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Arc

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This product has been discontinued

Active ingredient
Sodium Fluoride 1.4 mg/1 g
Other brand names
Dosage form
Paste, Dentifrice
Route
Dental
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2021
Label revision date
July 31, 2025
Active ingredient
Sodium Fluoride 1.4 mg/1 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 2021
Label revision date
July 31, 2025
Manufacturer
Procter & Gamble Manufacturing Company
Registration number
M021
NDC root
69423-890

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If you are a consumer or patient please visit this version.

Drug Overview

ARC Whitening Fluoride Toothpaste is a specialized toothpaste designed to help protect against cavities while also providing whitening benefits. It contains fluoride, a common ingredient known for its ability to strengthen tooth enamel and reduce the risk of cavities. With a refreshing mint flavor, this toothpaste not only promotes oral health but also helps enhance the brightness of your smile.

Uses

You can use this product to help protect your teeth against cavities. Cavities are small holes that can form in your teeth due to decay, often caused by bacteria. By using this product, you can support your dental health and reduce the risk of developing these issues. Regular use can be an important part of maintaining a healthy smile.

Dosage and Administration

It's important to take care of your teeth, and brushing is a key part of that routine. If you are an adult or have a child who is 2 years or older, make sure to brush your teeth thoroughly after meals or at least twice a day. You can also follow any specific instructions given by your dentist. Remember, do not swallow the toothpaste.

For children under 6, use only a pea-sized amount of toothpaste to help minimize the chance of swallowing. It's a good idea to supervise young children while they brush their teeth until they develop good habits. If your child is under 2 years old, it's best to consult with a dentist for guidance on how to care for their teeth.

What to Avoid

It's important to keep this product out of reach of children under 6 years old to ensure their safety. If a child accidentally swallows more than what is typically used for brushing, seek medical help or contact a Poison Control Center immediately.

There are no specific contraindications, controlled substance classifications, or concerns regarding abuse, misuse, or dependence associated with this product. However, always use it as directed to avoid any potential issues.

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 their teeth, seek medical help or contact a Poison Control Center immediately. This ensures their safety and addresses any potential risks quickly.

Warnings and Precautions

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 their teeth, you should seek medical help or contact a Poison Control Center immediately.

Always use this product as directed and be aware of any unusual reactions. If you experience any concerning symptoms or side effects, stop using the product and call your doctor for 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 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

There is currently no specific information available about the use of ARC WHITENING - sodium fluoride paste during pregnancy. This means that safety concerns, dosage adjustments, or any special precautions for pregnant individuals have not been addressed in the drug insert.

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 dental care items like fluoride paste. They can provide personalized advice based on your health needs.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding nursing mothers or lactation in the information provided. This means that, based on the available data, there are no known risks associated with breastfeeding while using this medication. However, it's always a good idea to consult with your healthcare provider if you have any concerns or questions about your specific situation.

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 what is needed for brushing, seek medical help or contact a Poison Control Center immediately. For children aged 2 years and older, encourage them to brush their teeth thoroughly after meals or at least twice a day, following your dentist's advice.

To help prevent swallowing, use only a pea-sized amount for children under 6, and always supervise their brushing until they develop good habits. If your child is under 2 years old, consult with a dentist 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. Since older adults may have different health needs and responses to medications, you should always consult with a healthcare provider before starting any new medication. They can help determine the right dosage and monitor for any potential side effects, ensuring that the treatment is safe and effective for you or your loved one.

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 information provided does not include specific guidelines for dosage adjustments, special monitoring, or precautions related to your condition. This means that there are no tailored recommendations for how the medication may affect you differently due to your liver health.

Always consult your healthcare provider for personalized advice and to ensure that any treatment plan is safe and effective for your specific situation. They can help determine the best approach based on your liver function and overall health.

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 provide the best care tailored to your needs.

Always feel free to ask questions and share all the medications and supplements you are using. This helps your provider monitor your health effectively and make informed decisions about your treatment.

Storage and Handling

To ensure the best performance of your product, store it at room temperature and keep it away from freezing conditions. It's important to handle the product carefully and to discard it after opening to maintain safety and effectiveness. Following these guidelines will help you use the product safely and effectively.

Additional Information

No further information is available.

FAQ

What is ARC Whitening Fluoride Toothpaste used for?

ARC Whitening Fluoride Toothpaste helps protect against cavities and is specifically designed for whitening.

What is the recommended usage for adults and children?

