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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)
Marketed in the U.S.
Since 2024
Label revision date
January 15, 2026
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
Marketed in the U.S.
Since 2024
Label revision date
January 15, 2026
Manufacturer
HISMILE PTY LTD
Registration number
M021
NDC root
83013-325

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 interested to know that this medication is designed to help prevent dental cavities. It works by providing support to your dental health, making it easier for you to maintain a healthy smile. While specific details about its mechanism of action are not provided, its primary purpose is to aid in cavity prevention, which is an important aspect of oral care.

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 these issues. Keeping your teeth healthy is important for your overall well-being, so consider this option as part of your strategy to maintain a bright and 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. It's a good idea to supervise them 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 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

When using this product, it's important to avoid swallowing it and to keep it away from your eyes. Additionally, make sure to 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.

Please be aware of these precautions to ensure safe use.

Warnings and Precautions

It's important to use this product safely. Do not swallow it or apply it near your eyes. If you accidentally swallow more than what is needed for brushing, seek medical help immediately or contact a Poison Control Center.

While there are no specific lab tests required for this product, always prioritize your safety by following these guidelines. If you have any concerns or experience unusual symptoms, don’t hesitate to reach out to your healthcare provider.

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 the information provided does not specify any safety concerns related to the use of this medication during pregnancy. There are also no recommended dosage modifications for pregnant individuals, and no special precautions are mentioned regarding its use in this context.

As always, it's best to consult with your healthcare provider about any medications you are considering or currently taking to ensure they are safe for you and your baby.

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 noted about lactation or the possibility of the product being passed into breast milk. This means that, based on the available information, you can use this product without special concerns related to breastfeeding.

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 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, unless directed otherwise by 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

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

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 (liver issues).

Always consult your healthcare provider for personalized advice and to discuss any concerns regarding your liver health and how it may relate to your treatment. They can help ensure that you receive the safest and most effective care.

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 recent lab tests to avoid any potential issues. Your health and safety should always come first.

Storage and Handling

To ensure the best quality and safety of your product, store it at room temperature in a cool, dry place. It's important to keep the container tightly closed to prevent contamination and maintain its effectiveness. Additionally, protect the product from light, as exposure can affect its quality. Once you open the container, be sure to discard any unused product to avoid potential safety risks. 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 dental settings. If you are a parent or guardian, it's important to teach children under 6 years old proper brushing and rinsing habits to help prevent swallowing the medication. Additionally, you should supervise young children while they are using the medication until they are able to do so independently.

FAQ

What is the main purpose of this drug?

This drug aids in the prevention of dental cavities.

How should adults and children 2 years and older use this product?

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

What should I do if a child under 6 years of age is using this product?

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

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 this drug?

No contraindications are listed for this drug.

Can this product be used in the eye area?

No, you should not use this product in the eye area.

What precautions should I take when using this product?

Do not swallow the product and keep it out of reach of children under 6 years of age.

Is this product safe to use during pregnancy or while nursing?

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

How should I store this product?

Store at room temperature, keep the container tightly closed, and protect it from light.

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

No description information is available for the drug.

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

The product is contraindicated for ingestion and should not be applied in the eye area. Healthcare professionals must advise patients to avoid swallowing the product. In the event that more than the recommended amount for brushing is accidentally ingested, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay.

It is essential to educate patients on the importance of adhering to these guidelines to prevent potential adverse effects. No specific laboratory tests are required for monitoring the safe use of this product. However, vigilance in patient education regarding the proper application and potential risks is crucial for ensuring safety.

Side Effects

Patients should be aware of the following warnings and precautions 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 reach of children under 6 years of age. In the event that more than the recommended amount for brushing is accidentally swallowed, it is crucial to seek medical assistance or contact a Poison Control Center immediately.

These precautions are essential to ensure the safe use of the product and to minimize the risk of adverse reactions.

Drug Interactions

There are currently no documented drug interactions associated with the use of 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 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 these children in proper brushing and rinsing habits 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 children aged 2 years and older, it is recommended to brush teeth thoroughly, preferably after each meal or at least twice a day, 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

Pregnant patients may use this medication as no specific safety concerns regarding pregnancy have been detailed in the prescribing information. There are no dosage modifications recommended for pregnant individuals, nor are there any special precautions regarding its use during pregnancy. Healthcare professionals should continue to evaluate the benefits and risks when prescribing this medication to women of childbearing potential.

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 regarding lactation or the potential for excretion in breast milk.

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 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 and providing appropriate management based on clinical presentation is essential. It is recommended that healthcare providers familiarize themselves with local Poison Control resources to ensure rapid access to expert guidance in such situations.

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 these contexts.

Postmarketing Experience

No postmarketing experience details are provided in the insert.

Patient Counseling

Healthcare providers should advise patients to avoid swallowing the product, as it is intended for external use only. Instruct patients to seek immediate medical assistance or contact a Poison Control Center if they accidentally swallow more than the amount used for brushing. Additionally, it is important to inform patients that the product should not be applied 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. Additionally, supervision is recommended for children until they are capable of using the product without assistance.

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.