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Oralline Kids

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Active ingredient
Sodium Fluoride 0.15 g/100 g
Other brand names
Dosage form
Gel, Dentifrice
Route
Oral
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2025
Label revision date
March 21, 2025
Active ingredient
Sodium Fluoride 0.15 g/100 g
Other brand names
Dosage form
Gel, Dentifrice
Route
Oral
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2025
Label revision date
March 21, 2025
Manufacturer
J. M. Murray Center Inc.
Registration number
M021
NDC roots
55873-003, 55873-004

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Drug Overview

OraLine Kids Fluoride Toothpaste is a specially formulated toothpaste designed for children. It is accepted by the American Dental Association (ADA) for its effectiveness in helping to prevent and reduce tooth decay when used as directed. The fluoride in the toothpaste works to protect against cavities, making it a valuable part of your child's oral hygiene routine.

This toothpaste is free from animal-based ingredients and comes in a pleasant berry flavor, making brushing more enjoyable for kids. By incorporating OraLine Kids Fluoride Toothpaste into your child's daily routine, you can help support their dental health and keep their smiles bright.

Uses

Using this product can help protect your teeth against cavities, making it an important part of your oral hygiene routine. When used as directed, it is effective in preventing and reducing tooth decay, which is essential for maintaining healthy teeth and gums.

You can feel confident knowing that there are no teratogenic effects (harmful effects on fetal development) associated with this product, ensuring its safety for use.

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 a parent, make sure to guide your child in developing good brushing habits.

For children under 6 years old, use only a pea-sized amount of toothpaste. It's essential to supervise them while brushing to help them learn proper techniques and to prevent swallowing the toothpaste. With your guidance, they can become more independent in their oral care as they grow older.

What to Avoid

It's important to be cautious when using this medication. If you have a child under 2 years old, please consult a doctor or dentist before use. Additionally, make sure to keep this medication out of reach of children under 6 years of age to prevent any accidental ingestion.

While there are no specific contraindications or concerns about abuse, misuse, or dependence mentioned, always use medications responsibly and as directed. If you have any questions or concerns, don't hesitate to reach out to a healthcare professional for guidance.

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 right away. This is a serious situation that requires prompt attention.

Please be aware that while using this product, you should monitor for any unusual reactions and consult a healthcare professional if you have concerns. Your safety is a priority, so don’t hesitate to reach out for help if needed.

Warnings and Precautions

If you accidentally swallow more of this product than intended 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.

Always use this product as directed to avoid any potential risks. If you have any concerns or experience unusual symptoms, stop using the product and call your doctor for further advice. Your health and safety are the top 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. Overdosing can lead to serious health issues, so don’t hesitate to get assistance.

Signs of an overdose may not always be obvious, but if you experience any unusual symptoms after swallowing too much, it’s crucial to act quickly. Always prioritize your health and safety by reaching out for help if you suspect an overdose has occurred.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that the safety of sodium fluoride during pregnancy has not been established. While there are no specific contraindications mentioned, caution is advised since the effects on the fetus are not well-documented. Currently, there are no guidelines for dosage modifications for pregnant individuals, and no special precautions have been outlined regarding its use during pregnancy.

As always, it's best to discuss any medications or supplements with your healthcare provider to ensure the safety of you and your baby.

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 passed into breast milk or if it poses any risk to your infant. Always consult with your healthcare provider if you have any concerns or questions about medications while breastfeeding.

Pediatric Use

It's important to establish good dental hygiene habits for your child early on. 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.

If your child is under 6 years old, use only a pea-sized amount of toothpaste and teach them proper brushing and rinsing techniques to minimize the risk of swallowing. Always supervise younger children while they brush until they can do it safely on their own. For children under 2 years of age, it's best to consult with a doctor or dentist before using any toothpaste.

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 considering this medication, it’s important to consult with a healthcare provider. 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 your medication dosage may need to be adjusted. This is because your kidneys may not process the medication as effectively. Regular monitoring of your kidney function tests is essential to ensure your safety and the effectiveness of your treatment.

When determining the right dosage for you, healthcare providers will consider your creatinine clearance (a measure of how well your kidneys are filtering waste). Always communicate with your doctor about your kidney health to ensure you receive the best care tailored to your needs.

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 want 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 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 feel free to ask questions and share your complete list of medications and any lab tests you may be undergoing. This way, you can receive the best possible care tailored to your needs.

Storage and Handling

To ensure the best performance of your product, store it at room temperature and keep it away from direct light. It's important to keep the tube tightly closed when not in use to maintain its integrity. If you open the tube and do not use the contents within a specified time frame, please discard it to ensure safety and effectiveness. Following these guidelines will help you handle the product safely and effectively.

Additional Information

You will take this medication orally. It's important to maintain good brushing and rinsing habits to minimize the risk of swallowing the medication. If children are using this medication, make sure to supervise them until they are able to use it safely on their own.

FAQ

What is OraLine Kids Fluoride Toothpaste used for?

OraLine Kids Fluoride Toothpaste helps protect against cavities and is effective in preventing and reducing tooth decay when used as directed.

What age group can use OraLine Kids Fluoride Toothpaste?

OraLine Kids Fluoride Toothpaste is suitable for adults and children 2 years of age and older. Children under 2 years should consult a doctor or dentist.

How should children under 6 years use this toothpaste?

Children under 6 years should use a pea-sized amount and be supervised to ensure they practice good brushing and rinsing habits to reduce swallowing.

Are there any contraindications for using OraLine Kids Fluoride Toothpaste?

No specific contraindications are mentioned, but caution is advised for children under 2 years of age.

Is OraLine Kids Fluoride Toothpaste safe to use during pregnancy?

