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Rain Breeze Toothpaste

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This product has been discontinued

Active ingredient
Sodium Fluoride 0.22 g/100 g
Other brand names
Dosage form
Paste
Route
Dental
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2010
Label revision date
August 26, 2010
Active ingredient
Sodium Fluoride 0.22 g/100 g
Other brand names
Dosage form
Paste
Route
Dental
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2010
Label revision date
August 26, 2010
Manufacturer
Yangzhou Hengyuan Daily Chemical Plastic Co. , Ltd.
Registration number
part355
NDC root
51289-100

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

You may be interested to know that this medication helps protect against cavities, which are small holes in your teeth caused by decay. By using this product, you can support your dental health and help maintain a bright, healthy smile. While the specific details about how it works are not provided, its primary purpose is to safeguard your teeth from damage.

Uses

You can use this product to help protect against cavities, which are small holes in your teeth caused by decay. It's important to maintain good oral hygiene, and this product can be a helpful part of your routine to keep your teeth healthy.

Additionally, there are no concerns regarding teratogenic effects (which means it does not cause birth defects) or nonteratogenic effects associated with this product. This makes it a safe option for most users.

Dosage and Administration

To keep your teeth healthy, it's important to brush thoroughly, ideally after each meal or at least twice a day. This applies to both adults and children aged 6 years and older. If you have any specific instructions from your dentist or physician, be sure to follow those as well.

For children aged 2 to 6, use only a pea-sized amount of toothpaste. It's essential to supervise their brushing and rinsing to help prevent them from swallowing the toothpaste. If your child is under 2 years old, it's best to consult with a dentist or physician for guidance on how to care for their teeth.

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 conditions or situations in 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 product out of reach of children 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 right away.

Always be aware of how you use this product to ensure safety for yourself and others.

Warnings and Precautions

It's important to keep this product out of reach of children under 6 years of age to prevent accidental ingestion. If a child accidentally swallows more than what is typically used for brushing, seek medical help or contact a poison control center right away.

Always use this product as directed. If you experience any unusual symptoms or reactions, stop using it and call your doctor for further advice. Your safety is a priority, so don’t hesitate to reach out for help if needed.

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 right away 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

There is currently no specific information available about the use of RAIN BREEZE TOOTHPASTE during pregnancy. This means that the drug insert does not provide details on safety concerns, dosage adjustments, or any special precautions you should take if you are pregnant or planning to become pregnant.

If you have any concerns about using this toothpaste while pregnant, it’s best to consult with your healthcare provider for personalized advice. They can help you make informed decisions based on your individual health needs.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to know that there is no specific information available regarding the safety or effects of this medication on nursing mothers or their infants. Since there are no guidelines or data provided, it’s advisable to consult your healthcare provider for personalized advice. They can help you weigh the benefits and risks based on your individual situation. Always prioritize your health and your baby's well-being when making decisions about medication during breastfeeding.

Pediatric Use

It's important to keep this product out of reach of children under 6 years old. If your child accidentally swallows more than the amount used for brushing, seek medical help or contact a poison control center right away.

For children aged 6 and older, encourage them to brush their teeth thoroughly, ideally after each meal or at least twice a day, following the advice of a dentist or physician. For children aged 2 to 6, use only a pea-sized amount of the product and supervise their brushing and rinsing to help prevent swallowing. If your child is under 2 years old, consult with a dentist or physician before use.

Geriatric Use

While there is no specific information about the use of RAIN BREEZE TOOTHPASTE in older adults, it’s always wise to approach any new product with caution. If you or a loved one is considering using this toothpaste, it’s a good idea to consult with a healthcare professional, especially if there are any existing health concerns or medications involved.

Since the drug insert does not mention dosage adjustments or safety precautions for elderly patients, you should monitor for any unusual reactions or sensitivities when starting this product. Always prioritize open communication with your healthcare provider to ensure the best care tailored to your needs.

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 is safe and effective for your specific condition. They can help determine the best approach for managing your health, especially if you have concerns about your kidneys.

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 or tests you may be taking. In this case, there are no known drug interactions or laboratory test interactions associated with the medication. However, always ensure that your healthcare provider is aware of all the medications you are using, as this helps them provide the best care tailored to your needs. Your safety and well-being are the top priority, so don't hesitate to ask questions or share concerns during your appointments.

Storage and Handling

To ensure the safety and effectiveness of your product, store it at room temperature. This helps maintain its quality and performance. Additionally, it's important to keep the product out of reach of children under 6 years of age to prevent any accidental misuse or ingestion.

When handling the product, always follow any specific instructions provided to ensure safe use. If you have any questions about proper handling or storage, don't hesitate to reach out for guidance.

