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Closeup Travel

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This product has been discontinued

Active ingredient
Sodium Fluoride 0.21 g/100 g
Other brand names
Dosage form
Paste, Dentifrice
Route
Dental
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2022
Label revision date
August 10, 2022
Active ingredient
Sodium Fluoride 0.21 g/100 g
Other brand names
Dosage form
Paste, Dentifrice
Route
Dental
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2022
Label revision date
August 10, 2022
Manufacturer
GURUNANDA, LLC
Registration number
part355
NDC root
70708-182

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 product, you can take an important step towards maintaining your oral health and keeping your teeth strong. It's a supportive tool in your daily routine to help protect against the development of cavities.

Uses

You can use this product to help prevent dental cavities. By incorporating it into your oral care routine, you can support your dental health and reduce the risk of developing cavities, which are small holes in your teeth caused by decay. Regular use can contribute to a healthier smile and overall oral hygiene.

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 use only a pea-sized amount of toothpaste and supervise them while they brush and rinse to prevent swallowing any toothpaste.

For children younger than 2 years old, it's best to consult with a dentist or physician before using any toothpaste. They can provide guidance on the safest options for your little one’s dental care.

What to Avoid

It's important to ensure that any medication you use is kept safe and out of reach of children, especially those under 6 years of age. While there are no specific contraindications or concerns regarding abuse, misuse, or dependence associated with this medication, always prioritize safety by following this guideline. If you have any questions or concerns about using this medication, consult with your healthcare provider for personalized advice.

Side Effects

If you accidentally swallow more of this product than intended for brushing, it's important to seek medical help or contact a Poison Control Center immediately. This is a serious situation that requires prompt attention to ensure your safety. Always use the product as directed to avoid any potential risks.

Warnings and Precautions

If you accidentally swallow more of this product than intended for brushing your teeth, it’s important to seek medical help immediately or contact a Poison Control Center. Taking quick action can help ensure your safety.

Always use this product as directed and keep it out of reach of children to prevent accidental ingestion. If you have any concerns or experience unusual symptoms, stop using the product and call your doctor for advice. Your health and safety are the top priority.

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 can vary, 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 safety or use of this medication during pregnancy. This means that there are no established guidelines regarding dosage adjustments or special precautions for pregnant individuals.

Given this lack of information, it is crucial to consult with your healthcare provider before using this medication. They can help you weigh the potential risks and benefits based on your individual circumstances. Always prioritize open communication with your doctor about any medications you are considering during pregnancy.

Lactation Use

When it comes to breastfeeding, it's important to be aware that there are no specific guidelines or statements regarding nursing mothers or lactation (the process of producing milk). This means that if you are breastfeeding, you may not find detailed information about how certain medications or treatments could affect you or your baby.

If you have concerns about breastfeeding while taking any medication, it's always a good idea to consult with your healthcare provider. They can provide personalized advice based on your situation and help ensure the safety and well-being of both you and your infant.

Pediatric Use

It's important to keep this product out of reach of children under 6 years old. 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 physician.

If your child is under 6 years old, use only a pea-sized amount of the product and supervise their brushing and rinsing to help prevent swallowing. For children under 2 years of age, it's best to consult with a dentist or physician before use.

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 for personalized advice. 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

If you have kidney 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 usual recommendations for monitoring or safety considerations related to renal impairment (kidney issues) are not provided.

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe and appropriate for your kidney health. They can help you understand how your condition may affect your treatment plan.

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 function. 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 appropriately.

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

Drug Interactions

It's great to know that there are no reported interactions between this medication and other drugs or laboratory tests. This means you can feel more confident about using it alongside your current treatments or tests. However, it's still very important to discuss all medications and tests with your healthcare provider. They can help ensure that everything works well together and monitor your health effectively. Always keep an open line of communication with your doctor about any changes in your medications or health status.

Storage and Handling

To ensure the safety and effectiveness of your product, store it at room temperature. It's important to keep it out of reach of children to prevent any accidental ingestion or misuse. Once you open the product, be sure to discard it after use to maintain safety and hygiene. Following these simple guidelines will help you use the product safely and effectively.

Additional Information

You should use this product through dental administration, which means it's applied in the mouth. For adults and children aged 2 years and older, brush your teeth thoroughly, ideally after each meal or at least twice a day, unless your dentist or physician advises otherwise. If you're supervising a child under 6 years old, use only a pea-sized amount of the product and help them brush and rinse to prevent swallowing. For children under 2 years old, consult a dentist or physician before use.

