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Shopkins Bubble Gum Mouth Wash

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This product has been discontinued

Active ingredient
Sodium Fluoride 0.05 mg/100 g
Other brand names
Dosage form
Liquid
Route
Dental
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2017
Label revision date
January 11, 2017
Active ingredient
Sodium Fluoride 0.05 mg/100 g
Other brand names
Dosage form
Liquid
Route
Dental
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2017
Label revision date
January 11, 2017
Manufacturer
Foshan Nanhai Jiachun Biology Engineering Co. , Ltd
Registration number
part355
NDC root
71106-001

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Drug Overview

This medication is designed to help protect your teeth and roots against cavities. By using it regularly, you can support your dental health and reduce the risk of tooth decay. It's an important part of maintaining a healthy smile and ensuring your teeth stay strong.

Uses

You can use this product to help protect your teeth and roots from cavities. By strengthening your dental health, it plays a crucial role in preventing tooth decay, ensuring that your smile stays healthy and bright. Regular use can contribute to better oral hygiene and overall dental well-being.

Dosage and Administration

After you brush your teeth, you can use this mouthwash daily to help keep your mouth healthy. First, make sure to rinse out any leftover toothpaste from your mouth. Then, measure out 15 ml, which is about 3 teaspoonfuls, and rinse or gargle with it for 30 seconds. After that, simply spit it out.

It's important to remember not to swallow the mouthwash. This routine is suitable for both adults and children aged 6 years and older, helping to maintain good oral hygiene.

What to Avoid

There are no specific contraindications, controlled substance classifications, or concerns regarding abuse, misuse, or dependence associated with this medication. This means that, based on the available information, there are no particular situations or conditions under which you should avoid using it. Always consult with your healthcare provider for personalized advice and to ensure that this medication is appropriate for your individual health needs.

Side Effects

It's important to keep this medication out of reach of children. If you or someone else accidentally swallows it, seek medical help or contact a poison control center right away.

Currently, there are no specific side effects or adverse reactions reported for this medication. However, always stay informed and consult your healthcare provider if you have any concerns or experience unusual symptoms.

Warnings and Precautions

It's important to keep this medication out of reach of children to prevent accidental ingestion. If a child or anyone else accidentally swallows it, seek medical help or contact a poison control center right away.

Always be cautious and monitor for any unusual symptoms. If you experience any concerning side effects, stop using the medication and call your doctor for guidance. Your safety is a priority, so don’t hesitate to reach out for help if needed.

Overdose

If you accidentally swallow too much of this medication, it’s important to act quickly. Seek medical help or contact a poison control center right away. Signs of an overdose can include unusual symptoms, so being aware of how you feel is crucial.

Remember, if you notice any concerning changes in your health after taking the medication, don’t hesitate to reach out for help. Your safety is the top priority, and getting prompt assistance can make a significant difference.

Pregnancy Use

There is currently no specific information available regarding the use of Shopkins Bubble Gum Mouth Wash during pregnancy. This means that safety concerns, dosage adjustments, or any special precautions for pregnant individuals have not been addressed in the product's guidelines.

If you are pregnant or planning to become pregnant, it is always best to consult with your healthcare provider before using any new products, including mouthwash, to ensure they are safe for you and your baby.

Lactation Use

When breastfeeding, it's important to be aware of how certain medications may affect you and your baby. While the specific information about nursing mothers and lactation (the process of producing milk) isn't detailed here, it's always best to consult with your healthcare provider about any medications you are considering. They can help you understand any potential risks and ensure that both you and your baby remain healthy during your breastfeeding journey.

If you have concerns about how a specific drug might impact your milk production or your infant, don't hesitate to ask your doctor for guidance tailored to your situation. Your health and your baby's well-being are the top priorities.

Pediatric Use

It's important to keep this product out of reach of children to prevent accidental ingestion. If a child accidentally swallows it, seek professional help or contact a poison control center right away.

For children aged 6 years and older, you can use this mouthwash daily after brushing their teeth. Make sure they rinse their mouth to remove any toothpaste before using the mouthwash. They should gargle or rinse with 15 ml (which is about 3 teaspoonfuls) for 30 seconds and then spit it out. Remind them not to swallow the mouthwash.

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 for patients with 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 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 differently due to your liver health.

Always consult your healthcare provider for personalized advice and to discuss any concerns you may have regarding your liver function and how it relates to your treatment. They can help ensure that your medication is safe and effective for you.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking, even if there are no specific drug interactions or laboratory test interactions noted for your treatment. This ensures that your healthcare team can monitor your health effectively and make informed decisions about your care.

Always feel free to ask questions and share all the medications and supplements you are using. This helps to avoid any potential issues and ensures that you receive the best possible treatment tailored to your needs.

Storage and Handling

It's important to keep this product out of reach of children to ensure their safety. When using the mouthwash, please remember not to swallow it, as it is not meant for ingestion. After you open the bottle, be sure to discard any unused mouthwash to maintain safety and effectiveness. Following these guidelines will help you use the product safely and responsibly.

Additional Information

You should use this mouthwash daily after brushing your teeth. First, rinse the toothpaste from your mouth, then take 15 ml (which is about 3 teaspoonfuls) of the mouthwash. Gargle or rinse for 30 seconds before spitting it out—make sure not to swallow it.

It's important to keep this product out of reach of children. If a child accidentally swallows it, or if you accidentally ingest it, seek professional help or contact a poison control center right away.

FAQ

What is the purpose of this mouth wash?

This mouth wash helps protect teeth and roots against cavities.

How should I use the mouth wash?

Use the mouth wash daily after brushing your teeth. Rinse toothpaste from your mouth, then gargle or rinse for 30 seconds with 15ml (3 teaspoonful) and spit it out. Do not swallow the mouth wash.

