothpaste and do not use it in the eye area.

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

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

How should I store this toothpaste?

Store at room temperature, protect from light, and keep the container tightly closed. Discard after opening.

Is there any specific information regarding use during pregnancy or nursing?

There are no specific warnings or recommendations regarding use during pregnancy or by nursing mothers.

What precautions should I take with children?

Keep out of the reach of children under 6 years of age, instruct them in good brushing and rinsing habits, and supervise them until they can use it without assistance.

Packaging Info

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

Packaging configurations for Hismile.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Pink Lemonade Flavor Sodium Fluoride Anticavity Toothpaste is formulated to provide effective cavity protection. The active ingredient, sodium fluoride, contributes to the prevention of dental caries. This toothpaste is characterized by its distinct pink lemonade flavor, enhancing the user experience while maintaining oral hygiene. The product is designed for daily use and is suitable for individuals seeking to improve their dental health. The effective time for this formulation is set for July 15, 2024.

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 doctor. It is important to instruct children under 6 years of age in proper brushing and rinsing techniques to minimize the risk of swallowing the product. Caregivers should supervise children as necessary until they are capable of brushing their teeth without assistance.

For children under 2 years of age, it is recommended to consult a dentist or doctor prior to use.

Contraindications

Use of this product is contraindicated in the following situations:

Swallowing the product is prohibited, as it may lead to adverse effects. Additionally, application in the eye area is contraindicated due to the potential for irritation or injury.

Warnings and Precautions

It is imperative to adhere to the following warnings and precautions to ensure the safe use of this product.

Warnings This product is not intended for ingestion; therefore, it must not be swallowed. Additionally, it should not be applied in the eye area to prevent potential irritation or injury.

General Precautions To ensure safety, this product should be kept out of the reach of children under 6 years of age.

Emergency Medical Assistance In the event that more than the recommended amount for brushing is swallowed, it is crucial to seek emergency medical assistance immediately or contact a Poison Control Center without delay.

Discontinuation of Use Patients are advised to stop using the product and consult their healthcare provider if any adverse reactions occur, although specific instructions for discontinuation were not provided in the available information.

Side Effects

Patients should be advised of specific warnings associated with the use of this product. It is imperative that the product is not swallowed and is not used in the eye area.

Additionally, the product should be kept out of the reach of children under 6 years of age. In the event that more than the recommended amount for brushing is swallowed, patients should seek medical assistance or contact a Poison Control Center immediately.

Drug Interactions

No specific drug interactions have been identified in the available data. Additionally, there are no reported interactions with laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on the current information.

Packaging & NDC

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

Packaging configurations for Hismile.
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 the risk of 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 those aged 2 years and older, it is recommended to brush teeth thoroughly, preferably after each meal or at least twice daily, or to use the product as directed by a dentist or doctor.

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

The available data does not indicate any specific warnings, precautions, or dosage modifications for the use of this product during pregnancy. Healthcare professionals should consider the absence of documented risks when prescribing this product to pregnant patients. However, as with any medication, the potential benefits must be weighed against any unknown risks to fetal outcomes. It is advisable for women of childbearing potential to discuss their pregnancy status and any concerns with their healthcare provider prior to initiating treatment.

Lactation

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

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 caution and consider the lack of specific guidance when treating patients with renal impairment.

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 overdosage, immediate medical assistance is crucial. If an individual swallows an amount exceeding that 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 a thorough assessment of the patient's condition and the implementation of appropriate treatment protocols as guided by clinical judgment and established medical guidelines.

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

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to avoid swallowing the product, as ingestion beyond the amount used for brushing may necessitate immediate medical assistance or contact with a Poison Control Center. It is crucial to emphasize that the product is not intended for ingestion and should be used strictly as directed. Additionally, patients should be informed not to apply the product in the eye area to prevent potential irritation or injury.

Storage and Handling

The product is supplied in a container that must be kept tightly closed to maintain its integrity. It should be stored at room temperature, away from direct light exposure to protect its quality. Once opened, the product should be discarded to ensure safety and efficacy.

Additional Clinical Information

The route of administration for the product is dental. Clinicians should instruct parents or guardians to teach children under 6 years of age proper brushing and rinsing habits to minimize the risk of swallowing. Supervision is recommended for children until they are capable of using the product without assistance. For children under 2 years of age, it is advised to consult a dentist or doctor prior to use.

Drug Information (PDF)

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