Safety during pregnancy has not been established, and caution is advised as the safety of sodium fluoride during pregnancy is not well-documented.

What should I do if I accidentally swallow more toothpaste than used for brushing?

If you accidentally swallow more than used for brushing, get medical help or contact a poison control center immediately.

How should OraLine Kids Fluoride Toothpaste be stored?

Store OraLine Kids Fluoride Toothpaste at room temperature, protect it from light, and keep the tube tightly closed when not in use.

Are there any specific warnings for nursing mothers?

There are no specific warnings or recommendations regarding the use of this product in nursing mothers.

What should I do if I have renal impairment?

If you have renal impairment, dosage adjustments may be necessary, and renal function tests should be monitored regularly.

Packaging Info

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

Packaging configurations for Oralline Kids.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

OraLine Kids Fluoride Toothpaste is an ADA accepted product, recognized by the ADA Council on Scientific Affairs for its efficacy in preventing and reducing tooth decay when used as directed. This toothpaste is formulated without any animal-based ingredients, ensuring it meets specific dietary preferences. It features a berry flavor, appealing to children while promoting oral health.

Uses and Indications

This drug is indicated for the protection against cavities and is effective in preventing and reducing tooth decay when used as directed.

There are no teratogenic or nonteratogenic effects associated with this drug.

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 daily, or as directed by a dentist or physician.

For children under 6 years of age, a pea-sized amount of toothpaste should be used. It is essential to instruct these children in proper brushing and rinsing techniques to minimize the risk of swallowing the toothpaste. Caregivers should supervise children during brushing until they are capable of performing the task independently.

Contraindications

Use is contraindicated in children under 2 years of age unless directed by a healthcare professional. Additionally, the product should be kept out of the reach of children under 6 years of age to prevent accidental ingestion or misuse.

Warnings and Precautions

In the event of accidental ingestion of an amount exceeding that typically used for brushing, it is imperative to seek immediate medical assistance or contact a poison control center. This precaution is critical to ensure the safety and well-being of the patient. Healthcare professionals should be vigilant in educating patients about the appropriate use of the product to prevent such occurrences.

Side Effects

Patients should be aware of the potential risks associated with the use of this product. In the event of accidental ingestion of more than the recommended amount for brushing, it is imperative to seek medical assistance or contact a poison control center immediately. This warning highlights the importance of adhering to the recommended usage guidelines to prevent serious adverse reactions.

While specific adverse reactions were not detailed in clinical trials or postmarketing experiences, the emphasis on seeking immediate help in cases of overconsumption underscores the necessity for caution among users.

Drug Interactions

There are currently no specific drug interactions identified for the medication. Additionally, no interactions with laboratory tests have been reported. Therefore, no dosage adjustments or monitoring recommendations are necessary at this time. It is advisable for healthcare professionals to remain vigilant and consult updated resources as new data may emerge.

Packaging & NDC

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

Packaging configurations for Oralline Kids.
Details

Pediatric Use

Pediatric patients 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 doctor. For children under 6 years of age, a pea-sized amount of product should be used, and caregivers should instruct on proper brushing and rinsing techniques to minimize the risk of swallowing. Supervision is recommended until the child is capable of brushing without assistance. For infants and children under 2 years of age, consultation with a doctor or dentist is recommended prior to use.

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

Safety during pregnancy has not been established for this medication. While there are no specific contraindications noted, caution is advised due to the lack of well-documented safety data regarding the use of sodium fluoride in pregnant patients. There is no specific information available concerning risks to the fetus. Additionally, no dosage modifications for pregnant individuals have been specified, and no special precautions regarding use during pregnancy are provided. Healthcare professionals should weigh the potential benefits against the unknown risks when considering this medication for women of childbearing potential.

Lactation

There are no specific warnings or recommendations regarding the use of this product in nursing mothers. Additionally, there is no information available concerning the potential for excretion in breast milk or any associated risks to breastfed infants.

Renal Impairment

Dosage adjustments may be necessary for patients with reduced renal function. It is important to monitor renal function tests regularly in patients with known kidney issues. Additionally, creatinine clearance should be considered when determining the appropriate dosage for patients with renal impairment.

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, it is imperative that immediate medical assistance is sought. Healthcare professionals should advise patients to contact a poison control center or seek medical help without delay if they accidentally ingest more than the recommended amount used for brushing.

Symptoms of overdosage may vary, and it is crucial for healthcare providers to monitor the patient closely for any adverse effects. Prompt recognition and management of symptoms are essential to mitigate potential complications.

Management procedures should include supportive care and symptomatic treatment as necessary. It is recommended that healthcare professionals remain vigilant and prepared to provide appropriate interventions based on the clinical presentation of the patient.

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 compound in these areas.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients that children under 2 years of age should consult a doctor or dentist before using this product. It is important to emphasize the necessity of professional guidance in this age group to ensure safety and appropriate use.

Additionally, healthcare providers should instruct patients to keep this product out of the reach of children under 6 years of age. This precaution is vital to prevent accidental ingestion or misuse, thereby safeguarding the health and well-being of young children.

Storage and Handling

The product is supplied in a tube format, with specific handling and storage requirements to ensure its integrity and effectiveness. It should be stored at room temperature, away from direct light exposure. To maintain the quality of the product, it is essential to keep the tube tightly closed when not in use. Additionally, any unused product should be discarded after opening if it is not utilized within the specified time frame.

Additional Clinical Information

The route of administration for the medication is oral. Clinicians should instruct patients on proper brushing and rinsing techniques to minimize the risk of swallowing the medication. It is important to supervise children until they are capable of using the medication without assistance.

Drug Information (PDF)

This file contains official product information for Oralline Kids, 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 Oralline Kids, 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.