What should I do if I accidentally swallow the mouth wash?

If you accidentally swallow the mouth wash, seek medical help or contact a poison control center immediately.

Who can use this mouth wash?

This mouth wash is intended for adults and children 6 years and older.

Are there any contraindications for this mouth wash?

No specific contraindications are listed for this mouth wash.

What precautions should I take with this mouth wash?

Keep the mouth wash out of reach of children and do not swallow it.

Is there any information about using this mouth wash during pregnancy or while nursing?

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

Are there any known side effects or adverse reactions?

No specific side effects or adverse reactions are mentioned for this mouth wash.

What should I do with the mouth wash after opening?

Discard the mouth wash after opening.

Packaging Info

Below are the non-prescription pack sizes of Shopkins Bubble Gum Mouth Wash (sodium fluoride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Shopkins Bubble Gum Mouth Wash.
Details

Drug Information (PDF)

This file contains official product information for Shopkins Bubble Gum Mouth Wash, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

No specific description details are available for SPL code 34089-3.

Uses and Indications

This drug is indicated for the protection of teeth and roots against cavities. It is designed to help maintain oral health by reducing the risk of dental caries.

Dosage and Administration

Adults and children aged 6 years and older are advised to use the mouthwash daily following their regular tooth brushing routine. Prior to the use of the mouthwash, it is essential to rinse the mouth thoroughly to remove any residual toothpaste.

For administration, the recommended dosage is 15 ml (equivalent to 3 teaspoonfuls). The mouthwash should be rinsed or gargled in the mouth for a duration of 30 seconds. After gargling, the solution must be expectorated; it is imperative that the mouthwash is not swallowed.

Contraindications

There are no contraindications associated with the use of this product. It is deemed safe for use in the absence of specific conditions or situations that would warrant avoidance.

Warnings and Precautions

It is imperative to keep this medication out of reach of children to prevent accidental ingestion. In the event of accidental swallowing, immediate medical assistance should be sought, or the individual should contact a poison control center without delay.

Healthcare professionals are advised to educate patients and caregivers about the importance of proper storage and the actions to take in case of accidental ingestion. This precaution is essential to ensure the safety and well-being of all individuals, particularly vulnerable populations such as children.

Side Effects

Patients should be advised to keep the product out of reach of children. In the event of accidental ingestion, it is crucial to seek medical assistance or contact a poison control center immediately.

No specific side effects or adverse reactions have been reported in clinical trials or postmarketing experiences.

Drug Interactions

There are no specific drug interactions or laboratory test interactions identified in the available data. Therefore, no dosage adjustments or monitoring recommendations are necessary at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Shopkins Bubble Gum Mouth Wash (sodium fluoride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Shopkins Bubble Gum Mouth Wash.
Details

Pediatric Use

Pediatric patients should be kept out of reach of children. In the event of accidental ingestion, it is crucial to seek professional assistance or contact a poison control center immediately.

For children aged 6 years and older, the recommended usage involves daily application after normal brushing. Patients should rinse their mouths to remove toothpaste prior to use. The mouthwash should be used by rinsing or gargling for 30 seconds with 15 ml (3 teaspoonfuls) and then spitting it out. It is important to instruct pediatric patients not to swallow the mouthwash.

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 Shopkins Bubble Gum Mouth Wash during pregnancy, including safety concerns, dosage modifications, or special precautions. Healthcare professionals should consider the absence of data when advising pregnant patients. It is recommended that women of childbearing potential discuss the use of this product with their healthcare provider to weigh potential risks and benefits.

Lactation

There is no specific information available regarding the excretion of this medication in breast milk or its effects on breastfed infants. Healthcare professionals should consider the potential risks and benefits when prescribing this medication to lactating mothers. Further studies may be necessary to fully understand the implications of this medication during lactation.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring.

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, it is imperative that immediate medical assistance is sought. Healthcare professionals should advise patients or caregivers to contact a poison control center without delay if an accidental ingestion occurs.

Symptoms of overdosage may vary depending on the substance involved; however, it is crucial to monitor for any adverse reactions. Prompt recognition of symptoms can facilitate timely intervention and management.

Management of overdosage typically involves supportive care and symptomatic treatment. Healthcare providers should ensure that the patient is stabilized and closely monitored. Depending on the severity of the situation, further interventions may be necessary, including the administration of activated charcoal or other specific antidotes, if applicable.

In all cases of suspected overdosage, the involvement of poison control and emergency medical services is essential to ensure appropriate care and management.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

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 reach of children to prevent accidental ingestion. It is important to emphasize the potential risks associated with accidental digestion. In the event of such an occurrence, patients should be instructed to seek professional assistance or contact a poison control center immediately for guidance.

Storage and Handling

The product is supplied in a configuration that ensures safety and efficacy. It is essential to keep the product out of reach of children to prevent accidental ingestion. Users are advised not to swallow the mouthwash, as it is intended for rinsing purposes only.

Once opened, the product should be discarded to maintain safety and effectiveness. Proper handling and adherence to these guidelines are crucial for optimal use.

Additional Clinical Information

The product is administered via the dental route and is intended for daily use following normal brushing. Patients should rinse their mouths to remove toothpaste prior to use, then gargle or rinse with 15 ml (3 teaspoonfuls) for 30 seconds before spitting it out. It is crucial that patients do not swallow the mouthwash.

Clinicians should advise patients to keep the product out of reach of children. In the event of accidental ingestion, patients are instructed to seek professional assistance or contact a poison control center immediately.

Drug Information (PDF)

This file contains official product information for Shopkins Bubble Gum Mouth Wash, 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 Shopkins Bubble Gum Mouth Wash, 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.