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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)
Marketed in the U.S.
Since 2024
Label revision date
January 15, 2026
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
Marketed in the U.S.
Since 2024
Label revision date
January 15, 2026
Manufacturer
Hismile Pty Ltd
Registration number
M021
NDC root
83013-313

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 drug is designed to help prevent dental cavities, which are small holes in your teeth caused by decay. By using this medication, 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. Keeping your teeth healthy is essential for maintaining a bright smile and overall well-being.

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 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 product to ensure your safety. You should not swallow the product, as it is not intended for ingestion. Additionally, avoid using it in the eye area to prevent irritation or injury.

By adhering to these instructions, you can help ensure a safe and effective experience with the product. If you have any questions or concerns, please consult with a healthcare professional.

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.

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 any 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

When it comes to using this medication during pregnancy, there is no specific information available about its safety, recommended dosage adjustments, or any special precautions you should take. This means that the potential risks and benefits are not clearly defined.

If you are pregnant or planning to become pregnant, it’s important to discuss any medications you are considering with your healthcare provider. They can help you understand the implications and make informed decisions that prioritize your health and the health of 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 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. For children in this age group, you should teach them good brushing and rinsing habits 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, consult a dentist or doctor before use.

For children aged 2 years and older, make sure they brush their teeth thoroughly, ideally after each meal or at least twice a day, unless directed otherwise by a dentist or doctor.

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. If you or a loved one is an older adult, it’s always wise to discuss any medications with a healthcare provider, especially since older individuals may have different health needs and responses to drugs.

Since there are no dosage adjustments or safety concerns specifically noted for elderly patients, your healthcare provider can help determine the best approach based on individual health conditions 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 medication or treatment, it's important to discuss these with your healthcare provider for personalized advice.

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 for the medication do not change based on liver impairment. However, it’s always a good idea to discuss your liver health with your healthcare provider, as they can offer personalized advice and monitor your condition effectively.

Make sure to keep them informed about any liver issues you may have, as they can help ensure that your treatment is safe and appropriate for you.

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 feel free to ask questions and share your complete list of medications and any lab tests you may be undergoing. This way, you can receive the best possible care tailored to your needs.

Storage and Handling

To ensure the best performance of your product, store it at room temperature in a cool, dry place. It's important to keep the container tightly closed to protect the contents from contamination and to prevent exposure to excessive heat, which can affect its effectiveness. Avoid freezing the product, as this can damage it.

Once opened, be mindful of the time frame for use. If you do not use the product within the specified time after opening, it is best to discard it to ensure safety and effectiveness. Following these guidelines will help you handle the product safely and maintain its quality.

Additional Information

The medication is administered through a dental route, which means it is used in dental care settings. If you have children, it's important to teach those under 6 years old good brushing and rinsing habits to help prevent swallowing the product. You should supervise younger children until they can use it safely on their own. Additionally, if your child is under 2 years old, 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.

Who can use this drug?

Adults and children 2 years of age and older can use this drug. For children under 2 years, consult a dentist or doctor.

How should I use this drug?

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

What precautions should I take for children under 6 years of age?

Instruct children 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?

If more than used for brushing is accidentally 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.

What should I avoid while using this drug?

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

How should I store this drug?

Store at room temperature, keep the container tightly closed, protect from excessive heat, and do not freeze.

Is there any information regarding use during pregnancy or nursing?

No specific information regarding use during pregnancy or nursing is provided.

What is the effective date for the information provided?

The effective time for the information provided is January 12, 2024.

Packaging Info

Below are the non-prescription pack sizes of Hismile (mango sorbet 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 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 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 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, immediate medical assistance should be sought. Contact a Poison Control Center or seek emergency medical help 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 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 (mango sorbet 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 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

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

There is no specific information 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

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

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, 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 have the product's labeling and any relevant patient information available when contacting medical professionals or poison control for guidance.

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 provided in the insert.

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 assistance 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 excessive heat, and must not be frozen. Healthcare professionals are advised to discard the product after opening if it is not used within the specified time frame.

Additional Clinical Information

The route of administration for the product is dental. Clinicians should instruct parents to teach children under 6 years of age proper brushing and rinsing habits to minimize 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.

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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.