Additional Information

The medication is administered through the dental route, meaning it is used in dental care settings. It's important to keep this product out of reach of children 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 right away.

FAQ

What is the main use of this drug?

This drug helps protect against cavities.

What should adults and children 6 years of age and older do when using this drug?

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

How should children aged 2 to 6 use this drug?

Use only a pea-sized amount and supervise the child’s brushing and rinsing to minimize swallowing.

What should parents do for children under 2 years of age?

Ask a dentist or physician for guidance.

Are there any warnings associated with this drug?

Keep out of reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a poison control center immediately.

Are there any contraindications for this drug?

No contraindications are listed.

Is this drug safe to use during pregnancy?

No specific information regarding use during pregnancy is provided.

How should this drug be stored?

Store at room temperature and keep out of reach of children under 6 years of age.

Packaging Info

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

Packaging configurations for Rain Breeze Toothpaste.
Details

Drug Information (PDF)

This file contains official product information for Rain Breeze Toothpaste, 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 SPL code 34089-3. No additional specific description details are provided in the available text.

Uses and Indications

This drug is indicated for the protection against cavities.

There are no teratogenic effects associated with this drug, nor are there any nonteratogenic effects mentioned.

Dosage and Administration

Adults and children aged 6 years and older should brush their teeth thoroughly, preferably after each meal or at least twice daily, or as directed by a dentist or physician.

For children aged 2 to 6 years, a pea-sized amount of the product should be used. It is essential to supervise the child's brushing and rinsing to minimize the risk of swallowing.

For children under 2 years of age, it is recommended to consult a dentist or physician for appropriate guidance on usage.

Contraindications

There are no contraindications associated with the use of this product. It is not classified as a controlled substance, and there are no known risks of abuse, misuse, or dependence. Additionally, there are no specific instructions indicating that the product should not be taken or used under any circumstances.

Warnings and Precautions

It is imperative to keep this product out of the reach of children under 6 years of age to prevent accidental ingestion and potential harm.

In the event that more than the recommended amount used for brushing is accidentally swallowed, 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 of the following warnings associated with the use of this product. It is crucial to keep the product out of reach of children under 6 years of age to prevent accidental ingestion. In the event that more than the recommended amount for brushing is accidentally swallowed, it is imperative to seek medical assistance or contact a poison control center immediately.

These precautions are essential to ensure the safety and well-being of patients, particularly young children who may be more susceptible to adverse effects from improper use.

Drug Interactions

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

Packaging & NDC

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

Packaging configurations for Rain Breeze Toothpaste.
Details

Pediatric Use

Pediatric patients under 6 years of age should be kept out of reach of the product. In the event that more than the recommended amount for brushing is accidentally swallowed, medical assistance or contact with a poison control center is advised immediately.

For children aged 6 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 aged 2 to 6 years, 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 recommended prior to use.

Geriatric Use

There is no specific information regarding the use of RAIN BREEZE TOOTHPASTE in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when recommending this product to elderly patients, as the absence of data necessitates careful consideration of individual patient factors and potential risks. Monitoring for any adverse effects or unusual reactions in this population is advisable, given the lack of targeted studies or guidelines.

Pregnancy

There is no specific information regarding the use of RAIN BREEZE TOOTHPASTE during pregnancy, including safety concerns, dosage modifications, or special precautions. Healthcare professionals should consider the absence of data when advising pregnant patients or women of childbearing potential. It is recommended that the potential risks and benefits be evaluated on a case-by-case basis, taking into account the lack of established safety information for this product in pregnant individuals.

Lactation

There is no relevant information regarding nursing mothers or lactation considerations available in the provided text. Therefore, the effects of this medication on breastfed infants and its excretion in breast milk remain undetermined. Healthcare professionals should exercise caution and consider the potential risks and benefits when prescribing this medication to lactating mothers.

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, 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 use of the compound in question. Further studies may be necessary to fully evaluate the nonclinical toxicology profile.

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 includes specific NDC numbers, which are essential for identification and inventory management. It is recommended to store the product at room temperature to maintain its efficacy and stability. Additionally, it is crucial to keep the product out of reach of children under 6 years of age to ensure safety and prevent accidental ingestion. Proper handling and storage practices should be followed to ensure the product remains effective and safe for use.

Additional Clinical Information

The route of administration for the product is dental. Clinicians should advise patients to keep the product out of reach of children under 6 years of age. In the event that more than the recommended amount used for brushing is accidentally swallowed, patients should seek medical assistance or contact a poison control center immediately.

Drug Information (PDF)

This file contains official product information for Rain Breeze Toothpaste, 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 Rain Breeze Toothpaste, 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.