Adults and children 2 years and older should brush their teeth thoroughly after meals or at least twice a day, or use as directed by a dentist.

What should I do if a child under 6 accidentally swallows the toothpaste?

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

How should I supervise children using this toothpaste?

You should supervise children's brushing until good habits are established and use a pea-sized amount to minimize swallowing in children under 6.

Is there any information regarding the use of this toothpaste during pregnancy or nursing?

There are no specific warnings or recommendations regarding the use of ARC Whitening Fluoride Toothpaste during pregnancy or nursing.

Are there any contraindications or drug interactions with this toothpaste?

No specific contraindications or drug interactions are mentioned for ARC Whitening Fluoride Toothpaste.

How should I store ARC Whitening Fluoride Toothpaste?

Store the toothpaste at room temperature, protect it from freezing, and discard it after opening.

Packaging Info

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

Packaging configurations for Arc.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

ARC Whitening Fluoride Toothpaste is formulated with fluoride to aid in the prevention of dental cavities. This toothpaste is presented in a fresh mint flavor, providing a refreshing taste during use. The product is packaged in a net weight of 4.0 ounces (113 grams).

Uses and Indications

This drug is indicated for the protection against dental cavities. It is designed to support oral health by reducing the risk of cavity formation in patients.

Dosage and Administration

Adults and children aged 2 years and older are advised to brush their teeth thoroughly after meals or at least twice daily, or as directed by a dentist. It is important to ensure that the product is not swallowed during use.

For children under 6 years of age, a pea-sized amount should be used to minimize the risk of swallowing. Caregivers should supervise the brushing of teeth in children until proper oral hygiene habits are established.

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

Contraindications

Use is contraindicated in children under 6 years of age due to the potential risk of accidental ingestion. In the event of accidental swallowing of an amount exceeding that used for brushing, immediate medical assistance should be sought or contact with a Poison Control Center is advised.

Warnings and Precautions

It is imperative to keep this product out of the reach of children under 6 years of age. In the event that more than the recommended amount used for brushing is accidentally swallowed, immediate medical assistance should be sought, or contact with a Poison Control Center is advised without delay.

Healthcare professionals should ensure that caregivers are aware of these precautions to prevent accidental ingestion and to promote safe usage among young children.

Side Effects

Patients should be advised to keep this 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, it is imperative to seek medical assistance or contact a Poison Control Center immediately. This warning highlights the potential risks associated with accidental ingestion, underscoring the importance of proper usage and supervision.

Drug Interactions

There are no specific drug interactions identified for the product, nor are there any noted interactions with laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on the available data.

Packaging & NDC

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

Packaging configurations for Arc.
Details

Pediatric Use

Pediatric patients under 6 years of age should be supervised during brushing to establish good oral hygiene habits. A pea-sized amount of the product is recommended for children in this age group to minimize swallowing. It is advised that children under 2 years of age consult a dentist before use.

For children aged 2 years and older, the product should be used to brush teeth thoroughly after meals or at least twice a day, or as directed by a dentist. It is important to instruct pediatric patients not to swallow the product. In the event of accidental ingestion of more than the amount used for brushing, medical assistance or contact with a Poison Control Center is necessary.

Additionally, the product should be kept out of reach of children under 6 years of age to prevent accidental ingestion.

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.

Pregnancy

There is no specific information regarding the use of ARC WHITENING - sodium fluoride paste, dentifrice during pregnancy. As such, safety concerns, dosage modifications, or special precautions for pregnant patients have not been established. Healthcare professionals should consider the lack of data when advising women of childbearing potential and weigh the benefits against any potential risks when recommending this product during pregnancy.

Lactation

There are no specific warnings or recommendations regarding the use of this medication in nursing mothers. Additionally, there are no specific warnings or recommendations related to lactation. Healthcare professionals should consider the absence of data when advising lactating mothers about the use of this medication.

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 any 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 compound 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 product out of reach of children under 6 years of age to prevent accidental ingestion. It is important to emphasize the potential risks associated with misuse. Instruct patients that if more than the recommended amount used for brushing is accidentally swallowed, they should seek medical help or contact a Poison Control Center immediately. This guidance is crucial for ensuring the safety and well-being of patients and their families.

Storage and Handling

The product is supplied in configurations that include specific NDC numbers. It should be stored at room temperature, ensuring that it is protected from freezing conditions. Once opened, the product must be discarded to maintain safety and efficacy.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Arc, 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 Arc, 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.