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Hismile

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This product has been discontinued

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
September 18, 2024
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
September 18, 2024
Manufacturer
Accupac LLC
Registration number
M021
NDC root
44038-0327

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Drug Overview

Candy Cane 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 candy cane 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 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. This applies to both adults and children aged 2 years and older. If you're helping a child under 6, make sure to teach them proper brushing and rinsing techniques to reduce the chance of swallowing toothpaste.

For younger children, specifically those under 2 years old, it's best to consult with a dentist or doctor before starting any brushing routine. Always supervise younger children while they brush their teeth until they are capable of doing it on their own. This way, you can ensure they develop good habits for a lifetime of dental health.

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 the safety of those around you.

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 be aware that there is no specific information available regarding the use of this medication during pregnancy. This means that safety concerns, dosage adjustments, or any special precautions have not been established.

Before taking any medication, including this one, you should consult with your healthcare provider to discuss potential risks and benefits. Your doctor can help you 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 considerations mentioned regarding nursing mothers or lactation in the information provided. This means that, based on the available data, there are no known risks associated with breastfeeding while using this medication. However, it's always a good idea to consult with your healthcare provider if you have any concerns or questions about your specific situation.

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 advice of their 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 a good idea to discuss any medications with a healthcare provider. They can help ensure that the treatment is safe and appropriate, considering any unique health needs or conditions that may be present.

Remember, even in the absence of specific guidelines, your healthcare team can provide valuable insights and monitor for any potential side effects or interactions with other medications you may be taking. Always prioritize open communication with your doctor about your health and any concerns you may have.

Renal Impairment

It appears that there is no specific information regarding renal impairment (kidney problems) in the provided text. This means there are no dosage adjustments, special monitoring, or safety considerations outlined 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, who can offer personalized guidance based on your individual situation.

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, but you should always consult your healthcare provider for personalized advice. They can help determine the best approach for your treatment and monitor your liver function as needed.

Make sure to keep your doctor informed about your liver health, as they may need to conduct regular tests to ensure your safety while using any medication. Your well-being is a priority, so don't hesitate to ask questions or express any concerns you may have.

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 this medication is generally considered safe to use alongside other treatments and tests. However, every individual is different, and your healthcare provider can help ensure that your overall treatment plan is safe and effective for you. Always feel free to ask questions or express any concerns you may have regarding your medications or tests.

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

You should be aware that this medication is administered through dental means. If you have children under 6 years old, it's important to teach them proper brushing and rinsing techniques to help prevent swallowing the medication. Always supervise younger children until they can use it safely on their own. For children under 2 years old, consult a dentist or doctor before use to ensure it's appropriate for them.

FAQ

What is Candy Cane Flavor Sodium Fluoride Anticavity Toothpaste used for?

It aids in the prevention of dental cavities.

How should adults and children 2 years of age and older use this toothpaste?

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

What precautions should I take when using this toothpaste with 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 assistance.

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

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

Are there any contraindications for using this toothpaste?

No contraindications are listed.

What should I avoid while using this toothpaste?

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

How should I store Candy Cane Flavor Sodium Fluoride Anticavity Toothpaste?

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

Is there any specific information regarding the use of this toothpaste during pregnancy or while nursing?

No specific warnings or considerations are mentioned for pregnancy or nursing mothers.

Is there any information about drug interactions with this toothpaste?

No specific drug interactions are mentioned.

Packaging Info

Below are the non-prescription pack sizes of Hismile (candy cane 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

Candy Cane Flavor Sodium Fluoride Anticavity Toothpaste is formulated to provide effective dental care. This toothpaste contains sodium fluoride, which is known for its anticavity properties. The product is designed to help prevent dental caries while delivering a pleasant candy cane flavor. The effective date for this formulation is July 23, 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 a day, 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. 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 for appropriate guidance on dental care.

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 Help Instructions In the event that more than the recommended amount for brushing is swallowed, immediate medical assistance should be sought. Contact a Poison Control Center or seek emergency medical help without delay.

Stop Taking and Call Your Doctor Instructions No specific instructions for discontinuation or consultation with a healthcare provider are provided in the insert.

Side Effects

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

Additionally, the product must 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 for this medication. Additionally, there are no reported interactions with laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug or laboratory test interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Hismile (candy cane 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 healthcare professional.

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 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 and should be informed of the absence of established safety data in pregnancy.

Lactation

There are no specific warnings or considerations regarding nursing mothers or lactation mentioned in the provided text. Therefore, healthcare professionals may consider the use of this medication in lactating mothers without specific contraindications. However, as with any medication, the benefits and risks should be assessed on a case-by-case basis.

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 available information 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 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 excessive ingestion is essential, although specific symptoms were not detailed in the provided information.

Management of overdosage should focus on supportive care and symptomatic treatment as necessary. It is advisable to follow established protocols for handling cases of overdosage, ensuring that the patient receives appropriate evaluation and 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 use of the compound in these contexts.

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. Patients should be informed 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 instruct 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, ensuring that it is protected from light exposure. 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 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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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.