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Hismile

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Active ingredient
Sodium Fluoride 2.4 mg/1 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
January 15, 2026
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Sodium Fluoride 2.4 mg/1 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
January 15, 2026
Manufacturer
Hismile Pty Ltd
Registration number
M021
NDC root
83013-311
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 drug, you can support your oral health and reduce the risk of developing cavities, contributing to a healthier smile.

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. 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. 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 specific contraindications or concerns about abuse, misuse, or dependence associated with this medication, 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. Make sure to keep it 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.

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 emergency medical help or contact a Poison Control Center immediately. Always prioritize safety and be aware of how to use the product correctly.

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

While the provided information does not specify any particular safety concerns or dosage modifications for pregnant individuals, it is always important to approach medication use during pregnancy with caution. Since there are no special precautions mentioned, you should consult your healthcare provider before taking any medication if you are pregnant or planning to become pregnant. They can provide personalized advice based on your health needs and circumstances.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to know that the information provided does not include specific guidelines or considerations for nursing mothers or lactation (the process of producing milk). This means that there are no detailed recommendations or warnings regarding the use of certain medications or substances while you are nursing.

Always consult with your healthcare provider for personalized advice and to ensure the safety of both you and your baby while breastfeeding. They can provide guidance based on your individual situation and any medications you may be considering.

Pediatric Use

It's important to keep this product out of reach of children under 6 years old. If your child is under 6, make sure to teach them good brushing and rinsing habits to help prevent swallowing. You should supervise younger children until they can use the product safely on their own.

For children under 2 years old, it's best to consult a dentist or doctor before use. For those aged 2 and older, encourage thorough brushing of teeth, ideally after each meal or at least twice a day, or follow the guidance of a dentist or doctor.

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 there are no specific guidelines, dosage adjustments, or special monitoring instructions provided for your condition in the available information. This means that the medication may not have been studied in depth for its effects on individuals with liver impairment.

Always consult your healthcare provider for personalized advice and to discuss any concerns you may have regarding your liver health and medication use. They can help ensure that your treatment is safe and effective based on your individual health needs.

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 full list of medications and any health conditions you have to receive the best care possible.

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. Once you open the container, please remember to discard it after use to maintain safety and effectiveness. Following these simple guidelines will help you use the product safely and effectively.

Additional Information

The medication is administered through a dental route, which means it is used in dental care settings. If you have children under 6 years old, it's important to teach them 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. For children under 2 years of age, it's advisable to consult a dentist or doctor before use.

FAQ

What is the primary use 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 for children under 6 years of age?

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

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

Consult a dentist or doctor before use.

Are there any warnings when using this product?

Yes, do not swallow the product 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 product?

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

Are there any contraindications or risks associated with this drug?

No specific contraindications, abuse risks, or dependence concerns are listed.

Is there any information regarding use during pregnancy or nursing?

The provided text does not include specific information about use during pregnancy or nursing mothers.

Packaging Info

Below are the non-prescription pack sizes of Hismile (peach iced tea flavor sodium fluoride anticavity toothpaste). 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 are advised to 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 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 without assistance.

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

Contraindications

Use of this product is contraindicated in the following situations:

  • Swallowing the product is prohibited due to potential adverse effects associated with ingestion.

  • Application in the eye area is contraindicated to prevent irritation or injury to the ocular tissues.

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 reach of children under 6 years of age.

Emergency Medical Assistance In the event that more than the recommended amount for brushing is accidentally swallowed, it is crucial to seek emergency medical assistance immediately or contact a Poison Control Center for guidance.

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 aware of the following 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 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 mitigate any potential adverse reactions.

Drug Interactions

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

Packaging & NDC

Below are the non-prescription pack sizes of Hismile (peach iced tea flavor sodium fluoride anticavity toothpaste). 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 that they brush their teeth thoroughly, preferably after each meal or at least twice daily, 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 adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

Pregnancy

Pregnant patients should be informed that there are no specific safety concerns regarding the use of this medication during pregnancy as detailed in the available prescribing information. Additionally, there are no dosage modifications recommended for pregnant individuals. Currently, there are no special precautions outlined for the use of this medication in pregnant patients. Healthcare professionals should continue to evaluate the benefits and risks of treatment in this population, considering the absence of specific data on fetal outcomes.

Lactation

There are no specific statements or considerations regarding lactation or nursing mothers in the provided text. Therefore, the effects on breastfed infants and the excretion of the drug in breast milk remain unspecified. Healthcare professionals should exercise caution and consider the potential risks and benefits when prescribing this medication to lactating mothers.

Renal Impairment

There is no information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution and consider the lack of specific guidance when prescribing to patients with reduced kidney function.

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 lack of data when prescribing this medication to patients with liver problems.

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 may be necessary, although specific symptoms related to overdosage are not detailed in the provided information.

Management procedures should include supportive care and symptomatic treatment as required. It is essential to follow established protocols for handling cases of overdosage to ensure patient safety and effective care.

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 are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to avoid swallowing the product and to use it only as directed for brushing. Instruct patients that if they accidentally swallow more than the recommended amount, they should seek medical help or contact a Poison Control Center immediately. Additionally, it is important to inform patients not to use 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. Additionally, 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.