FAQ

What is the purpose of this drug?

This drug aids in the prevention of dental cavities.

Who can use this drug?

Adults and children 2 years and older can use this drug. For children under 6 years, a pea-sized amount should be used under supervision.

What should I do if a child under 2 years needs to use this drug?

You should ask a dentist or physician before using this drug for children under 2 years of age.

What are the instructions for brushing with this drug?

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

Are there any contraindications for this drug?

No contraindications are listed for this drug.

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.

How should this drug be stored?

Store at room temperature and keep out of reach of children. Discard after opening.

Is there any information regarding use during pregnancy or lactation?

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

Are there any known drug interactions?

No drug interactions were found in the provided text.

Packaging Info

Below are the non-prescription pack sizes of Closeup Travel (sodium fluoride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Closeup Travel.
Details

Drug Information (PDF)

This file contains official product information for Closeup Travel, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

The product is identified by the code 51945-4 and is associated with the principal display panel, effective as of June 13, 2022. The labeling includes visual representations of both the front and back panels of the packaging, which are provided in JPEG format. The front panel image is referenced as "Close up travel kit- front panel.jpg," while the back panel image is referenced as "Close up travel kit- back panel.jpg."

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 a day, or as directed by a dentist or physician.

For children under 6 years of age, it is recommended to use only a pea-sized amount of the product. Caregivers should supervise the brushing and rinsing process to minimize the risk of swallowing.

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

Contraindications

Use is contraindicated in children under 6 years of age. This precaution is necessary to prevent potential harm, as the safety and efficacy of the product have not been established in this age group. Additionally, it is advised to keep the product out of reach of children to avoid accidental ingestion.

Warnings and Precautions

In the event of accidental ingestion of an amount exceeding that typically used for brushing, immediate medical assistance should be sought. Healthcare professionals are advised to contact a Poison Control Center without delay to ensure appropriate management and intervention.

Side Effects

Patients should be aware that if more than the recommended amount used for brushing is accidentally swallowed, it is imperative to seek medical assistance or contact a Poison Control Center immediately. This warning highlights the potential seriousness of accidental ingestion and underscores the importance of adhering to the recommended usage guidelines.

Drug Interactions

No drug interactions have been identified in the available data. Additionally, there are no reported interactions between drugs and laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on the current information.

Packaging & NDC

Below are the non-prescription pack sizes of Closeup Travel (sodium fluoride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Closeup Travel.
Details

Pediatric Use

Pediatric patients should be kept out of reach of children under 6 years of age. 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 as directed by a dentist or physician.

In children under 6 years of age, only a pea-sized amount should be used, and adult supervision is necessary during brushing and rinsing to minimize the risk of swallowing. For infants and children under 2 years of age, consultation with a dentist or physician is advised prior to use.

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, given the lack of targeted data for this population.

Pregnancy

There is no specific information available 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 the need to inform their healthcare provider if they become pregnant or plan to become pregnant while using this medication.

Lactation

There are no specific statements regarding the use of this medication in nursing mothers or its effects during lactation. Additionally, there is no available data on the excretion of this medication in breast milk or its potential effects on breastfed infants. Healthcare professionals should consider the absence of information when advising lactating mothers about the use of this medication.

Renal Impairment

Patients with renal impairment have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the text. Therefore, healthcare professionals should exercise caution and consider individual patient factors when prescribing to this population. Regular assessment of renal function may be warranted to ensure safe and effective use of the medication in patients with reduced kidney function.

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

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of the reach of children under 6 years of age. It is important to emphasize the potential risks associated with accidental ingestion by young children and to encourage patients to store the medication in a secure location.

Storage and Handling

The product is supplied in a configuration that ensures optimal handling and storage. It should be stored at room temperature to maintain its efficacy. It is essential to keep the product out of reach of children to prevent accidental ingestion. Once opened, the product must be discarded to ensure safety and effectiveness.

Additional Clinical Information

The product is administered via the dental route. For adults and children aged 2 years and older, it is recommended to brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician. For children under 6 years of age, only a pea-sized amount should be used, and adult supervision is necessary to minimize the risk of swallowing. For children under 2 years of age, consultation with a dentist or physician is advised prior to use.

No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Closeup Travel, 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 Closeup Travel, 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.