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Ice Pop Flavor Sodium Fluoride Anticavity Toothpast

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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
83013-328

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Drug Overview

I'm sorry, but it seems that the information provided does not include any specific details about the drug's name, its uses, or its mechanism of action. Without these critical facts, I am unable to create a summary that describes what the drug is and what it is used for. If you have more information or a different set of details, please share, and I would be happy to help!

Uses

It seems that there are no specific uses or indications provided for this medication. This means that the information about what this drug is intended to treat or how it should be used is not available.

Additionally, there are no mentions of teratogenic effects (which are harmful effects on a developing fetus) or nonteratogenic effects (which do not affect fetal development). If you have any questions or need further information about this medication, it's best to consult with a healthcare professional.

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 use this product safely. You should avoid applying it to the eye area, as this can lead to irritation or other issues. Additionally, do not swallow the product, as it is not intended for ingestion and could cause harm.

There are no specific contraindications, controlled substance classifications, or concerns regarding abuse or dependence associated with this product. Always follow these guidelines to ensure your safety and well-being.

Side Effects

It's important to be aware of some key safety information regarding this product. First, you should never swallow it, and it should not be used around your eyes. Additionally, keep it out of reach of children, especially those 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.

By following these guidelines, you can help ensure safe use of the product.

Warnings and Precautions

When using this product, it's important to remember not to swallow it. Additionally, you should avoid applying it near your eyes.

Make sure to keep this product out of reach of children, especially those 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. Your safety and the safety of your loved ones are paramount, so please take these precautions seriously.

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 about the use of this medication during pregnancy. This means that safety concerns, dosage adjustments, or any special precautions have not been established.

Before taking this medication, you should discuss it with your healthcare provider to understand any potential risks and to ensure the best care for you and your baby. Always prioritize open communication with your doctor regarding any medications you may be considering during pregnancy.

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 using medications while breastfeeding.

Pediatric Use

It's important to keep this product 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. For children aged 2 years and older, you should encourage them to brush their teeth thoroughly, ideally after each meal or at least twice a day, following the guidance of a dentist or doctor.

For children under 6, make sure to teach them proper brushing and rinsing techniques to help prevent swallowing the product. Always supervise younger children while they brush until they are able to do 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.

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. As you age, your body may process medications differently, which can affect how well they work and the potential for side effects.

If you or a loved one is considering this medication, it’s wise to discuss it with a healthcare provider. They can help determine if any adjustments are needed based on individual health conditions and ensure that the treatment is safe and effective for older adults. Always prioritize open communication with your healthcare team about any concerns or questions you may have.

Renal Impairment

If you have kidney problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or safety considerations related to renal impairment (kidney issues). This means that there are no tailored recommendations for how your treatment may need to change based on your kidney function.

Always consult your healthcare provider for personalized advice and to ensure that your treatment plan is safe and effective for your specific situation. They can help monitor your kidney health and make any necessary adjustments to your medications.

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 full list of medications and any health concerns during your appointments to receive the best care possible.

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 remaining product, as it may no longer be safe to use. Following these guidelines will help you use the product safely and effectively.

Additional Information

No further information is available.

FAQ

What should I do if I accidentally swallow this product?

If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

How should I use this product?

Adults and children 2 years of age and older should brush 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 under 6 in good brushing and rinsing habits to minimize swallowing, and supervise them until they can use it without assistance.

Is this product safe for children under 2 years of age?

Consult a dentist or doctor before using this product for children under 2 years of age.

Are there any contraindications for this product?

No contraindications are listed for this product.

Can I use this product in the eye area?

No, do not use this product in the eye area.

What should I do to keep this product safe?

Keep out of reach of children under 6 years of age.

What storage conditions are recommended for this product?

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

Is there any information regarding the use of this product during pregnancy or lactation?

No specific information is provided regarding the use of this product during pregnancy or lactation.

Packaging Info

Below are the non-prescription pack sizes of Ice Pop Flavor Sodium Fluoride Anticavity Toothpast (sodium fluoride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Ice Pop Flavor Sodium Fluoride Anticavity Toothpast.
Details

Drug Information (PDF)

This file contains official product information for Ice Pop Flavor Sodium Fluoride Anticavity Toothpast, 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 use in patients as determined by the prescribing healthcare professional. Currently, there are no specific indications or usage details provided.

There are no known teratogenic or nonteratogenic effects associated with this drug. Healthcare professionals should consider the absence of these effects when evaluating treatment options for their patients.

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 eye area due to the potential for irritation or adverse effects. Additionally, the product should not be ingested, as swallowing may lead to harmful consequences.

Warnings and Precautions

When using this product, it is imperative that it is not swallowed. Ingestion can lead to adverse effects, and immediate medical attention should be sought if more than the recommended amount for brushing is accidentally ingested.

This product is contraindicated for use in the eye area. Application in this region may result in irritation or other complications.

To ensure safety, this product must be kept out of reach of children, particularly those under 6 years of age. Caregivers should be vigilant, as accidental ingestion can occur. In the event of accidental swallowing, it is crucial to seek medical assistance or contact a Poison Control Center without delay.

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, as ingestion may lead to adverse effects. Additionally, the product is contraindicated for use in the eye area, and care should be taken to avoid contact with this sensitive region.

To ensure safety, the product must be kept out of reach of children, particularly those under 6 years of age. In the event that more than the recommended amount is accidentally swallowed, it is crucial to seek medical assistance or contact a Poison Control Center immediately. These precautions are essential to prevent potential harm and ensure the safe use of the product.

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 warranted at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Ice Pop Flavor Sodium Fluoride Anticavity Toothpast (sodium fluoride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Ice Pop Flavor Sodium Fluoride Anticavity Toothpast.
Details

Pediatric Use

Pediatric patients under 6 years of age should be kept out of reach of children, as accidental ingestion of more than the recommended amount can necessitate immediate medical attention or contact with a Poison Control Center. For children aged 2 years and older, it is advised to brush teeth thoroughly, preferably after each meal or at least twice daily, or as directed by a dentist or doctor.

Children under 6 years should be instructed in proper brushing and rinsing techniques to minimize the risk of swallowing. Supervision is recommended until children are capable of brushing their teeth without assistance. For infants and children under 2 years of age, consultation with a dentist or doctor is recommended prior to use.

Geriatric Use

There is no specific information 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

There is no specific information available regarding the use of this medication during pregnancy, including safety concerns, dosage modifications, or special precautions that should be taken. Healthcare professionals are advised to consider the lack of data when prescribing this medication to pregnant patients. The potential risks and benefits should be carefully evaluated, and alternative treatments may be considered in consultation with the patient. Women of childbearing potential should be informed of the absence of established safety data during pregnancy.

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 from the use of this product during lactation.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children under 6 years of age. Instruct patients that if more than the recommended amount for brushing is accidentally swallowed, they should seek medical help or contact a Poison Control Center immediately.

It is important to inform patients that this product should not be used in the eye area. Additionally, healthcare providers should emphasize that patients must not swallow the product while using it. Clear communication of these points will help ensure safe and effective use of the product.

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 to prevent degradation. Once opened, the product should be discarded to ensure safety and efficacy.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Ice Pop Flavor Sodium Fluoride Anticavity Toothpast, 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 Ice Pop Flavor Sodium Fluoride Anticavity Toothpast, 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.